A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Running, not enrolling · Phase 2

Conditions studied: Geographic Atrophy of the Macula, Macular Degeneration

In brief

Investigate the Safety, Pharmacokinetics, and Treatment effects of Single and Multi-dose of Intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.

Key facts

Study ID

NCT05839041

Run by

Aviceda Therapeutics, Inc.

People needed

300

Starts

2023-05-02

Expected to finish

2026-10-01

Last updated by the study team

2025-11-20

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part 1:
• BCVA in the study eye using ETDRS Chart Visual Acuity Scale (VAS) of 5 to 55 letters (equivalent to Snellen VA of approximately 20/800 - 20/80)
• If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA)
• GA may be center involved.
• Part 2:
• BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better)
• Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA in 50% of participants. Center involvement allowed in 50% of participants.
• 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.

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Part 1 and 2
• Presence of the following ocular conditions - in the Study Eye:
• Exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (SD-OCT) imaging and/or fluorescein angiography as assessed by the Reading Center.
• 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.

Where it is running

• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
• Associated Retina Consultants — Scottsdale, Arizona, United States
• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Macula & Retina Institute — Glendale, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Kaiser Permanente — Riverside, California, United States
• Retinal Consultants Medical Group, Inc. — Sacramento, California, United States
• Retinal Consultants Medical Group — Sacramento, California, United States
• West Coast Retina — San Francisco, California, United States
• RCA: California Retina Consultants — Santa Barbara, California, United States
• Retina Group of New England, PC — Waterford, Connecticut, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• Southern Vitreoretinal Associates — Tallahassee, Florida, United States
• Center for Retina & Macular Disease — Winter Haven, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• University Retina and Macula Associates — Chicago, Illinois, United States
• Illinois Retina Associates — Oak Park, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Associated Retina Consultants — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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