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

Phase 2

Active, not recruiting

• Conditions: Geographic Atrophy of the Macula; Macular Degeneration
• Interventions: Drug: AVD-104; Drug: Avacincaptad

• Registration Number: NCT05839041
• Lead Sponsor: Aviceda Therapeutics, Inc.

Brief 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.

Detailed Description

Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (GA) secondary to macular degeneration. They will receive a single intravitreal injection of study drug (AVD-104) and will be followed for 3 months for safety observation. They will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations.

Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with geographic atrophy secondary to macular degeneration. Participants will be randomized to high dose AVD-104, low dose AVD-104, or active comparator (avacincaptad). The primary endpoint will be the difference in the rate of growth of the GA area as measured by fundus autofluorescence.

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-20
• Study Start: 2023-05-02
• Study First Posted: 2023-05-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 in 50% of participants. Center involvement allowed in 50% of participants.
3. 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2: High dose AVD-104	AVD-104	100 participants will be randomized and treated with bimonthly intravitreal injections of high-dose AVD-104 for the first 12 months. They will continue bimonthly injections for months 13-24.
Part 2: Low dose AVD-104	AVD-104	100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.
Part 1	AVD-104	Participants will receive a single intravitreal injection of AVD-104 at one of 4 escalating doses. All participants will be followed up for safety until Month 3.
Part 2: Avacincaptad	Avacincaptad	100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)

Primary Outcome Measures

Name	Time	Method
Occurrence of Dose Limiting Toxicity in Part 1	3 months	The number of participants experiencing a dose limiting toxicity corresponding to a category of 3 or greater on the National Cancer Institute Common Terminology Criteria for Adverse Events
The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2	12 months	The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.

Secondary Outcome Measures

Name	Time	Method
Prevention of Vision Loss from Baseline in Participants in Part 2	12 months	Proportion of participants with 15 or greater letter loss in best corrected visual acuity (BCVA) (assessed with the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual acuity).

Trial Locations

Locations (51)

Associated Retina Consultants; 🇺🇸 Scottsdale, Arizona, United States

Arizona Retina and Vitreous Consultants; 🇺🇸 Phoenix, 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

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