Actively Recruiting
A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio
Led by Apellis Pharmaceuticals, Inc. · Updated on 2026-03-30
240
Participants Needed
43
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 2, Randomized, Placebo-controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL-3007 in Combination with Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed with Geographic Atrophy Secondary to Age-Related Macular Degeneration
CONDITIONS
Official Title
A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Study eye must meet all inclusion criteria; if both eyes qualify, the eye with better visual acuity at screening will be the study eye
- Aged 60 years or older
- Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration in one or both eyes confirmed by reading center
- Normal luminance best corrected visual acuity (NL-BCVA) of 50 letters or better on ETDRS charts
- Adequate ocular media clarity, pupillary dilation, and fixation for quality imaging
- Prior Syfovre treatment in the study eye at 6-8 week intervals for at least 6 months but no more than 24 months, with at least 2 injections in the last 6 months
- GA lesion in study eye with total area between 2.5 and 17.5 mm2, with specific lesion size and location criteria confirmed by central reading center
- Presence of any hyperautofluorescence pattern in the junctional zone of GA on FAF imaging
- Documented vaccination within 5 years or willingness to initiate vaccinations at least 14 days prior to dosing against specified bacteria
- Women must be non-childbearing or use contraception with negative pregnancy test; men must be surgically sterile or use contraception
- Willing and able to provide informed consent and adhere to study schedule
You will not qualify if you...
- Uncontrolled or clinically relevant history of major systemic diseases or cancer
- History or presence of liver disease increasing risk of drug-induced liver injury
- History or presence of systemic autoimmune disorders except well-controlled Hashimoto's thyroiditis
- Allergy or serious reaction to siRNA therapy or study drug components
- Clinically meaningful cardiac, hepatic, or renal abnormalities on diagnostic testing
- History or presence of malignancy except skin basal or squamous cell carcinoma treated over 1 year ago
- History or presence of recurrent infections or certain viral infections including HIV, hepatitis B and C
- Fever or acute infection including COVID-19 within 30 days before dosing
- Evidence of drug or alcohol abuse
- Intention to donate sperm during study or within 90 days after last dose
- Prior administration of APL-3007
- Participation in other investigational product or device study within 5 half-lives before screening
- Poor peripheral venous access or skin conditions interfering with injections
- Any condition or treatment interfering with study conduct or increasing risk
- Live vaccination within 30 days before first dose except seasonal flu
- Pregnancy or breastfeeding
- Medical or psychiatric conditions limiting study compliance or safety
- Ocular exclusions specific to study eye including GA from other causes, history of CNV or neovascularization, active ocular diseases impairing vision, recent IVT injections except Syfovre, prior investigational GA treatments within 3 months, laser therapy in macula, or ocular conditions requiring surgery or intervention during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 43 locations
1
Barnet Dulaney Perkins Eye Center (01018)
Mesa, Arizona, United States, 85206
Actively Recruiting
2
Associated Retina Consultants - Phoenix
Phoenix, Arizona, United States, 85020
Actively Recruiting
3
Retinal Research Institute, LLC (01021)
Phoenix, Arizona, United States, 85053
Actively Recruiting
4
California Retina Consultants (CRC) - Bakersfield Office
Bakersfield, California, United States, 93309
Actively Recruiting
5
The Retina Partners - Encino
Encino, California, United States, 07003
Actively Recruiting
6
Retina Consultants of Orange County - Fullerton Office
Fullerton, California, United States, 93825
Actively Recruiting
7
Salehi Retina Institute, Inc dba Retina Associate or Southern California (01034)
Huntington Beach, California, United States, 92647
Actively Recruiting
8
Retina Consultants San Diego
Poway, California, United States, 92064
Actively Recruiting
9
Orange County Retina Medical Group
Santa Ana, California, United States, 92705
Actively Recruiting
10
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States, 94598
Actively Recruiting
11
Colorado Retina Associates, PLLC
Lakewood, Colorado, United States, 80228
Actively Recruiting
12
Advanced Vision Research Institute
Longmont, Colorado, United States, 80503
Actively Recruiting
13
Florida Retina Institute - Orlando (01053)
Orlando, Florida, United States, 32806
Actively Recruiting
14
Retina Specialty Institute - Pensacola
Pensacola, Florida, United States, 32503
Actively Recruiting
15
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
St. Petersburg, Florida, United States, 33711
Actively Recruiting
16
Center for Retina and Macular Disease (01026)
Winter Haven, Florida, United States, 33880
Actively Recruiting
17
Southeast Retina Center
Augusta, Georgia, United States, 30909
Actively Recruiting
18
Illinois Retina Associates, S.C. - Oak Park (01061)
Oak Park, Illinois, United States, 60304
Actively Recruiting
19
Retina Consultants P.C.
Indianapolis, Indiana, United States, 46214
Actively Recruiting
20
Retina Associates New Orleans - Jefferson Parish Location
Metairie, Louisiana, United States, 70001
Actively Recruiting
21
Cumberland Valley Retina Consultants (CVRC)
Hagerstown, Maryland, United States, 21740
Actively Recruiting
22
Mississippi Retina Associates
Madison, Mississippi, United States, 39110
Actively Recruiting
23
Long Island Vitreoretinal Consultants - Westbury
Long Island City, New York, United States, 11590
Actively Recruiting
24
Retina Assocaites of Cleveland, Inc (01048)
Cleveland, Ohio, United States, 44122
Actively Recruiting
25
Verum Research, LLC
Eugene, Oregon, United States, 97401
Actively Recruiting
26
EyeHealth Northwest
Portland, Oregon, United States, 97225
Actively Recruiting
27
Mid Atlantic Retina - Philadelphia (01017)
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
28
Charleston Neuroscience Institute LLC - Ladson
Ladson, South Carolina, United States, 29456
Actively Recruiting
29
Charleston Neuroscience Institute, LLC - Mount Pleasant (01051)
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
30
Retina Consultants of Texas - Abilene (01035)
Abilene, Texas, United States, 79606
Actively Recruiting
31
Austin Retina Associates
Austin, Texas, United States, 78705
Actively Recruiting
32
Retina Consultants of Texas - Bellaire (01067)
Bellaire, Texas, United States, 77401
Actively Recruiting
33
Texas Retina Associates
Dallas, Texas, United States, 75231
Actively Recruiting
34
Retina Consultants of Texas - Katy
Katy, Texas, United States, 77494
Actively Recruiting
35
Valley Retina Institute- McAllen (01076)
McAllen, Texas, United States, 78503
Actively Recruiting
36
Austin Retina Associates - Round Rock (01032)
Round Rock, Texas, United States, 78681
Actively Recruiting
37
Retina Consultants of Texas - San Antonio Medical Center
San Antonio, Texas, United States, 78240
Actively Recruiting
38
Austin Retina Associate (01046)
San Marcos, Texas, United States, 78666
Actively Recruiting
39
Retina Consultants of Texas (01055)
Schertz, Texas, United States, 78154
Actively Recruiting
40
Retina Center of Texas - Southlake
Southlake, Texas, United States, 76092
Actively Recruiting
41
Retina Consultants of Texas - The Woodlands
The Woodlands, Texas, United States, 73384
Actively Recruiting
42
Tyler Retina Consultants
Tyler, Texas, United States, 75703
Actively Recruiting
43
University of Wisconsin Health - University Station Clinic
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
A
Apellis Clinical Trial Information Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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