COMINO: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04740931
Collaborator
Chugai Pharmaceutical (Industry)
730
194
2
28.4
3.8
0.1

Study Details

Study Description

Brief Summary

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
730 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Actual Study Start Date :
Mar 2, 2021
Anticipated Primary Completion Date :
Aug 11, 2022
Anticipated Study Completion Date :
Jul 13, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)

In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

Drug: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Other Names:
  • RG7716
  • RO6867461
  • Procedure: Sham Procedure
    The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

    Active Comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)

    In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).

    Drug: Faricimab
    Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
    Other Names:
  • RG7716
  • RO6867461
  • Drug: Aflibercept
    Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
    Other Names:
  • Eylea
  • Procedure: Sham Procedure
    The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24 [Baseline and Week 24]

    Secondary Outcome Measures

    1. Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    2. Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24 [Baseline and Week 24]

    3. Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    4. Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    5. Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    6. Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    7. Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    8. Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    9. Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    10. Part 1: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    11. Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    12. Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    13. Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    14. Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    15. Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

    16. Part 2: Change from Baseline in BCVA at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    17. Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 72 [Baseline and Week 72]

    18. Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    19. Part 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    20. Part 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    21. Part 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    22. Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    23. Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    24. Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    25. Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    26. Part 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    27. Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    28. Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    29. Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    30. Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    31. Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    32. Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    33. Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

    34. Part 2: Percentage of Participants on Different Treatment Intervals at Week 72 [Week 72]

    35. Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72 [From Week 24 to Week 72]

    36. Part 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    37. Part 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

    38. Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [From Baseline until end of study (up to 72 weeks)]

    39. Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [From Baseline until end of study (up to 72 weeks)]

    40. Plasma Concentration of Faricimab Over Time [Predose at Day 1, Weeks 4, 24, 28, 52, and 72]

    41. Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study [Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), diagnosed no longer than 4 months prior to the screening visit

    • Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent)

    • Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis

    • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment

    Exclusion Criteria:
    • Any major illness or major surgical procedure within 1 month before screening

    • Uncontrolled blood pressure

    • Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1

    • Pregnant or breastfeeding, or intending to become pregnant during the study

    Ocular Exclusion Criteria for Study Eye:
    • History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening

    • Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)

    • Macular laser (focal/grid) in the study eye at any time prior to Day 1

    • Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1

    • Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection

    • Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy

    • Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

    Ocular Exclusion Criteria for Both Eyes:
    • Prior IVT administration of faricimab in either eye

