Actively Recruiting
A Phase 2, Randomized, Placebo-Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL-3007 Combined With Syfovre/Pegcetacoplan (APL-2) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Led by Apellis Pharmaceuticals, Inc. · Updated on 2026-06-04
240
Participants Needed
68
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in people aged 60 and older who have geographic atrophy caused by age-related macular degeneration. This Phase 2, randomized, placebo-controlled, and masked study aims to evaluate how well this combination works, its safety, tolerability, and how the drugs affect the body. The study is sponsored by Apellis Pharmaceuticals, Inc. and involves multiple medical centers. Participants will be randomly assigned to one of three groups: two experimental groups receiving different doses or frequencies of APL-3007 with pegcetacoplan, and a placebo group receiving placebo injections along with pegcetacoplan. The treatments involve multiple doses over the study period. The study eye will be carefully selected based on vision and lesion characteristics to receive the assigned treatment. During the 12-month study, participants will undergo various assessments including AI-based imaging scans to measure changes in retinal pigment epithelium (RPE) lesions, photoreceptor degeneration, and visual acuity. Safety will be monitored through adverse event reporting and lab tests. Other measures include serum C3 levels and functional vision tests under different lighting conditions. Participants will adhere to the study visit schedule and complete all required evaluations to help researchers understand treatment effects and safety.
CONDITIONS
Brief 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...
- Age 60 years or older
- Clinical diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in one or both eyes
- Study eye must have normal luminance best corrected visual acuity (NL-BCVA) of 50 letters or better using ETDRS charts
- Adequate eye clarity, pupillary dilation, and fixation for quality imaging
- Prior treatment with Syfovre at 6-8 week intervals for at least 6 months and no more than 24 months, with at least 2 injections in the last 6 months
- GA lesion in the study eye must be between 2.5 and 17.5 mm2 in total area with specific size and location requirements
- Presence of any pattern of hyperautofluorescence in the GA junctional zone based on FAF imaging
- Documented vaccination within 5 years against specific bacteria or willingness to initiate vaccinations before dosing
- 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 follow study visits
You will not qualify if you...
- Uncontrolled or clinically relevant history of major systemic diseases including gastrointestinal, renal, hepatic, neurological, psychiatric, cardiovascular, hematological, metabolic disorders, or cancer
- History or presence of liver disease increasing drug injury risk
- Systemic autoimmune disorders except well-controlled Hashimoto's thyroiditis
- Allergy or serious reaction to siRNA therapy or study drug components
- Clinically relevant abnormalities in heart rate, ECG, liver function tests, or kidney function
- History of malignancy not treated successfully within 1 year
- History of recurrent infections or certain viral infections including HIV, hepatitis B or C, meningococcal infection
- Fever or acute infection within 30 days before dosing
- Evidence of drug or alcohol abuse
- Intent to donate sperm during study or 90 days after last dose
- Prior administration of APL-3007
- Participation in other investigational studies recently
- Poor venous access or abnormal skin conditions affecting injections
- Any condition increasing risk or interfering with study conduct
- Recent live vaccinations within 30 days before first dose
- Pregnancy or breastfeeding
- Medical or psychiatric conditions affecting follow-up or safety
- Ocular exclusions including other causes of GA, history of choroidal neovascularization, active ocular diseases affecting vision, recent eye injections except Syfovre, recent investigational treatments, laser therapy in macula, or other ocular conditions needing intervention during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive multiple doses of APL-3007 combined with pegcetacoplan (APL-2) or placebo to evaluate the efficacy, safety, and tolerability of the treatment.
Regular visits over 12 months for dosing and assessments
Trial Site Locations
Total: 68 locations
1
Associated Retina Consultants (01065)
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Barnet Dulaney Perkins Eye Center (01018)
Mesa, Arizona, United States, 85206
Actively Recruiting
3
Associated Retina Consultants - Phoenix
Phoenix, Arizona, United States, 85020
Actively Recruiting
4
Retinal Research Institute, LLC (01021)
Phoenix, Arizona, United States, 85053
Actively Recruiting
5
California Retina Consultants (CRC) - Bakersfield Office
Bakersfield, California, United States, 93309
Actively Recruiting
6
The Retina Partners - Encino
Encino, California, United States, 07003
Actively Recruiting
7
Retina Consultants of Orange County - Fullerton Office
Fullerton, California, United States, 93825
Actively Recruiting
8
Salehi Retina Institute, Inc dba Retina Associate or Southern California (01034)
Huntington Beach, California, United States, 92647
Actively Recruiting
9
Salehi Retina Institute, Inc. Dba Retina Associates of Southern California (01034)
Huntington Beach, California, United States, 92647
Actively Recruiting
10
California Retina Consultants (01054)
Oxnard, California, United States, 93036
Actively Recruiting
11
Retina Consultants San Diego
Poway, California, United States, 92064
Actively Recruiting
12
Orange County Retina Medical Group
Santa Ana, California, United States, 92705
Actively Recruiting
13
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States, 94598
Actively Recruiting
14
Colorado Retina Associates, PLLC
Lakewood, Colorado, United States, 80228
Actively Recruiting
15
Advanced Vision Research Institute
Longmont, Colorado, United States, 80503
Actively Recruiting
16
Connecticut Eye Consultants, PC (01074)
Danbury, Connecticut, United States, 06810
Actively Recruiting
17
ClearVista Clinical Research, LLC (01096)
Bayonet Point, Florida, United States, 34667
Actively Recruiting
18
Florida Retina Institute (01053)
Orlando, Florida, United States, 32806
Actively Recruiting
19
Florida Retina Institute - Orlando (01053)
Orlando, Florida, United States, 32806
Actively Recruiting
20
Retina Specialty Institute - Pensacola
Pensacola, Florida, United States, 32503
Actively Recruiting
21
Eye Associates of Pinellas (01020)
Pinellas Park, Florida, United States, 33782
Actively Recruiting
22
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
St. Petersburg, Florida, United States, 33711
Actively Recruiting
23
Center for Retina and Macular Disease (01026)
Winter Haven, Florida, United States, 33880
Actively Recruiting
24
Southeast Retina Center
Augusta, Georgia, United States, 30909
Actively Recruiting
25
Illinois Retina Associates, S.C. - Oak Park (01061)
Oak Park, Illinois, United States, 60304
Actively Recruiting
26
Midwest Eye Institute (01066)
Carmel, Indiana, United States, 46032
Actively Recruiting
27
Advancing Research International. LLC (01090)
Indianapolis, Indiana, United States, 46214
Actively Recruiting
28
Retina Consultants P.C.
