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SPECTRI: A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT02247531
Collaborator
(none)
975
Enrollment
153
Locations
3
Arms
39.6
Actual Duration (Months)
6.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
975 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date :
Oct 6, 2014
Actual Primary Completion Date :
Jan 23, 2018
Actual Study Completion Date :
Jan 23, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lampalizumab once in every 4 weeks (Q4W)

Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.

Drug: Lampalizumab
10 mg dose of lampalizumab administered intravitreally.
Other Names:
  • RO5490249

    		•
    Experimental: Lampalizumab once in every 6 weeks (Q6W)

    Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.

    Drug: Lampalizumab
    10 mg dose of lampalizumab administered intravitreally.
    Other Names:
  • RO5490249

    		•
    Sham Comparator: Sham Comparator

    Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.

    Other: Sham Comparator
    A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 [Baseline, Week 48]

      The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).

    2. Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48 [Baseline, Week 48]

      For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).

    Secondary Outcome Measures

    1. Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48 [Baseline, Week 48]

      Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.

    2. Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48 [Baseline, Week 48]

      Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.

    3. Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48 [Baseline, Week 48]

      BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.

    4. Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48 [Week 48]

      Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.

    5. Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48 [Baseline, Week 48]

      The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.

    6. Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48 [Week 48]

      Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.

    7. Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48 [Baseline, Week 48]

      MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.

    8. Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48 [Baseline, Week 48]

      MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    9. Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48 [Baseline, Week 48]

      NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.

    10. Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48 [Baseline, Week 48]

      NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    11. Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48 [Baseline, Week 48]

      NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    12. Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48 [Baseline, Week 48]

      The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants aged greater than or equal to (>/=) 50 years

    • Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

    Exclusion Criteria:
    Ocular Exclusion Criteria (Study Eye):

    • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD

    • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy

    • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)

    Ocular Exclusion Criteria (Both Eyes):

