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

September 14, 2026 updated by: Aviceda Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Associated Retina Consultants
      • Phoenix, Arizona, United States, 85021
        • Arizona Retina and Vitreous Consultants
      • Scottsdale, Arizona, United States, 85260
        • Associated Retina Consultants
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates Medical Group
      • Glendale, California, United States, 91203
        • Macula & Retina Institute
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • Riverside, California, United States, 92505
        • Kaiser Permanente
      • Sacramento, California, United States, 95841
        • Retinal Consultants Medical Group
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group, Inc.
      • San Francisco, California, United States, 94101
        • West Coast Retina
      • Santa Barbara, California, United States, 93103
        • RCA: California Retina Consultants
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England, PC
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
      • Tallahassee, Florida, United States, 32308
        • Southern Vitreoretinal Associates
      • Winter Haven, Florida, United States, 33880
        • Center for Retina & Macular Disease
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
    • Illinois
      • Chicago, Illinois, United States, 60439
        • University Retina and Macula Associates
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Springfield, Massachusetts, United States, 01107
        • New England Retina Consultants
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Retina Specialists of Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Retina Consultants of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Mississippi Retina Associates
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Retina Center of New Jersey
      • Edison, New Jersey, United States, 08820
        • NJ Retina
    • New York
      • Syracuse, New York, United States, 13088
        • Retina-Vitreous Surgeons of Central NY
      • Westbury, New York, United States, 11590
        • Long Island Vitreoretinal Consultants
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • North Carolina Retina Associates
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Associates of Cleveland, Inc
      • Cleveland, Ohio, United States, 44130
        • Retina Associates of Cleveland
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Mid-Atlantic Retina
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Retina Consultants of Charleston
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas Abilene TX
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
      • Fort Worth, Texas, United States, 76104
        • Texas Retina Associates
      • McAllen, Texas, United States, 78504
        • Valley Retina Institute
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas
      • San Antonio, Texas, United States, 78503
        • Retina Consultants of Texas
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Part 2: High dose 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.
Drug: AVD-104
Intravitreal injection
Active Comparator: Part 2: Low dose AVD-104
100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.
Drug: AVD-104
Intravitreal injection
Active Comparator: Part 2: Avacincaptad
100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)
Drug: Avacincaptad
Intravitreal injection of 2 mg avacincaptad
Experimental: Part 1
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.
Drug: AVD-104
Intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Dose Limiting Toxicity in Part 1
Time Frame: 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
3 months
The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2
Time Frame: 12 months
The rate of change from baseline in area of GA as measured by fundus autofluorescence at month 12.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of Vision Loss from Baseline in Participants in Part 2
Time Frame: 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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aviceda Therapeutics, Inc.

Investigators

  • Study Director: David Callanan, MD, Aviceda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

February 18, 2026

Study Completion (Actual)

February 18, 2026

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVD-104-C01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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