    • History of idiopathic or autoimmune-associated uveitis in either eye

    • Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barnet Dulaney Perkins Eye Center Mesa Arizona United States 85206
    2 Retinal Research Institute, LLC Phoenix Arizona United States 85014
    3 Retina Associates Southwest PC Tucson Arizona United States 85704
    4 Retinal Diagnostic Center Campbell California United States 95008
    5 The Retina Partners Encino California United States 91436
    6 Retina Consultants of Orange County Fullerton California United States 92835
    7 Northern California Retina Vitreous Associates Mountain View California United States 94040
    8 East Bay Retina Consultants Oakland California United States 94609
    9 California Eye Specialists Medical group Inc. Pasadena California United States 91107
    10 Retina Consultants, San Diego Poway California United States 92064
    11 West Coast Retina Medical Group San Francisco California United States 94109
    12 Retina Consultants of Southern Colorado PC Colorado Springs Colorado United States 80909
    13 Colorado Retina Associates, PC Lakewood Colorado United States 80228
    14 Retina Group of New England Waterford Connecticut United States 06385
    15 Advanced Research Coral Springs Florida United States 33067
    16 Rand Eye Deerfield Beach Florida United States 33064
    17 Florida Eye Associates Melbourne Florida United States 32901
    18 Fort Lauderdale Eye Institute Plantation Florida United States 33324
    19 Retina Vitreous Assoc of FL Saint Petersburg Florida United States 33711
    20 Retina Associates of Florida, LLC Tampa Florida United States 33609
    21 Southeast Retina Center Augusta Georgia United States 30909
    22 Georgia Retina PC Marietta Georgia United States 30060
    23 Retina Consultants of Hawaii 'Aiea Hawaii United States 96701
    24 Northwestern Medical Group/Northwestern University Chicago Illinois United States 60611
    25 Retina Associated Ltd Elmhurst Illinois United States 60126
    26 University Retina and Macula Associates, PC Lemont Illinois United States 60439
    27 Prairie Retina Center Springfield Illinois United States 62704
    28 Retina Associates Lenexa Kansas United States 66215
    29 Maine Eye Center Portland Maine United States 04101
    30 Johns Hopkins Med; Wilmer Eye Inst Baltimore Maryland United States 21287
    31 Retina Group of Washington Chevy Chase Maryland United States 20815
    32 Cumberland Valley Retina PC Hagerstown Maryland United States 21740
    33 Assoc Retinal Consultants PC Royal Oak Michigan United States 48073
    34 VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota Edina Minnesota United States 55435
    35 Midwest Vision Research Foundation Chesterfield Missouri United States 63017
    36 Sierra Eye Associates Reno Nevada United States 89502
    37 Mid Atlantic Retina - Wills Eye Hospital Cherry Hill New Jersey United States 08034
    38 Long Is. Vitreoretinal Consult Great Neck New York United States 11021
    39 Retina Vit Surgeons/Central NY Liverpool New York United States 13088
    40 Retina Assoc of Western NY Rochester New York United States 14620
    41 Cincinnati Eye Institute Cincinnati Ohio United States 45242
    42 Cascade Medical Research Institute LLC Eugene Oregon United States 97401
    43 Retina Northwest Portland Oregon United States 97221
    44 Palmetto Retina Center Florence South Carolina United States 29501
    45 Charleston Neuroscience Institute Ladson South Carolina United States 29456
    46 Black Hills Eye Institute Rapid City South Dakota United States 57701
    47 Charles Retina Institute Memphis Tennessee United States 38119
    48 Tennessee Retina PC Nashville Tennessee United States 37203
    49 Retina Res Institute of Texas Abilene Texas United States 79606
    50 Austin Retina Associates Austin Texas United States 78705
    51 Austin Clinical Research LLC Austin Texas United States 78750
    52 Retina Consultants of Texas Bellaire Texas United States 77401
    53 Texas Retina Associates Dallas Texas United States 75231
    54 Retina & Vitreous of Texas Houston Texas United States 77025
    55 Strategic Clinical Research Group, LLC Willow Park Texas United States 76087
    56 Retina Associates of Utah Salt Lake City Utah United States 84107
    57 Piedmont Eye Center Lynchburg Virginia United States 24502
    58 West Virginia University Eye Institute Morgantown West Virginia United States 26506
    59 Organizacion Medica de Investigacion Buenos Aires Argentina C1015ABO
    60 Fundacion Zambrano Caba Argentina C1017AAO
    61 Centro Oftalmológico Dr. Charles S.A. Capital Federal Argentina C1015ABO
    62 Oftalmos Capital Federal Argentina C1120AAN
    63 Hospital Italiano; Ophtalmology Capital Federal Argentina C1199ABC
