A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
SIGLEC
A Single and Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Treatment Effect of Intravitreal AVD-104 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
1 other identifier
interventional
300
1 country
56
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2023
Typical duration for phase_2
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2023
CompletedStudy Start
First participant enrolled
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedNovember 20, 2025
November 1, 2024
2.9 years
April 10, 2023
November 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence of Dose Limiting Toxicity in Part 1
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
3 months
The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2
The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.
12 months
Secondary Outcomes (1)
Prevention of Vision Loss from Baseline in Participants in Part 2
12 months
Study Arms (4)
Part 1
EXPERIMENTALParticipants 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
ACTIVE COMPARATOR100 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
ACTIVE COMPARATOR100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.
Part 2: Avacincaptad
ACTIVE COMPARATOR100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Associated Retina Consultants
Gilbert, Arizona, 85297, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85021, United States
Associated Retina Consultants
Scottsdale, Arizona, 85260, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Macula & Retina Institute
Glendale, California, 91203, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Kaiser Permanente
Riverside, California, 92505, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825, United States
Retinal Consultants Medical Group
Sacramento, California, 95841, United States
West Coast Retina
San Francisco, California, 94101, United States
RCA: California Retina Consultants
Santa Barbara, California, 93103, United States
Retina Group of New England, PC
Waterford, Connecticut, 06385, United States
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Florida Retina Institute
Orlando, Florida, 32806, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Associates
Tallahassee, Florida, 32308, United States
Center for Retina & Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
University Retina and Macula Associates
Chicago, Illinois, 60439, United States
Illinois Retina Associates
Oak Park, Illinois, 60304, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
New England Retina Consultants
Springfield, Massachusetts, 01107, United States
Retina Specialists of Michigan
Grand Rapids, Michigan, 49546, United States
Associated Retinal Consultants
Royal Oak, Michigan, 48073, United States
Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435, United States
Mississippi Retina Associates
Jackson, Mississippi, 39202, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina Center of New Jersey
Bloomfield, New Jersey, 07003, United States
NJ Retina
Edison, New Jersey, 08820, United States
Retina-Vitreous Surgeons of Central NY
Syracuse, New York, 13088, United States
Long Island Vitreoretinal Consultants
Westbury, New York, 11590, United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587, United States
Retina Associates of Cleveland, Inc
Beachwood, Ohio, 44122, United States
Retina Associates of Cleveland
Cleveland, Ohio, 44130, United States
Retina Vitreous Center
Edmond, Oklahoma, 73013, United States
Mid-Atlantic Retina
Bethlehem, Pennsylvania, 18017, United States
Erie Retina Research, LLC
Erie, Pennsylvania, 16507, United States
Retina Consultants of Charleston
Charleston, South Carolina, 29414, United States
Palmetto Retina Center
West Columbia, South Carolina, 29169, United States
Tennessee Retina
Nashville, Tennessee, 37203, United States
Retina Research Institute of Texas Abilene TX
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Texas Retina Associates
Fort Worth, Texas, 76104, United States
Valley Retina Institute
McAllen, Texas, 78504, United States
Retina Consultants of Texas
San Antonio, Texas, 78240, United States
Retina Consultants of Texas
San Antonio, Texas, 78503, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, United States
Spokane Eye Clinic
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Callanan, MD
Aviceda Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Part 2 - Double Masked, Randomized, Multi-Center
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2023
First Posted
May 3, 2023
Study Start
May 2, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
November 20, 2025
Record last verified: 2024-11