    • GA in either eye due to causes other than AMD

    • Previous treatment with eculizumab, lampalizumab, and/or fenretinide

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Associated Retina Consultants Phoenix Arizona United States 85020
    2 Retina Associates Southwest PC Tucson Arizona United States 85750
    3 Retina Consultants of Orange County Fullerton California United States 92835
    4 UCSD Shiley Eye Center La Jolla California United States 92093-0946
    5 Jules Stein Eye Institute/ UCLA Los Angeles California United States 90095-7000
    6 N CA Retina Vitreous Assoc Mountain View California United States 94040
    7 Byers Eye Insitute at Stanford Palo Alto California United States 94303
    8 Retina Consultants, San Diego Poway California United States 92064
    9 University of California, Davis, Eye Center Sacramento California United States 95817
    10 Retinal Consultants Med Group Sacramento California United States 95841
    11 California Retina Consultants Santa Barbara California United States 93103
    12 Bay Area Retina Associates Walnut Creek California United States 94598
    13 University of Colorado Aurora Colorado United States 80045
    14 Retina Consultants of Southern Colorado Springs Colorado United States 80909
    15 Colorado Retina Associates, PC Golden Colorado United States 80401
    16 New England Retina Associates Hamden Connecticut United States 06518
    17 Retina Group of New England Waterford Connecticut United States 06385
    18 Retina Group of Florida Fort Lauderdale Florida United States 33308
    19 Retina Health Center Fort Myers Florida United States 33907
    20 Bascom Palmer Eye Institute Naples Florida United States 34103
    21 Retina Vitreous Assoc of FL Saint Petersburg Florida United States 33711
    22 Southern Vitreoretinal Assoc Tallahassee Florida United States 32308
    23 University of South Florida Tampa Florida United States 33612
    24 Emory University Atlanta Georgia United States 30329
    25 Wolfe Eye Clinic West Des Moines Iowa United States 50266
    26 Vitreo Retinal Consultants Wichita Kansas United States 67214
    27 Paducah Retinal Center Paducah Kentucky United States 42001
    28 The Retina Care Center Baltimore Maryland United States 21209
    29 Wilmer Eye Institute Baltimore Maryland United States 21287
    30 Retina Group of Washington Chevy Chase Maryland United States 20815
    31 Retina Specialists Towson Maryland United States 21204
    32 Mass Eye and Ear Infirmary Boston Massachusetts United States 02114
    33 University of Michigan, Kellogg Eye Center Ann Arbor Michigan United States 48105
    34 Kresge Eye Institute Detroit Michigan United States 48201-1423
    35 Vitreoretinal Surgery Edina Minnesota United States 55435
    36 Midwest Vision Research Foundation Chesterfield Missouri United States 63017
    37 UNMC Truhlsen Eye Institute Omaha Nebraska United States 68105
    38 Sierra Eye Associates Reno Nevada United States 89502
    39 Mid Atlantic Retina - Wills Eye Hospital Cherry Hill New Jersey United States 08034
    40 Retinal & Ophthalmic Cons PC Northfield New Jersey United States 08225
    41 Retina Associates of NJ Teaneck New Jersey United States 07666
    42 New York Weil Cornell Med Ctr New York New York United States 10021
    43 Vitreous-Retina-Macula New York New York United States 10022
    44 Retina Assoc of Western NY Rochester New York United States 14620
    45 Western Carolina Retinal Associate PA Asheville North Carolina United States 28803
    46 Char Eye Ear &Throat Assoc Charlotte North Carolina United States 28210
    47 Duke University Eye Center; Vitreoretinal Durham North Carolina United States 27710
    48 Cincinnati Eye Institute Cincinnati Ohio United States 45242
    49 OSU Eye Physicians & Surgeons Columbus Ohio United States 43212
    50 Retina & Vitreous Center of Southern Oregon Ashland Oregon United States 97520
    51 Retina Northwest Portland Oregon United States 97221
    52 Oregon HSU; Casey Eye Institute Portland Oregon United States 97239
    53 Mid Atlantic Retina Philadelphia Pennsylvania United States 19107
    54 Allegheny Ophthalmic & Orbital Pittsburgh Pennsylvania United States 15212
    55 MUSC Storm eye institute Charleston South Carolina United States
    56 Palmetto Retina Center Florence South Carolina United States 29501
    57 Charleston Neuroscience Inst Ladson South Carolina United States 29456
    58 Black Hills Eye Institute Rapid City South Dakota United States 57701
    59 Southeastern Retina Associates Chattanooga Chattanooga Tennessee United States 37421
    60 Charles Retina Institution Germantown Tennessee United States 38138
    61 Retina Res Institute of Texas Abilene Texas United States 79606
    62 Texas Retina Associates Dallas Texas United States 75231
    63 Retina Consultants of Houston Houston Texas United States 77030
    64 Scott and White Hospital Temple Texas United States 76504
    65 Retina Consultants of Houston The Woodlands Texas United States 77384
    66 Univ of Virginia Ophthalmology Charlottesville Virginia United States 22903
    67 Vitreoretinal Associates of Washington Bellevue Washington United States 98004
    68 Oftalmos Capital Federal Argentina C1120AAN
    69 Instituto de la Vision Capital Federal Argentina C1122AAI
    70 Hospital El Cruce Florencio Varela Argentina B1888AAE
    71 Queensland Eye Institute Brisbane Queensland Australia 4101
    72 Adelaide Eye and Retina Centre Adelaide South Australia Australia 5000
    73 Vision Eye Institute Eastern Box Hill Victoria Australia 3128
    74 Royal Victorian Eye and Ear Hospital East Melbourne Victoria Australia 3002
    75 The Lions Eye Institute Nedlands Western Australia Australia 6009
    76 Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie Wien Austria 1090
    77 CHU Brugmann (Victor Horta) Bruxelles Belgium 1020
