Actively Recruiting
Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
Led by ONL Therapeutics · Updated on 2025-12-05
324
Participants Needed
28
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to collect efficacy and safety information of intravitreal injection for 3 experimental arms, including 2 dose levels of ONL1204 and 2 treatment frequencies in patients with GA associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability and legal blindness globally. Associated with aging, cigarette smoking, obesity, diets low in certain nutrients, a lifestyle related to cardiac risk, and a growing list of genetic factors, AMD is becoming an increasingly prevalent public health concern, especially as the global population ages. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease, including models of dry AMD.
CONDITIONS
Official 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 provide informed consent and attend study visits
- Women or intersex individuals must use two forms of effective contraception during the study and for 90 days after last dose, be postmenopausal for at least 12 months, or surgically sterile
- Men or intersex individuals with partners of childbearing potential must use contraception and avoid sperm donation during the study and for 90 days after last dose
- Willingness to continue or not use Age-related Eye Disease Study 2 (AREDS2) or similar nutraceutical therapy consistently during the study
- Study eye must have best corrected visual acuity (BCVA) of 24 letters or more using ETDRS charts at screening
- Intraocular pressure of 22 mmHg or lower in the study eye at screening
- Non-foveal GA associated with AMD without exudative macular neovascularization in the study eye
- GA lesion size in the study eye between 0.85 and 8.05 disc areas, with at least one focal lesion 0.425 disc areas or larger if multifocal
- GA lesion border within 1725 microns of the foveal center but not subfoveal
- GA lesion fully visible on macula-centered fundus autofluorescence imaging and not connected to peripapillary atrophy
- Pattern of hyper-autofluorescence in the junctional zone of GA in the study eye
- Fellow eye with BCVA of 19 letters or more using ETDRS charts 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
- Current or planned use of systemic complement inhibitors during the study
- Any ocular or systemic condition that could affect safety or study assessments
- Use of medications toxic to the lens, retina, or optic nerve within 90 days prior to screening or anticipated during the study
- Previous treatment with pentosan polysulfate (Elmiron�ae)
- Known allergy to fluorescein, povidone iodine, study drug ingredients, or avacincaptad pegol
- Pregnancy, planning to become pregnant, 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 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
- Previous yttrium aluminum garnet capsulotomy within 1 month prior to screening
- Planned cataract surgery in the study eye during the study
- Aphakia without posterior capsule in the study eye
- Evidence or history of wet AMD or retinal diseases other than AMD in the study eye
- Intraocular surgery in the study eye within 3 months prior to screening
- Previous therapeutic radiation in the study eye region
- Planned intravitreal injection in the fellow eye during the study with agents other than approved complement inhibitors
- Active intraocular inflammation or history of uveitis or endophthalmitis in either eye
- GA due to causes other than AMD in either eye
- Ophthalmic conditions 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
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
CONTACT
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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