Actively Recruiting
A Phase 2 Study to Evaluate Safety and Efficacy of ONL1204 Compared to Sham and Avacincaptad Pegol in Patients With Geographic Atrophy Associated With Age-Related Macular Degeneration
Led by ONL Therapeutics · Updated on 2025-12-05
324
Participants Needed
28
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of intravitreal injections of ONL1204 in patients with geographic atrophy (GA) linked to age-related macular degeneration (AMD). This phase 2, randomized, double-masked, sham-controlled study aims to collect information on different doses and treatment frequencies of ONL1204, a new type of drug that may protect retinal cells. GA associated with AMD is a major cause of vision loss worldwide, influenced by aging, lifestyle factors, and genetics. Participants will receive one of several treatments: two doses of ONL1204 (100 µg or 200 µg) given every 12 weeks, a 200 µg dose every 24 weeks, sham injections every 12 or 24 weeks, or monthly injections of Avacincaptad Pegol. All treatments are delivered by intravitreal injection into the eye. The study includes six treatment groups to compare these different approaches. During the 48-week treatment period, participants will attend regular visits for injections and evaluations. Researchers will monitor vision, eye pressure, retinal health, and safety through various examinations and imaging. The main measurement is the primary endpoint assessed from enrollment until the end of treatment. Safety will also be closely observed. Participants must be at least 55 years old with specific eye health criteria to take part, and their involvement includes ongoing assessments to understand treatment effects and safety.
CONDITIONS
Brief Title
Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 55 years of age or older at Screening
- Able and willing to give informed consent and attend study visits
- Women or intersex individuals must use two forms of contraception during the study or be postmenopausal for at least 12 months or surgically sterile; negative pregnancy tests required if of childbearing potential
- Men or intersex individuals with partners of childbearing potential must use contraception and avoid sperm donation during and for 90 days after the study
- Willing to continue or not use Age-related Eye Disease Study 2 (AREDS2) or similar nutraceutical therapy consistently during the study
- Best-corrected visual acuity (BCVA) of 24 letters or more in the study eye at Screening
- Intraocular pressure (IOP) of 22 mmHg or lower in the study eye at Screening
- Non-foveal geographic atrophy (GA) associated with AMD without exudative macular neovascularization (eMNV) in the study eye, confirmed by central reading center
- GA lesion size between 0.85 and 8.05 disc areas in the study eye as confirmed by central reading center
- At least one focal lesion of 0.425 disc areas or larger if GA is multifocal
- GA lesion border 1725 microns or less from the foveal center in the study eye
- Entire GA lesion must be fully visualized on macula-centered fundus autofluorescence image and not contiguous with peripapillary atrophy
- Presence of hyper-autofluorescence pattern in the junctional zone of GA
- Best-corrected visual acuity (BCVA) of 19 letters or more in the fellow eye at Screening
You will not qualify if you...
- Participation in another investigational study or use of investigational drugs/devices within 6 months prior to enrollment or during the study without sponsor approval
- Previous ophthalmic gene therapy or planned gene therapy participation during the study
- Use of systemic complement inhibitors during the study
- Any ocular or systemic condition making patient unsuitable for investigational drug treatment or safety/efficacy assessments
- Treatment with ocular or systemic medications toxic to lens, retina, or optic nerve within 90 days prior to Screening or anticipated during the study
- Previous treatment with pentosan polysulfate (Elmiron�)
- Known allergy to fluorescein, povidone iodine, or ingredients of study drugs
- Pregnancy, planning pregnancy, or nursing during the study
- Active ocular or periocular infection in the study eye
- Contraindication to intravitreal injection in the study eye
- Media opacity limiting vision or retinal imaging in the study eye
- Previous intravitreal pharmaceutical treatment in the study eye except FDA-approved complement inhibitors within 12 weeks prior to Screening
- History of incisional retinal or glaucoma surgery in the study eye
- Yttrium aluminum garnet capsulotomy in the study eye within 1 month prior to Screening
- Planned or expected cataract surgery or aphakia without posterior capsule in the study eye
- Evidence or history of wet AMD in the study eye
- Other significant retinal diseases except benign degenerative conditions in the study eye
- Intraocular surgery in the study eye within 3 months prior to Screening
- Previous therapeutic radiation in the region of the study eye
- Planned intravitreal injection in fellow eye with agents other than FDA-approved complement inhibitors during the study
- Active intraocular inflammation or history of uveitis or endophthalmitis in either eye
- GA in either eye due to causes other than AMD
- Ophthalmic condition likely to require surgery during the study in either eye
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 - 48 weeks
Participants receive intravitreal injections of ONL1204, Avacincaptad Pegol, or sham injections according to their assigned group to evaluate safety and efficacy.
Injections every 12 weeks, 24 weeks, or monthly depending on treatment group
Trial Site Locations
Total: 28 locations
1
Associated Retina Consultants
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
Actively Recruiting
3
Doheny Image Reading Center
Pasadena, California, United States, 91103
Actively Recruiting
4
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
Actively Recruiting
5
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, United States, 80909-1183
Actively Recruiting
6
Retina Group of New England
Waterford, Connecticut, United States, 06385
Actively Recruiting
7
Florida Retina Institute
Orlando, Florida, United States, 32806
Actively Recruiting
8
Retina Associates, Ltd.
Elmhurst, Illinois, United States, 60126
Actively Recruiting
9
Retina Partners Midwest, P.C.
Carmel, Indiana, United States, 46032
Actively Recruiting
10
Retina Research Institute at New England Retina Consultants
Springfield, Massachusetts, United States, 01107
Actively Recruiting
11
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
Actively Recruiting
12
The Retina Institute
St Louis, Missouri, United States, 63128
Actively Recruiting
13
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
14
Retina Associates of Western NY
Rochester, New York, United States, 14620
Actively Recruiting
15
Long Island Vitreoretinal Consultants
Westbury, New York, United States, 11590
Actively Recruiting
16
North Carolina Retina Associates, S.C.
Wake Forest, North Carolina, United States, 27587
Actively Recruiting
17
Erie Retina Research, LLC (Clinic)
Erie, Pennsylvania, United States, 16505
Actively Recruiting
18
Charleston Neuroscience Institute
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
19
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
Actively Recruiting
20
Retina Consultants of Texas
Beaumont, Texas, United States, 77707
Actively Recruiting
21
Retina Consultants of Texas
Bellaire, Texas, United States, 77401
Actively Recruiting
22
Retina Consultants of Texas
Katy, Texas, United States, 77494
Actively Recruiting
23
Retina Associates of South Texas, PA
San Antonio, Texas, United States, 78240
Actively Recruiting
24
Retina Consultants of Texas
San Antonio, Texas, United States, 78240
Actively Recruiting
25
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384
Actively Recruiting
26
Pacific Northwest Retina
Bellevue, Washington, United States, 98004
Actively Recruiting
27
Pacific Northwest Retina, PLLC
Silverdale, Washington, United States, 98383
Actively Recruiting
28
Clinique d'ophtalmologie des Laurentides
Boisbriand, Quebec, Canada, J7H0E8
Actively Recruiting
Research Team
S
Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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