    78 UZ Leuven Sint Rafael Leuven Belgium 3000
    79 Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37 Glostrup Denmark 2600
    80 Hopital Pellegrin; Ophtalmologie Bordeaux France 33000
    81 CHU Bocage; Ophtalmologie Dijon France 21079
    82 Hopital de la croix rousse; Ophtalmologie Lyon cedex France 69317
    83 Centre Paradis Monticelli; Ophtalmologie Marseille France 13008
    84 Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique Nantes France 44093
    85 CHNO des Quinze Vingts; Ophtalmologie Paris France 75012
    86 Universitätsklinikum Freiburg, Klinik für Augenheilkunde Freiburg Germany 79106
    87 Universitätsklinik Heidelberg; Augenklinik Heidelberg Germany 69120
    88 Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik Ludwigshafen Germany 67063
    89 Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik Mainz Germany 55131
    90 LMU Klinikum der Universität, Augenklinik München Germany 80336
    91 Klinikum rechts der Isar der TU München; Augenklinik München Germany 81675
    92 Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde Regensburg Germany 93053
    93 Universitätsklinikum Tübingen Tuebingen Germany 72076
    94 Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR Budapest Hungary 1076
    95 Semmelweis Egyetem AOK, Szemeszeti Klinika Budapest Hungary 1083
    96 Ganglion Medial Center Pécs Hungary 7621
    97 UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA Genova Liguria Italy 16132
    98 Irccs Ospedale San Raffaele;U.O. Oculistica Milano Lombardia Italy 20132
    99 ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco) Milano Lombardia Italy 20157
    100 A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico Torino Piemonte Italy 10122
    101 Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica Firenze Toscana Italy 50134
    102 A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica Udine Veneto Italy 33100
    103 Hospital Nuestra Señora de La Luz Mexico City Mexico 06030
    104 Hospital Universitario de Monterrey Monterrey Mexico 64040
    105 Instituto Mexicano de Oftalmologia I.A.P. Querétaro Mexico 76090
    106 Radboud University Nijmegen Medical Centre; Ophthalmology Nijmegen Netherlands 6525 EX
    107 Erasmus Medisch Centrum Rotterdam Netherlands 3015 GD
    108 Mácula D&T Lima Peru 27
    109 TG Laser Oftalmica Lima Peru 27
    110 Centro de Investigacion Oftalmolaser Lima Peru 33
    111 OFTALMIKA Sp. z o.o Bydgoszcz Poland 85-631
    112 Szpital Specjalistyczny nr 1; Oddzial Okulistyki Bytom Poland 41-902
    113 Uniwersytecki Szpital Kliniczny; Klinika Okulistyki Wrocław Poland 50-556
    114 Klinika Okulistyczna Jasne Błonia Łódź Poland 91-134
    115 AIBILI - Association for Innovation and Biomedical Research on Light Coimbra Portugal 3000-548
    116 Espaco Medico Coimbra Coimbra Portugal 3030-163
    117 Hospital de Santa Maria; Servico de Oftalmologia Lisboa Portugal 1649-035
    118 Hospital de Sao Joao; Servico de Oftalmologia Porto Portugal 4200-319
    119 SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic" Kazan Russian Federation 420012
    120 FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences Moscow Russian Federation 119435
    121 St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology Samara Russian Federation 443068
    122 FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU Banska Bystrica Slovakia 975 17
    123 Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB Bratislava Slovakia 851 07
    124 Instituto Oftalmologico Gomez Ulla Santiago de Compostela LA Coruña Spain 15706
    125 Clinica Universitaria de Navarra; Servicio de Oftalmologia Pamplona Navarra Spain 31008
    126 Hospital Perpetuo Socorro; Servicio de Oftalmología Albacete Spain 02006
    127 Instituto de microcirugia ocular Barcelona Spain 08035
    128 VISSUM Madrid Santa Hortensia Madrid Spain 28002
    129 Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia Madrid Spain 28040
    130 Hospital Universitario la Fe: Servicio de Oftalmologia Valencia Spain 46026
    131 St Eriks Eye Hospital Stockholm Sweden SE-112 82
    132 Inselspital Bern, Universitätsklinik für Augenheilkunde Bern Switzerland 3010
    133 Vista Klinik Binningen Binningen Switzerland 4102
    134 Hacettepe University Medical Faculty; Department of Ophthalmology Ankara Turkey 06100
    135 Ankara University Medical Faculty; Department of Ophthalmology Ankara Turkey 06340
    136 Ankara Baskent University Medical Faculty; Department of Ophthalmology Ankara Turkey 06490
    137 Istanbul University Istanbul Medical Faculty; Department of Ophthalmology Istanbul Turkey 34093
    138 Ege University Medical Faculty; Department of Ophthalmology Izmir Turkey 35100
    139 Dokuz Eylul University Medical Faculty; Department of Ophthalmology Izmir Turkey 35340
    140 Royal Victoria Hospital Belfast United Kingdom BT12 6BA
    141 Bradford Royal Infirmary Bradford United Kingdom BD9 6RJ
    142 Bristol Eye Hospital Bristol United Kingdom BS1 2LX
    143 University Hospital of Wales Cardiff United Kingdom CF14 4XW
    144 Gloucestershire Hospitals NHS Foundation Trust Gloucestershire United Kingdom GL1 3NN
    145 Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre Liverpool United Kingdom L7 8XP
    146 Moorfields Eye Hospital NHS Foundation Trust London United Kingdom EC1V 2PD
    147 Kings College Hospital London United Kingdom SE5 9RS
    148 Macular Treatment Centre; Royal Eye Hospital Manchester United Kingdom M13 9WL
    149 Hillingdon Hospital Middx United Kingdom UB8 3NN
    150 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP
    151 Southampton General Hospital Southampton United Kingdom SO16 6YD
    152 The Royal Wolverhampton Hospitals NHS Trust Wolverhampton United Kingdom WV10 0QP
    153 The York Hospital York United Kingdom YO31 8HE