Indianapolis, Indiana, United States, 46214
Actively Recruiting
29
Retina Associates New Orleans - Jefferson Parish Location
Metairie, Louisiana, United States, 70001
Actively Recruiting
30
The Retina Group of Washington (01089)
Chevy Chase, Maryland, United States, 29902
Actively Recruiting
31
Cumberland Valley Retina Consultants (CVRC)
Hagerstown, Maryland, United States, 21740
Actively Recruiting
32
Mississippi Retina Associates
Madison, Mississippi, United States, 39110
Actively Recruiting
33
Envision Ocular, LLC (01027)
Bloomfield, New Jersey, United States, 07003
Actively Recruiting
34
Mid Atlantic Retina (01039)
Cherry Hill, New Jersey, United States, 08034
Actively Recruiting
35
NJ Retina (01031)
Edison, New Jersey, United States, 08820
Actively Recruiting
36
NJ Retina (01030)
Toms River, New Jersey, United States, 08755
Actively Recruiting
37
Vision Research Center Eye Associates of New Mexico (01023)
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
38
Long Island Vitreoretinal Consultants (01050)
Great Neck, New York, United States, 11021
Actively Recruiting
39
Long Island Vitreoretinal Consultants - Westbury
Long Island City, New York, United States, 11590
Actively Recruiting
40
Retina Assocaites of Cleveland, Inc (01048)
Cleveland, Ohio, United States, 44122
Actively Recruiting
41
Verum Research, LLC
Eugene, Oregon, United States, 97401
Actively Recruiting
42
EyeHealth Northwest
Portland, Oregon, United States, 97225
Actively Recruiting
43
EyeHealth Northwest (01006)
Portland, Oregon, United States, 97228
Actively Recruiting
44
Cascade Medical Research Institute, LLC (01070)
Springfield, Oregon, United States, 97477
Actively Recruiting
45
Mid Atlantic Retina - Philadelphia (01017)
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
46
Charleston Neuroscience Institute (01037)
Beaufort, South Carolina, United States, 29902
Actively Recruiting
47
Retina Consultants of Carolina, PA (01073)
Greenville, South Carolina, United States, 29605
Actively Recruiting
48
Charleston Neuroscience Institute LLC - Ladson
Ladson, South Carolina, United States, 29456
Actively Recruiting
49
Charleston Neuroscience Institute, LLC - Mount Pleasant (01051)
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
50
Ophthalmology Ltd. (01084)
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
51
Tennessee Retina, PC (01063)
Nashville, Tennessee, United States, 37203
Actively Recruiting
52
Retina Consultants of Texas - Abilene (01035)
Abilene, Texas, United States, 79606
Actively Recruiting
53
Austin Retina Associates
Austin, Texas, United States, 78705
Actively Recruiting
54
Retina Consultants of Texas - Bellaire (01067)
Bellaire, Texas, United States, 77401
Actively Recruiting
55
Texas Retina Associates
Dallas, Texas, United States, 75231
Actively Recruiting
56
Retina Consultants of Texas - Katy
Katy, Texas, United States, 77494
Actively Recruiting
57
Valley Retina Institute- McAllen (01076)
McAllen, Texas, United States, 78503
Actively Recruiting
58
Austin Retina Associates - Round Rock (01032)
Round Rock, Texas, United States, 78681
Actively Recruiting
59
Retina Consultants of Texas - San Antonio Medical Center
San Antonio, Texas, United States, 78240
Actively Recruiting
60
Austin Retina Associate (01046)
San Marcos, Texas, United States, 78666
Actively Recruiting
61
Retina Consultants of Texas (01055)
Schertz, Texas, United States, 78154
Actively Recruiting
62
Retina Center of Texas - Southlake
Southlake, Texas, United States, 76092
Actively Recruiting
63
Retina Consultants of Texas - The Woodlands
The Woodlands, Texas, United States, 73384
Actively Recruiting
64
Tyler Retina Consultants
Tyler, Texas, United States, 75703
Actively Recruiting
65
Retina Associates of Utah (01052)
Salt Lake City, Utah, United States, 84107
Actively Recruiting
66
Salt Lake Retina (01044)
West Jordan, Utah, United States, 84088
Actively Recruiting
67
Piedmont Eye Center (01097)
Lynchburg, Virginia, United States, 24502
Actively Recruiting
68
University of Wisconsin Health - University Station Clinic
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
A
Apellis Clinical Trial Information Line
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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