A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
- Conditions
- Geographic Atrophy of the MaculaMacular Degeneration
- Interventions
- Drug: AVD-104Drug: 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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: 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 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
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
🇺🇸Saint 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
New England Retina Consultants
🇺🇸Springfield, Massachusetts, United States
Retina Specialists of Michigan
🇺🇸Grand Rapids, Michigan, United States
Associated Retinal Consultants
🇺🇸Royal Oak, Michigan, United States
Retina Consultants of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mississippi Retina Associates
🇺🇸Jackson, Mississippi, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Retina Center of New Jersey
🇺🇸Bloomfield, New Jersey, United States
NJ Retina
🇺🇸Edison, New Jersey, United States
Retina-Vitreous Surgeons of Central NY
🇺🇸Syracuse, New York, United States
Long Island Vitreoretinal Consultants
🇺🇸Westbury, New York, United States
North Carolina Retina Associates
🇺🇸Wake Forest, North Carolina, United States
Retina Associates of Cleveland, Inc
🇺🇸Beachwood, Ohio, United States
Retina Associates of Cleveland
🇺🇸Cleveland, Ohio, United States
Retina Vitreous Center
🇺🇸Edmond, Oklahoma, United States
Mid-Atlantic Retina
🇺🇸Bethlehem, Pennsylvania, United States
Erie Retina Research, LLC
🇺🇸Erie, Pennsylvania, United States
Retina Consultants of Charleston
🇺🇸Charleston, South Carolina, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Tennessee Retina
🇺🇸Nashville, Tennessee, United States
Retina Research Institute of Texas Abilene TX
🇺🇸Abilene, Texas, United States
Texas Retina Associates
🇺🇸Fort Worth, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
Spokane Eye Clinic
🇺🇸Spokane, Washington, United States
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