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Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration

Sponsor
Apellis Pharmaceuticals, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03525600
Collaborator
(none)
600
Enrollment
141
Locations
4
Arms
53
Anticipated Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Actual Study Start Date :
Aug 31, 2018
Actual Primary Completion Date :
Jun 21, 2021
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: APL-2 15mg 0.1 mL monthly for 24 months

A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every month

Drug: APL-2
Complement (C3) Inhibitor
Experimental: APL-2 15mg 0.1 mL EOM for 24 months

A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month

Drug: APL-2
Complement (C3) Inhibitor
Experimental: Sham Procedure Monthly for 24 months

Sham Procedure for 24 months

Other: Sham Procedure
Subjects will receive a Sham procedure every month
Experimental: Sham Procedure Every Other Month for 24 months

Sham Procedure every other month for 24 months

Other: Sham Procedure
Subjects will receive a Sham procedure every other month

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline to Month 12 in total area of GA Lesion(s) in the study eye (in mm2) as Measured by Fundus Autofluorescence (FAF) [Baseline, 12 months]

Secondary Outcome Measures

  1. Incidence and severity of ocular and systemic treatment-emergent adverse events. [30 months]

Eligibility Criteria

Criteria

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

The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye.

Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.

  • Age ≥ 60 years.

  • Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).

  • Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.

  • The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:

  • Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)

  • If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 4a.

  • The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.

  • Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.

  • Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.

  • Female subjects must be:

  • Women of non-child-bearing potential (WONCBP), or

  • Women of child-bearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.

  • Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.

  • Willing and able to give informed consent and to comply with the study procedures and assessments.

Exclusion Criteria:

Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.

  • GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.

  • Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.

  • Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.

  • Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane (ERM), full thickness macular hole or uncontrolled glaucoma/ocular hypertension. Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary).

  • Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.

  • History of laser therapy in the macular region.

  • Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.

  • Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.

  • Any contraindication to IVT injection including current ocular or periocular infection.

  • History of prior intravitreal injection.

  • Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).

  • Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.

  • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.

  • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.

  • Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.

  • Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retinal Research Institute Phoenix Arizona United States 85014
2 Associated Retina Consultants, Ltd Phoenix Arizona United States 85020
3 Retina Institute of California dba Acuity Eye Grp Arcadia California United States 91007
4 California Retina Consultants Bakersfield California United States 93309
5 Retina Vitreous Associates Medical Group Beverly Hills California United States 90211
6 The Retina Partners Encino California United States 91436
7 The Gavin Herbert Eye Institute/UC Irvine Irvine California United States 92697
8 Northern California Retina Vitreous Associates Mountain View California United States 94040
9 Retina Institute of California Medical Group Palm Desert California United States 92260
10 Byers Eye Institute at Standford, Stanford School of Medicine Palo Alto California United States 94303
11 Retina Consultants San Diego Poway California United States 92064
12 Retina Consultants of Southern California Redlands California United States 92374
13 California Retina Consultants Santa Barbara California United States 93103
14 Bay Area Retina Associates Walnut Creek California United States 94598
15 Danbury Eye Physicians & Surgeons, P.C. - Danbury Danbury Connecticut United States 06810
16 New England Retina Associates Hamden Connecticut United States 06518
17 Retina Group of New England,PC Waterford Connecticut United States 06385
18 Florida Eye Microsurgical Institute, Inc. Boynton Beach Florida United States 33426
19 Pinnacle Research Institute Fort Lauderdale Florida United States 33309
20 Retina Health Center Fort Myers Florida United States 33907
21 Bascom Palmer Eye Institute Palm Beach Gardens Florida United States 33418
22 Eye Associates of Pinellas Pinellas Park Florida United States 33782
23 East Florida Eye Institute Stuart Florida United States 34994
24 Southern Vitreoretinal Associates Tallahassee Florida United States 32308
25 Retina Associates of Florida Tampa Florida United States 33609
26 University of South Florida (USF) Eye Institute Tampa Florida United States 33612
27 Southeast Retina Center, PC Augusta Georgia United States 30909
28 Georgia Retina Marietta Georgia United States 30060
29 Midwest Eye Institute Indianapolis Indiana United States 46290
30 Sabates Eye Center Leawood Kansas United States 66211
31 Elman Retina Group, PA Baltimore Maryland United States 21236
32 Cumberland Valley Retina Consultants, PC Hagerstown Maryland United States 21740
33 Mid Atlantic Retina Specialists Hagerstown Maryland United States 21740
34 Retina Specialists Towson Maryland United States 21204
35 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114
36 New England Retina Consultants, PC Springfield Massachusetts United States 01107
37 Associated Retinal Consultants, P.C Grand Rapids Michigan United States 49546
38 Retina Specialists of Michigan / Foundation for Vision Grand Rapids Michigan United States 49546
39 Retina Consultants of Michigan Southfield Michigan United States 48034
40 Associated Retinal Consultants PC Traverse City Michigan United States 49686
41 Sierra Eye Associates Reno Nevada United States 89503
42 Retina Associates of New Jersey (NJ Retina) Teaneck New Jersey United States 07666
43 Long Island Vitreoretinal Consultants Great Neck New York United States 11021
44 Vitreous Retina Macula Consultants of NY New York New York United States 10022
45 Western Carolina Retinal Associates Asheville North Carolina United States 28803
46 Charlotte Eye Ear Nose and Throat Associates, PS Charlotte North Carolina United States 28210
47 Graystone Eye Hickory North Carolina United States 28602
48 Retina Associates of Cleveland, Inc. Cleveland Ohio United States 44122
49 Retina Associates of Cleveland, Inc Cleveland Ohio United States 44122
50 Retina Associates of Cleveland Cleveland Ohio United States 44130
51 Cleveland Clinic, Cole Eye Institute Cleveland Ohio United States 44195
52 The Ohio State University Columbus Ohio United States 43212
53 Retina Associates of Cleveland, Inc. Youngstown Ohio United States 44505
54 Retina Northwest, PC Portland Oregon United States 97221
55 Eye Health Northwest Portland Oregon United States 97225
56 Mid Atlantic Retina Philadelphia Pennsylvania United States 19006
57 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
58 Tennessee Retina, PC Nashville Tennessee United States 37203
59 Retina Research Institute of Texas Abilene Texas United States 79606
60 Southwest Retina Specialists Amarillo Texas United States 79106
61 Retina Consultants of Austin (Retina Research Center) Austin Texas United States 78705
62 Retina Consultants of Houston, PA Houston Texas United States 77030
63 Valley Retina Institute, PA McAllen Texas United States 78503
64 Medical Center Ophthalmology Associates San Antonio Texas United States 78240
65 Retinal Consultants of San Antonio San Antonio Texas United States 78240