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02247531
    Other Study ID Numbers:
    • GX29185
    • 2014-000106-35
    First Posted:
    Sep 25, 2014
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Macular Degeneration
    Geographic Atrophy
    Atrophy

    Study Results

    Participant Flow

    Recruitment Details A total of 975 participants were randomized to the study at 144 study sites across 22 countries. The study was terminated early by the Sponsor due to lack of efficacy.
    Pre-assignment Detail This study enrolled participants with bilateral Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) and no signs of prior or active choroidal neovascularization (CNV), age >= 50 years with a valid complement factor I (CFI)-profile biomarker result.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Period Title: Overall Study
    STARTED 321 330 324
    COMPLETED 215 205 214
    NOT COMPLETED 106 125 110

    Baseline Characteristics

    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W Total
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit. Total of all reporting groups
    Overall Participants 321 330 324 975
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    77.6
    (8.3)
    77.3
    (7.8)
    78.7
    (8.0)
    77.9
    (8.1)
    Sex: Female, Male (Count of Participants)
    Female
    191
    59.5%
    197
    59.7%
    190
    58.6%
    578
    59.3%
    Male
    130
    40.5%
    133
    40.3%
    134
    41.4%
    397
    40.7%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    12
    3.7%
    9
    2.7%
    16
    4.9%
    37
    3.8%
    Not Hispanic or Latino
    298
    92.8%
    310
    93.9%
    297
    91.7%
    905
    92.8%
    Not Stated
    7
    2.2%
    8
    2.4%
    8
    2.5%
    23
    2.4%
    Unknown
    4
    1.2%
    3
    0.9%
    3
    0.9%
    10
    1%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    2
    0.6%
    3
    0.9%
    1
    0.3%
    6
    0.6%
    Asian
    3
    0.9%
    1
    0.3%
    1
    0.3%
    5
    0.5%
    Black or African American
    0
    0%
    1
    0.3%
    0
    0%
    1
    0.1%
    Native Hawaiian or other Pacific Islander
    1
    0.3%
    0
    0%
    0
    0%
    1
    0.1%
    White
    306
    95.3%
    315
    95.5%
    315
    97.2%
    936
    96%
    Multiple
    2
    0.6%
    0
    0%
    1
    0.3%
    3
    0.3%
    Unknown
    7
    2.2%
    10
    3%
    6
    1.9%
    23
    2.4%
    Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) (millimeter square (mm^2)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [millimeter square (mm^2)]
    7.554
    (3.983)
    8.308
    (3.916)
    8.498
    (4.260)
    8.123
    (4.071)
    Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry (number of absolute scotomatous points) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [number of absolute scotomatous points]
    23.2
    (13.5)
    28.2
    (17.3)
    27.9
    (14.4)
    26.6
    (15.3)
    Macular Sensitivity as Assessed by Mesopic Microperimetry (decibel (dB)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [decibel (dB)]
    6.5
    (3.3)
    5.7
    (3.8)
    5.3
    (3.2)
    5.8
    (3.5)
    Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (letters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [letters]
    66.1
    (9.8)
    66.0
    (9.6)
    65.7
    (9.8)
    66.0
    (9.7)
    Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions (letters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [letters]
    36.8
    (16.5)
    36.1
    (17.5)
    35.8
    (16.8)
    36.2
    (16.9)
    Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test or Radner Reading Charts (words per minute (wpm)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [words per minute (wpm)]
    105.16
    (56.94)
    104.38
    (54.35)
    99.75
    (56.56)
    103.09
    (55.94)
    Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts (wpm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [wpm]
    81.20
    (57.48)
    80.38
    (53.70)
    74.52
    (50.11)
    78.70
    (53.85)
    National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    64.84
    (15.80)
    62.88
    (17.50)
    64.03
    (17.65)
    63.90
    (17.02)
    NEI VFQ-25 Near Activity Subscale Score (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    53.89
    (19.91)
    51.68
    (21.92)
    53.24
    (22.07)
    52.92
    (21.34)
    NEI VFQ-25 Distance Activity Subscale Score (scores on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [scores on a scale]
    62.68
    (21.41)
    58.57
    (22.03)
    60.95
    (21.55)
    60.70
    (21.71)
    Mean Functional Reading Independence (FRI) Index (score on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [score on a scale]
    2.70
    (0.79)
    2.66
    (0.82)
    2.64
    (0.87)
    2.67
    (0.83)
    GA Area in Complement Factor I (CFI) Positive Participants (mm^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mm^2]
    7.491
    (4.068)
    8.183
    (3.835)
    8.652
    (4.250)
    8.109
    (4.074)
    GA Area in CFI Negative Participants (mm^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mm^2]
    7.650
    (3.862)
    8.499
    (4.044)
    8.268
    (4.281)
    8.144
    (4.073)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
    Description The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM analysis).
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 291 293 291
    Mean (Standard Error) [millimeter square (mm^2)]
    1.932
    (0.056)
    2.089
    (0.056)
    2.019
    (0.056)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0479
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.157
    Confidence Interval (2-Sided) 95%
    0.001 to 0.313
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2739
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.087
    Confidence Interval (2-Sided) 95%
    -0.069 to 0.243
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48
    Description Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 39 42 43
    Mean (Standard Error) [number of absolute scotomatous points]
    5.4
    (1.6)
    5.0
    (1.5)
    6.7
    (1.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8400
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value -0.4
    Confidence Interval (2-Sided) 95%
    -4.8 to 3.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5587
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -3.1 to 5.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
    Description Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 39 41 42
    Mean (Standard Error) [decibel (dB)]
    -0.99
    (0.36)
    -0.89
    (0.34)
    -1.25
    (0.35)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8358
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.10
    Confidence Interval (2-Sided) 95%
    -0.88 to 1.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6117
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value -0.26
    Confidence Interval (2-Sided) 95%
    -1.25 to 0.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