    64 Buenos Aires Mácula Ciudad Autonoma Buenos Aires Argentina C1061AAE
    65 Oftar Mendoza Argentina M5500GGK
    66 Centro Oftalmólogos Especialistas Rosario Argentina S2000ANJ
    67 Grupo Laser Vision Rosario Argentina S2000DLA
    68 Eyeclinic Albury Wodonga Albury New South Wales Australia 2640
    69 Strathfield Retina Clinic Strathfield New South Wales Australia 2135
    70 Save Sight Institute Sydney New South Wales Australia 2000
    71 Sydney Retina Clinic and Day Surgery Sydney New South Wales Australia 2000
    72 Centre For Eye Research Australia East Melbourne Victoria Australia 3002
    73 Retina Specialists Victoria Rowville Victoria Australia 3178
    74 The Lions Eye Institute Nedlands Western Australia Australia 6009
    75 LKH-Univ.Klinikum Graz; Universitäts-Augenklinik Graz Austria 8036
    76 Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie Wien Austria 1090
    77 Hospital de Olhos de Aparecida - HOA Aparecida de Goiania GO Brazil 74980-010
    78 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
    79 Botelho Hospital da Visao Blumenau SC Brazil 89052-504
    80 Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia Sao Paulo SP Brazil 04023-062
    81 Hosp de Olhos de Sorocaba Sorocaba SP Brazil 18031-060
    82 Beijing Hospital of Ministry of Health Beijing China 100730
    83 The Second Hospital of Jilin University Changchun China 130041
    84 West China Hospital, Sichuan University Chengdu China 610041
    85 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou City China 510060
    86 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou City China 310009
    87 The 2nd Affiliated Hospital of Harbin Medical University Harbin China 150001
    88 Shanghai Tenth People's Hospital Shanghai China 200072
    89 Shanghai First People's Hospital Shanghai China 200080
    90 He Eye Specialist Shenyang Hospital Shenyang City China 110034
    91 Tianjin Eye Hospital Tianjin City China 300050
    92 Tianjin Medical University Eye Hospital Tianjin City China 300070
    93 Eye Hospital, Wenzhou Medical University Wenzhou City China 325027
    94 Renmin Hospital of Wuhan University Wuhan China 430060
    95 Henan Provincial Eye Hosptial Zhengzhou China
    96 General Teaching Hospital Prague; Ophthalmology clinic Prague Czechia 128 08
    97 AXON Clinical Prague Czechia
    98 Chi De Creteil; Ophtalmologie Creteil France 94010
    99 Hopital Lariboisiere; Ophtalmologie Paris France 75010
    100 Centre Ophtalmologique; Imagerie et laser Paris France 75015
    101 Centres Ophtalmologique St Exupéry; Ophtalmologie St Cyr Sur Loire France 37540
    102 Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe Düsseldorf-Oberkassel Germany 40549
    103 Universitätsklinikum Freiburg, Klinik für Augenheilkunde Freiburg Germany 79106
    104 Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik Ludwigshafen Germany 67063
    105 Queen Mary Hospital; Department of Ophthalmology Hong Kong Hong Kong
    106 Hong Kong Eye Hospital; CUHK Eye Centre Mongkok Hong Kong
    107 Bajcsy-Zsilinszky Hospital Budapest Hungary 1106
    108 Budapest Retina Associates Kft. Budapest Hungary 1133
    109 Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika Debrecen Hungary 4032
    110 Szegedi Tudományegyetem ÁOK; Department of Ophtalmology Szeged Hungary 6720
    111 Zala Megyei Kórház; SZEMESZET Zalaegerszeg Hungary 8900
    112 Rambam Medical Center; Opthalmology Haifa Israel 3109601
    113 Hadassah MC; Ophtalmology Jerusalem Israel 9112001
    114 Rabin MC; Ophtalmology Petach Tikva Israel 4941492
    115 Kaplan Medical Center; Ophtalmology Rehovot Israel 7660101
    116 Tel Aviv Sourasky MC; Ophtalmology Tel Aviv Israel 6423906
    117 Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico Roma Lazio Italy 00198
    118 Irccs Ospedale San Raffaele;U.O. Oculistica Milano Lombardia Italy 20132
    119 Sugita Eye Hospital Aichi Japan 460-0008
    120 Nagoya University Hospital Aichi Japan 466-8560
    121 Nagoya City University Hospital Aichi Japan 467-8602
    122 Aichi Medical University Hospital Aichi Japan 480-1195
    123 Toho University Sakura Medical Center Chiba Japan 285-8741
    124 Hayashi Eye Hospital Fukuoka Japan 812-0011
    125 Kurume University Hospital Fukuoka Japan 830-0011
    126 Fukushima Medical University Hospital Fukushima Japan 960-1295
    127 Asahikawa Medical University Hospital Hokkaido Japan 078-8510
    128 Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) Hyogo Japan 660-8550
    129 Hyogo Medical University Hospital Hyogo Japan 663-8501
    130 Kozawa eye hospital and diabetes center Ibaraki Japan 310-0845
    131 Kagawa University Hospital Kagawa Japan 761-0793
    132 Kagoshima University Hospital Kagoshima Japan 890-8520
    133 Mie University Hospital Mie Japan 514-8507
    134 Shinshu University Hospital Nagano Japan 390-8621
