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

Last updated: December 11, 2024
Sponsor: Aviceda Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Sham injection

AVD-104

Avacincaptad

Clinical Study ID

NCT05839041
AVD-104-C01
  • Ages 55-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 toSnellen 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 andmust be able to be imaged in its entirety and not contiguous with any areas ofperipapillary atrophy.

Exclusion

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 ofretinal pigment epithelium rips or evidence of neovascularization anywhere based onspectral domain optical coherence tomography (SD-OCT) imaging and/or fluoresceinangiography as assessed by the Reading Center.

  2. Any ocular condition other than GA secondary to AMD that may require surgery ormedical intervention during the study period or, in the opinion of the Investigator,could compromise visual function during the study period.

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Sham injection
Phase: 2
Study Start date:
May 02, 2023
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Associated Retina Consultants

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona 85021
    United States

    Site Not Available

  • Associated Retina Consultants

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Macula & Retina Institute

    Glendale, California 91203
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates

    Mountain View, California 94040
    United States

    Site Not Available

  • Kaiser Permanente

    Riverside, California 92505
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Sacramento, California 95841
    United States

    Site Not Available

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California 95825
    United States

    Site Not Available

  • West Coast Retina

    San Francisco, California 94101
    United States

    Site Not Available

  • RCA: California Retina Consultants

    Santa Barbara, California 93103
    United States

    Site Not Available

  • Retina Group of New England, PC

    Waterford, Connecticut 06385
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Retina Group of Florida

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Florida Retina Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Southern Vitreoretinal Associates

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Center for Retina & Macular Disease

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Southeast Retina Center

    Augusta, Georgia 30909
    United States

    Site Not Available

  • University Retina and Macula Associates

    Chicago, Illinois 60439
    United States

    Site Not Available

  • Illinois Retina Associates

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Midwest Eye Institute

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • New England Retina Consultants

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • Retina Specialists of Michigan

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Associated Retinal Consultants

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Retina Consultants of Minnesota

    Minneapolis, Minnesota 55435
    United States

    Site Not Available

  • Mississippi Retina Associates

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Site Not Available

  • Retina Center of New Jersey

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • NJ Retina

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Retina-Vitreous Surgeons of Central NY

    Syracuse, New York 13088
    United States

    Site Not Available

  • Long Island Vitreoretinal Consultants

    Westbury, New York 11590
    United States

    Site Not Available

  • North Carolina Retina Associates

    Wake Forest, North Carolina 27587
    United States

    Site Not Available

  • Retina Associates of Cleveland, Inc

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Retina Associates of Cleveland

    Cleveland, Ohio 44130
    United States

    Site Not Available

  • Retina Vitreous Center

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Mid-Atlantic Retina

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Erie Retina Research, LLC

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Retina Consultants of Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Palmetto Retina Center

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Tennessee Retina

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Retina Research Institute of Texas Abilene TX

    Abilene, Texas 79606
    United States

    Site Not Available

  • West Texas Retina Consultants (Integrated Clinical Research, LLC)

    Abilene, Texas 79606
    United States

    Site Not Available

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Foundation of the Southwest

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Retina Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Valley Retina Institute

    McAllen, Texas 78504
    United States

    Site Not Available

  • Valley Retina Institute, P.A.

    McAllen, Texas 78503
    United States

    Site Not Available

  • Retina Consultants of Texas

    San Antonio, Texas 78503
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Spokane Eye Clinic

    Spokane, Washington 99204
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.