    Description BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 288 286 287
    Mean (Standard Error) [letters]
    -5.3
    (0.7)
    -4.6
    (0.7)
    -5.1
    (0.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4651
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    -1.2 to 2.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7885
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.3
    Confidence Interval (2-Sided) 95%
    -1.6 to 2.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
    Description Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 288 286 287
    Number [percentage of participants]
    87.1
    27.1%
    88.2
    26.7%
    86.8
    26.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6892
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.1
    Confidence Interval (2-Sided) 95%
    0.7 to 1.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9104
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.0
    Confidence Interval (2-Sided) 95%
    0.6 to 1.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
    Description The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 274 278 274
    Mean (Standard Error) [letters]
    -2.5
    (0.6)
    -2.6
    (0.6)
    -3.6
    (0.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8931
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value -0.1
    Confidence Interval (2-Sided) 95%
    -1.8 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1754
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -2.8 to 0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
    Description Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 274 278 274
    Number [percentage of participants]
    90.1
    28.1%
    92.1
    27.9%
    89.6
    27.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3707
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    0.7 to 2.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8382
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    0.6 to 1.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
    Description MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 261 255 266
    Mean (Standard Error) [words per minute (wpm)]
    -15.27
    (2.33)
    -13.92
    (2.36)
    -14.20
    (2.31)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6841
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 1.35
    Confidence Interval (2-Sided) 95%
    -5.16 to 7.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7443
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 1.07
    Confidence Interval (2-Sided) 95%
    -5.37 to 7.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
    Description MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 264 264 272
    Mean (Standard Error) [wpm]
    -16.58
    (2.30)
    -16.46
    (2.30)
    -18.30
    (2.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9713
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.12
    Confidence Interval (2-Sided) 95%
    -6.28 to 6.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5945
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value -1.72
    Confidence Interval (2-Sided) 95%
    -8.08 to 4.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
    Description NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 251 259 265
    Mean (Standard Error) [score on a scale]
    -2.08
    (0.74)
    -0.86
    (0.73)
    -1.05
    (0.72)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2438
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 1.22
    Confidence Interval (2-Sided) 95%
    -0.83 to 3.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3202
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 1.03
    Confidence Interval (2-Sided) 95%
    -1.01 to 3.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
    Description NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 251 259 265
    Mean (Standard Error) [score on a scale]
    -4.12
    (0.91)
    -1.49
    (0.89)
    -1.93
    (0.88)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0388
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 2.64
    Confidence Interval (2-Sided) 95%
    0.14 to 5.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0833
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 2.20
    Confidence Interval (2-Sided) 95%
    -0.29 to 4.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
    Description NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 251 259 265
    Mean (Standard Error) [score on a scale]
    -2.83
    (1.04)
    -1.80
    (1.03)
    -2.24
    (1.01)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4795
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 1.04
    Confidence Interval (2-Sided) 95%
    -1.84 to 3.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6822
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.60
    Confidence Interval (2-Sided) 95%
    -2.26 to 3.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
    Description The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 248 257 260
    Mean (Standard Error) [score on a scale]
    -0.16
    (0.04)
    -0.12
    (0.04)
    -0.14
    (0.04)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5227
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.04
    Confidence Interval (2-Sided) 95%
    -0.07 to 0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7475
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.02
    Confidence Interval (2-Sided) 95%
    -0.09 to 0.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Primary Outcome
    Title Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
    Description For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    Measure Participants 321 330 324
    CFI-Positive Participants
    2.007
    (0.074)
    2.057
    (0.072)
    2.032
    (0.073)
    CFI-Negative Participants
    1.809
    (0.087)
    2.149
    (0.087)
    1.991
    (0.085)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.6333
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.049
    Confidence Interval (2-Sided) 95%
    -0.153 to 0.252
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.8105
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.025
    Confidence Interval (2-Sided) 95%
    -0.180 to 0.230
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q4W
    Comments CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0063
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.340
    Confidence Interval (2-Sided) 95%
    0.097 to 0.584
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Sham Comparator, Lampalizumab Q6W
    Comments CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1359
    Comments
    Method MMRM
    Comments
    Method of Estimation Estimation Parameter Difference in Adjusted Means
    Estimated Value 0.182
    Confidence Interval (2-Sided) 95%
    -0.058 to 0.422
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Up to approximately 2 years
    Adverse Event Reporting Description Safety population included all participants who received at least one dose of study drug.