    135 Osaka Metropolitan University Hospital Osaka Japan 545-8586
    136 Kansai Medical University Medical Center Osaka Japan 570-8507
    137 Tokyo Women's Medical University Hospital Tokyo Japan 162-8666
    138 Tokyo Medical University Hachioji Medical Center Tokyo Japan 193-0998
    139 Pusan National University Hospital Busan Korea, Republic of 49241
    140 Yeungnam University Medical Center Daegu Korea, Republic of 42415
    141 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
    142 Kyung Hee University Hospital Seoul Korea, Republic of 02447
    143 Seoul National University Hospital Seoul Korea, Republic of 03080
    144 Asan Medical Center Seoul Korea, Republic of 05505
    145 Samsung Medical Center Seoul Korea, Republic of 06351
    146 Kim's Eye Hospital Seoul Korea, Republic of 07301
    147 Szpital sw. Lukasza Bielsko-Biala Poland 43-309
    148 OFTALMIKA Sp. z o.o Bydgoszcz Poland 85-631
    149 Specjalistyczny Ośrodek Okulistyczny Oculomedica Bydgoszcz Poland 85-870
    150 Szpital Specjalistyczny nr 1; Oddzial Okulistyki Bytom Poland 41-902
    151 Dobry Wzrok Sp Z O O Gdańsk Poland 80-402
    152 Optimum Profesorskie Centrum Okulistyki Gdańsk Poland 80-809
    153 Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT Gliwice Poland 44-100
    154 Gabinet Okulistyczny Prof Edward Wylegala Katowice Poland 40-594
    155 SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej Krakow Poland 31-501
    156 Centrum Medyczne Dietla 19 Sp. Z O.O. Kraków Poland 31-070
    157 MT Medic Krosno Krosno Poland 38-400
    158 Ośrodek Chirurgii Oka Prof. Zagórskiego Nałęczów Nałęczów Poland 24-140
    159 Centrum Medyczne Pulawska SP. z o.o. Piaseczno Poland 05-500
    160 Lens Clinic Rybnik Poland 44-203
    161 Caminomed Tarnowskie Góry Poland 42-600
    162 Centrum Zdrowia MDM Warszawa Poland 00-631
    163 SPEKTRUM Osrodek Okulistyki Klinicznej Wroclaw Poland 53-334
    164 Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia Coimbra Portugal 3000-075
    165 Espaco Medico Coimbra Coimbra Portugal 3030-163
    166 Hospital de Santa Maria; Servico de Oftalmologia Lisboa Portugal 1649-035
    167 Clinic Optimed UFA Baskortostan Russian Federation 450059
    168 Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch Cheboksary Marij EL Russian Federation 428000
    169 FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences Moscow Russian Federation 119435
    170 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology Saint Petersburg Russian Federation 197022
    171 Medical Military Academy n.a S.M.Kirov St.Petersburg Russian Federation 194044
    172 Singapore Eye Research Institute Singapore Singapore 168751
    173 Tan Tock Seng Hospital; Ophthalmology Department Singapore Singapore 308433
    174 Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
    175 Hospital General de Catalunya San Cugat Del Valles Barcelona Spain 08195
    176 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
    177 Complejo Hospitalario de Navarra; Servicio de oftalmologia Pamplona Navarra Spain 31008
    178 Centro de Oftalmologia Barraquer; Servicio Oftalmologia Barcelona Spain 08021
    179 Hospital Clinic de Barcelona; Consultas Externas Oftalmologia Barcelona Spain 08028
    180 Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia Barcelona Spain 08041
    181 Hospital Universitario Rio Hortega; Servicio de Oftalmologia Valladolid Spain 47012
    182 Changhua Christian Hospital; Department of Ophthalmology Changhua Taiwan 500
    183 Taipei Veterans General Hospital; Ophthalmology Taipei Taiwan 11217
    184 Chang Gung Medical Foundation - Linkou; Ophthalmology Taoyuan Taiwan 333
    185 Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL Belfast United Kingdom BT12 6BA
    186 Birmingham Midland Eye Centre Birmingham United Kingdom B18 7QH
    187 Opthalmology Research Office Bradford United Kingdom BD9 6RJ
    188 Bristol Eye Hospital;Retinal Treatment and Research Unit Bristol United Kingdom BS1 2LX
    189 University Hospital of Wales Cardiff United Kingdom CF14 4XW
    190 St James University Hospital Leeds United Kingdom LS9 7TF
    191 Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre Liverpool United Kingdom L7 8XP
    192 Central Middlesex Hospital London United Kingdom NW10 7NS
    193 Maidstone and Tunbridge Wells NHS Trust Maidstone United Kingdom ME16 9QQ
    194 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP

    Sponsors and Collaborators

    • Hoffmann-La Roche
    • Chugai Pharmaceutical

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04740931
    Other Study ID Numbers:
    • GR41986
    • 2020-000441-13
    First Posted:
    Feb 5, 2021
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hoffmann-La Roche
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 26, 2022