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

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aviceda Therapeutics, Inc.

Criteria

Inclusion Criteria:

Part 1:

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)

2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA)

3. GA may be center involved.

Part 2:

1. BCVA in the study eye using ETDRS Chart VAS of 24 letters or better (equivalent to Snellen VA of 20/320 or better)

2. Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA

3. GA can be multifocal, and cumulative GA lesion must reside completely within the fundus autofluorescence (FAF) imaging field (field 2, 30-degree image centered on the fovea), as confirmed by the central Reading Center

4. Total GA area must be ≥ 2.5 and ≤ 15.5 mm2 (1 and 7 disk areas [DA], respectively)

5. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified in 4 above.

6. Presence of any pattern of hyper-autofluorescence in the junctional zone of GA.

7. 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.

Exclusion Criteria:

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:

1. 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.

2. Any active ocular disease or condition that in the opinion of the Investigator could confound visual function or the assessment of the macula or be a contraindication to intravitreal (IVT) injection, e.g., macular hole, epiretinal membrane, macular atrophy or maculopathies due to any disease other than AMD (such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy), uveitis, uncontrolled glaucoma, or ocular infection (diabetes mellitus without retinopathy is not a criterion for exclusion)

3. Any intraocular surgery (except for intraocular lens replacement surgery more than 3 months prior to consent)

4. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination.

5. 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.