    Arm/Group Title Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Arm/Group Description Participants received sham comparator, once every 4 weeks (Q4W) starting at the Day 1 visit or once every 6 weeks (Q6W) starting at the Day 1 visit. Participants received 10 mg (milligrams) dose of lampalizumab by intravitreal injection Q4W starting at the Day 1 visit. Participants received 10 mg dose of lampalizumab by intravitreal injection Q6W starting at the Day 1 visit.
    All Cause Mortality
    Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/318 (2.8%) 10/329 (3%) 7/323 (2.2%)
    Serious Adverse Events
    Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 99/318 (31.1%) 113/329 (34.3%) 111/323 (34.4%)
    Blood and lymphatic system disorders
    Anaemia 1/318 (0.3%) 1/329 (0.3%) 1/323 (0.3%)
    Thrombocytopenia 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Angina pectoris 0/318 (0%) 1/329 (0.3%) 3/323 (0.9%)
    Angina unstable 1/318 (0.3%) 0/329 (0%) 2/323 (0.6%)
    Aortic valve stenosis 2/318 (0.6%) 0/329 (0%) 0/323 (0%)
    Arrhythmia 2/318 (0.6%) 2/329 (0.6%) 0/323 (0%)
    Atrial fibrillation 6/318 (1.9%) 7/329 (2.1%) 2/323 (0.6%)
    Atrioventricular block 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Atrioventricular block complete 2/318 (0.6%) 0/329 (0%) 1/323 (0.3%)
    Atrioventricular block second degree 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Atrioventricular dissociation 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Bradycardia 1/318 (0.3%) 1/329 (0.3%) 2/323 (0.6%)
    Cardiac arrest 4/318 (1.3%) 0/329 (0%) 0/323 (0%)
    Cardiac disorder 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Cardiac failure 0/318 (0%) 0/329 (0%) 2/323 (0.6%)
    Cardiac failure congestive 4/318 (1.3%) 3/329 (0.9%) 8/323 (2.5%)
    Coronary artery disease 2/318 (0.6%) 1/329 (0.3%) 2/323 (0.6%)
    Coronary artery occlusion 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Left ventricular dysfunction 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Left ventricular failure 0/318 (0%) 2/329 (0.6%) 0/323 (0%)
    Mitral valve incompetence 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Mitral valve prolapse 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Myocardial infarction 2/318 (0.6%) 2/329 (0.6%) 1/323 (0.3%)
    Myocardial ischaemia 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Tachycardia 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Ventricular fibrillation 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Ventricular tachycardia 1/318 (0.3%) 2/329 (0.6%) 0/323 (0%)
    Congenital, familial and genetic disorders
    Arteriovenous malformation 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Ear and labyrinth disorders
    Deafness unilateral 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hypoacusis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Vertigo 1/318 (0.3%) 3/329 (0.9%) 0/323 (0%)
    Eye disorders
    Blindness transient 0/318 (0%) 2/329 (0.6%) 2/323 (0.6%)
    Choroidal neovascularisation 1/318 (0.3%) 1/329 (0.3%) 2/323 (0.6%)
    Dry age-related macular degeneration 0/318 (0%) 3/329 (0.9%) 3/323 (0.9%)
    Glaucoma 1/318 (0.3%) 0/329 (0%) 1/323 (0.3%)
    Neovascular age-related macular degeneration 2/318 (0.6%) 1/329 (0.3%) 4/323 (1.2%)
    Open angle glaucoma 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Optic ischaemic neuropathy 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Ulcerative keratitis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Uveitic glaucoma 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Visual acuity reduced 10/318 (3.1%) 13/329 (4%) 18/323 (5.6%)
    Visual impairment 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Vitreous floaters 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Vitreous haemorrhage 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Cataract 1/318 (0.3%) 1/329 (0.3%) 1/323 (0.3%)
    Posterior capsule opacification 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Visual acuity reduced transiently 0/318 (0%) 2/329 (0.6%) 1/323 (0.3%)
    Gastrointestinal disorders
    Abdominal hernia 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Ascites 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Constipation 1/318 (0.3%) 1/329 (0.3%) 1/323 (0.3%)
    Crohn's disease 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Diverticular perforation 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Enteritis 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Gastric ulcer 1/318 (0.3%) 0/329 (0%) 1/323 (0.3%)
    Gastric ulcer haemorrhage 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Gastritis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Gastrointestinal haemorrhage 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Gastrointestinal ulcer haemorrhage 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Incarcerated inguinal hernia 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Intestinal haemorrhage 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Intestinal obstruction 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Lower gastrointestinal haemorrhage 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Obstructive pancreatitis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Pancreatitis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Small intestinal obstruction 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Umbilical hernia 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Upper gastrointestinal haemorrhage 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Volvulus 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    General disorders
    Asthenia 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Chest pain 1/318 (0.3%) 2/329 (0.6%) 0/323 (0%)
    Complication associated with device 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Death 1/318 (0.3%) 3/329 (0.9%) 1/323 (0.3%)
    Systemic inflammatory response syndrome 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Stent-graft endoleak 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hepatobiliary disorders
    Cholecystitis 3/318 (0.9%) 0/329 (0%) 1/323 (0.3%)
    Cholelithiasis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Hepatic cirrhosis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hepatic failure 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Cholecystitis acute 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Infections and infestations
    Bacterial sepsis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Bronchitis 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Cellulitis 1/318 (0.3%) 2/329 (0.6%) 1/323 (0.3%)
    Clostridium difficile colitis 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Cystitis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Diverticulitis 2/318 (0.6%) 1/329 (0.3%) 1/323 (0.3%)
    Endometritis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Endophthalmitis 0/318 (0%) 4/329 (1.2%) 1/323 (0.3%)