66 Retina Consultants of Houston The Woodlands Texas United States 77384
67 Retina Associates of Utah, PC Murray Utah United States 84107
68 University of Virginia Charlottesville Virginia United States 22903
69 The Retina Group of Washington Fairfax Virginia United States 22031
70 Virginia Retina Center Warrenton Virginia United States 20186
71 Vitreoretinal Associates of Washington Bellevue Washington United States 98004
72 Spokane Eye Clinical Research Spokane Washington United States 99204
73 University of Wisconsin Madison Wisconsin United States 53715
74 Fundacion Zambrano Buenos Aires Capital Federal Argentina C1023 AAQ
75 Microcirugia Ocular Rosario Corrientes Argentina 2000
76 Grupo Laser Vision Rosario Santa Fe Argentina S2000 AZH
77 Organizacion Medica de investigacion Buenos Aires Argentina C1015 ABO
78 Centro Oftalmologico Dr Charles Buenos Aires Argentina C1116ABA
79 Diagnostico Ocular Buenos Aires Argentina C1425BGE
80 Centro Privado de Ojos Romagosa SA Córdoba Argentina X5000AAJ
81 Instituto Oftalmologico de Cordoba Córdoba Argentina X5000III
82 Oftar Mendoza SRL Mendoza Argentina 5500
83 Oftalmologos Especialistas Rosario Argentina 1288
84 Sydney Retina Sydney New South Wales Australia 2000
85 Centre for Eye Research Australia East Melbourne Victoria Australia 3002
86 Retina and Eye Consultants Hurstville Australia NSW 2220
87 Clinica Ocular Oftalmologia LTDA Vitória Espirito Santo Brazil 29055-45
88 Clinica Oftalmologica Sao Lucas Osasco Sao Paulo Brazil 06010-130
89 IPEPO - Instituto Da Visao São Paulo Vila Clementino Brazil 04038-032
90 Instituto da Visão - Hospital de Olhos Ltda Belo Horizonte Brazil 32150-274
91 Hospital De Clinicas De Porto Alegre Porto Alegre Brazil 90036-903
92 UNIFESP - Federal University São Paulo Brazil 04021-001
93 Ivey Eye Institute London Ontario Canada N6A
94 University of Ottawa Eye Institute Ottawa Ontario Canada K1H 8L6
95 DRY AMD Clinic - St. Michael's Hospital Toronto Ontario Canada M5C 1R6
96 Retina Centre of Ottawa Ottawa Canada K2B 7E9
97 Fakultní nemocnice Ostrava Ostrava-Poruba Czechia 708 52
98 OFTEX Eye Clinic Pardubice Czechia 53002
99 AXON Clinical, S.R.O. Praha Czechia 150 00
100 University Hospital Kralovske Vinochrady Vinohrady Czechia 100 34
101 Centre Hospitalier Intercommunal de Créteil Créteil France
102 Hopital de la Croix-Rousse Lyon France 69004
103 Centre Monticelli Paradis Marseille France 13008
104 CHU de Nantes - Hotel Dieu Nantes France 44093
105 Centre Ophtalmologique de l´Odéon Paris France 75006
106 Centre Ophthalmologique Saint-Exupery Saint-Cyr-sur-Loire France 37540
107 Maison Rouge Ophthalmologic Center Strasbourg France 67000
108 Universitäts-Augenklinik Bonn Bonn Germany 53127
109 University Hospital Cologne Cologne Germany 50937
110 Klinikum der Stadt Ludwigshafen gGmbH Ludwigshafen Germany 67063
111 Klinikum rechts der Isar München Germany 81675
112 Universitätsklinikum Regensburg Regensburg Germany 93053
113 University Hospital Würzburg Würzburg Germany 97080
114 Shamir Medical Center Be'er Ya'aqov Israel 7030000
115 Rambam Medical Center Haifa Israel 3109601
116 Meir Medical Center Kfar Saba Israel 4428164
117 Rabin Medical Center Petah tikva Israel 49100
118 Kaplan Medical Center Reẖovot Israel 76100
119 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
120 Ospedale San Raffaele Milano Italy 20132
121 Luigi Sacco Hospital Milano Italy 20157
122 Retina Specialist Auckland New Zealand 1052
123 Hamilton Eye Clinic Hamilton New Zealand 3204
124 Oftalmika Eye Hospital Bydgoszcz Poland 85-631
125 Centrum Diagnostyki i Mikrochirurgii Oka - LENS Olsztyn Poland 10-424
126 Centrum Medyczne UNO-MED Tarnow Poland 33-100
127 Jasne Blonia Eye Clinic Łódź Poland 91-134
128 Emanuelli Research and Development Center Arecibo Puerto Rico 00612
129 Centro Médico Teknon Barcelona Spain 08022
130 Instituto Oftalmologico Gómez-Ulla Santiago De Compostela Spain 15706
131 Hospital Universitario Rio Hortega Valladolid Spain 47006
132 Moorfields Eye Hospital NHS Foundation Trust London England United Kingdom EC1V 2PD
133 Eye Clinic, Acre Mill Outpatients, Huddersfield Royal Infirmary Huddersfield West Yorkshire United Kingdom HD3 3EA
134 Bristol Eye Hospital Bristol United Kingdom BS1 2LX
135 St James's University Hospital Leeds United Kingdom LS9 7TF
136 Leicester Royal Infirmary Leicester United Kingdom LEI 5WW
137 London North West University Hospital Trust London United Kingdom NW10 7NS
138 King's College Hospital NHS Trust London United Kingdom SE5 9RS
139 Oxford Eye Hospital Oxford United Kingdom OX3 9DU
140 Salisbury NHS Foundation Trust Salisbury United Kingdom SP2 8BJ
141 Sunderland Eye Infirmary Sunderland United Kingdom SR2 9HP

Sponsors and Collaborators

  • Apellis Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03525600
Other Study ID Numbers:
  • APL2-303
First Posted:
May 15, 2018
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Atrophy

Study Results

No Results Posted as of Jun 22, 2022