    Enterococcal sepsis 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Erysipelas 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Gastroenteritis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Gastroenteritis viral 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Herpes zoster 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Infectious pleural effusion 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Infective exacerbation of chronic obstructive airways disease 0/318 (0%) 0/329 (0%) 2/323 (0.6%)
    Kidney infection 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Localised infection 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Lung infection 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Ophthalmic herpes zoster 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Periorbital cellulitis 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Pharyngitis streptococcal 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Pneumonia 7/318 (2.2%) 3/329 (0.9%) 5/323 (1.5%)
    Pneumonia mycoplasmal 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Pyelonephritis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Sepsis 3/318 (0.9%) 3/329 (0.9%) 1/323 (0.3%)
    Upper respiratory tract infection 1/318 (0.3%) 2/329 (0.6%) 0/323 (0%)
    Urinary tract infection 0/318 (0%) 0/329 (0%) 3/323 (0.9%)
    Urosepsis 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Vaginal infection 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Device related infection 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Lower respiratory tract infection 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Respiratory tract infection 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Injury, poisoning and procedural complications
    Accidental overdose 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Acetabulum fracture 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Ankle fracture 2/318 (0.6%) 1/329 (0.3%) 0/323 (0%)
    Comminuted fracture 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Fall 5/318 (1.6%) 4/329 (1.2%) 5/323 (1.5%)
    Femoral neck fracture 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Femur fracture 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Foot fracture 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Forearm fracture 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Fracture displacement 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Head injury 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Hip fracture 2/318 (0.6%) 1/329 (0.3%) 2/323 (0.6%)
    Humerus fracture 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Incarcerated incisional hernia 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Incomplete spinal fusion 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Laceration 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Lumbar vertebral fracture 0/318 (0%) 2/329 (0.6%) 0/323 (0%)
    Patella fracture 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Pelvic fracture 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Post procedural complication 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Pubis fracture 3/318 (0.9%) 2/329 (0.6%) 0/323 (0%)
    Radius fracture 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Rib fracture 1/318 (0.3%) 0/329 (0%) 1/323 (0.3%)
    Spinal compression fracture 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Sternal fracture 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Subarachnoid haemorrhage 1/318 (0.3%) 1/329 (0.3%) 1/323 (0.3%)
    Subdural haemorrhage 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Tendon rupture 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Traumatic intracranial haemorrhage 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Upper limb fracture 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Wrist fracture 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Brain herniation 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Corneal abrasion 0/318 (0%) 1/329 (0.3%) 2/323 (0.6%)
    Investigations
    Electrocardiogram QT prolonged 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Haemoglobin decreased 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    International normalised ratio abnormal 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Intraocular pressure increased 1/318 (0.3%) 10/329 (3%) 8/323 (2.5%)
    Metabolism and nutrition disorders
    Dehydration 1/318 (0.3%) 2/329 (0.6%) 2/323 (0.6%)
    Failure to thrive 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Fluid overload 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Gout 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hypoglycaemia 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hyponatraemia 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Hypovolaemia 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/318 (0.3%) 2/329 (0.6%) 2/323 (0.6%)
    Costochondritis 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Joint swelling 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Lumbar spinal stenosis 2/318 (0.6%) 0/329 (0%) 1/323 (0.3%)
    Musculoskeletal chest pain 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Osteoarthritis 4/318 (1.3%) 0/329 (0%) 1/323 (0.3%)
    Pain in extremity 1/318 (0.3%) 0/329 (0%) 1/323 (0.3%)
    Rotator cuff syndrome 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Spinal column stenosis 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Spondylolisthesis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Bone cancer 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Breast cancer 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Breast cancer metastatic 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Cervix carcinoma stage IV 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Colon cancer 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Colon neoplasm 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Gastric cancer 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hepatic cancer 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Invasive ductal breast carcinoma 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Laryngeal cancer stage I 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Lip squamous cell carcinoma 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Lung adenocarcinoma 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Lung cancer metastatic 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Lung neoplasm malignant 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Lymphoma 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Malignant neoplasm of unknown primary site 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Metastases to central nervous system 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Neoplasm malignant 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Oesophageal cancer metastatic 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Pancreatic carcinoma 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Prostate cancer 0/318 (0%) 1/329 (0.3%) 2/323 (0.6%)
    Renal cell carcinoma 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Salivary gland neoplasm 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Small intestine carcinoma metastatic 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Squamous cell carcinoma 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Squamous cell carcinoma of the vulva 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Transitional cell carcinoma 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Vulval cancer stage 0 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Waldenstrom's macroglobulinaemia 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Nervous system disorders
    Ataxia 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Balance disorder 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Carotid artery disease 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Carotid artery stenosis 1/318 (0.3%) 0/329 (0%) 1/323 (0.3%)
    Cerebral haemorrhage 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Cerebral infarction 1/318 (0.3%) 0/329 (0%) 1/323 (0.3%)
    Cerebral ischaemia 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Cerebrovascular accident 2/318 (0.6%) 2/329 (0.6%) 1/323 (0.3%)
    Coma 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Dementia 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Dizziness 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Encephalopathy 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Haemorrhagic stroke 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hepatic encephalopathy 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    IIIrd nerve paralysis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Ischaemic stroke 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Lumbar radiculopathy 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Memory impairment 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Metabolic encephalopathy 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Presyncope 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Seizure 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Syncope 2/318 (0.6%) 6/329 (1.8%) 1/323 (0.3%)
    Transient ischaemic attack 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Tremor 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Product Issues
    Device malfunction 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Psychiatric disorders
    Bipolar disorder 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Mental disorder 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Renal and urinary disorders
    Acute kidney injury 1/318 (0.3%) 0/329 (0%) 2/323 (0.6%)
    Bladder cyst 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Lower urinary tract symptoms 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Nephrolithiasis 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Pollakiuria 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Renal colic 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Endometrial hyperplasia 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Prostatomegaly 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/318 (0%) 2/329 (0.6%) 1/323 (0.3%)
    Chronic obstructive pulmonary disease 1/318 (0.3%) 7/329 (2.1%) 1/323 (0.3%)
    Chronic respiratory failure 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Dyspnoea 0/318 (0%) 0/329 (0%) 2/323 (0.6%)
    Haemoptysis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hypoxia 0/318 (0%) 2/329 (0.6%) 0/323 (0%)
    Interstitial lung disease 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Pleural effusion 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Pneumonia aspiration 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Pneumothorax 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Pulmonary embolism 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Pulmonary hypertension 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Respiratory failure 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Sinus polyp 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Skin and subcutaneous tissue disorders
    Skin necrosis 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Surgical and medical procedures
    Fracture treatment 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Vascular disorders
    Aortic aneurysm 0/318 (0%) 2/329 (0.6%) 0/323 (0%)
    Aortic stenosis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Circulatory collapse 1/318 (0.3%) 0/329 (0%) 0/323 (0%)
    Deep vein thrombosis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Hypotension 0/318 (0%) 1/329 (0.3%) 1/323 (0.3%)
    Orthostatic hypotension 1/318 (0.3%) 1/329 (0.3%) 0/323 (0%)
    Peripheral arterial occlusive disease 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Peripheral artery stenosis 0/318 (0%) 1/329 (0.3%) 0/323 (0%)
    Vasculitis 0/318 (0%) 0/329 (0%) 1/323 (0.3%)
    Hypertension 0/318 (0%) 1/329 (0.3%) 2/323 (0.6%)
    Other (Not Including Serious) Adverse Events
    Sham Comparator Lampalizumab Q4W Lampalizumab Q6W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 227/318 (71.4%) 268/329 (81.5%) 253/323 (78.3%)
    Eye disorders
    Conjunctival haemorrhage 84/318 (26.4%) 112/329 (34%) 97/323 (30%)
    Eye pain 30/318 (9.4%) 55/329 (16.7%) 36/323 (11.1%)
    Vitreous detachment 24/318 (7.5%) 37/329 (11.2%) 31/323 (9.6%)
    Cataract 25/318 (7.9%) 23/329 (7%) 25/323 (7.7%)
    Retinal haemorrhage 14/318 (4.4%) 24/329 (7.3%) 22/323 (6.8%)
    Dry eye 16/318 (5%) 19/329 (5.8%) 16/323 (5%)
    Vitreous floaters 5/318 (1.6%) 29/329 (8.8%) 26/323 (8%)
    Blepharitis 11/318 (3.5%) 26/329 (7.9%) 15/323 (4.6%)
    Vision blurred 15/318 (4.7%) 18/329 (5.5%) 12/323 (3.7%)
    Posterior capsule opacification 11/318 (3.5%) 20/329 (6.1%) 11/323 (3.4%)
    Gastrointestinal disorders
    Diarrhoea 5/318 (1.6%) 18/329 (5.5%) 8/323 (2.5%)
    Infections and infestations
    Nasopharyngitis 46/318 (14.5%) 45/329 (13.7%) 36/323 (11.1%)
    Urinary tract infection 22/318 (6.9%) 33/329 (10%) 14/323 (4.3%)
    Bronchitis 16/318 (5%) 25/329 (7.6%) 32/323 (9.9%)
    Upper respiratory tract infection 20/318 (6.3%) 19/329 (5.8%) 13/323 (4%)
    Influenza 13/318 (4.1%) 23/329 (7%) 14/323 (4.3%)
    Injury, poisoning and procedural complications
    Fall 41/318 (12.9%) 47/329 (14.3%) 28/323 (8.7%)
    Investigations
    Intraocular pressure increased 7/318 (2.2%) 50/329 (15.2%) 39/323 (12.1%)
    Musculoskeletal and connective tissue disorders
    Back pain 17/318 (5.3%) 22/329 (6.7%) 14/323 (4.3%)
    Arthralgia 16/318 (5%) 18/329 (5.5%) 14/323 (4.3%)
    Nervous system disorders
    Headache 11/318 (3.5%) 20/329 (6.1%) 9/323 (2.8%)
    Respiratory, thoracic and mediastinal disorders
    Cough 10/318 (3.1%) 26/329 (7.9%) 10/323 (3.1%)
    Vascular disorders
    Hypertension 26/318 (8.2%) 27/329 (8.2%) 22/323 (6.8%)

    Limitations/Caveats

    This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, not all participants in this study completed the full duration of treatment.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the overall study. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800 821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02247531
    Other Study ID Numbers:
    • GX29185
    • 2014-000106-35
    First Posted:
    Sep 25, 2014
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Oct 1, 2019