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

Macular Degeneration Clinical Trial

— SIGLEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839041
• Other study ID #: AVD-104-C01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2, 2023
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Aviceda Therapeutics, Inc.
• Contact: David Callanan, MD
• Phone: 617-225-4343
• Email: clinical[@]avicedarx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• AVD-104
Intravitreal injection
• Avacincaptad
Intravitreal injection of 2 mg avacincaptad

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas Abilene TX	Abilene	Texas
United States	West Texas Retina Consultants (Integrated Clinical Research, LLC)	Abilene	Texas
United States	Texas Retina Associates	Arlington	Texas
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	Retina Associates of Cleveland, Inc	Beachwood	Ohio
United States	Mid-Atlantic Retina	Bethlehem	Pennsylvania
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Retina Center of New Jersey	Bloomfield	New Jersey
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Retina Consultants of Charleston	Charleston	South Carolina
United States	University Retina and Macula Associates	Chicago	Illinois
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Texas Retina Associates	Dallas	Texas
United States	Rand Eye Institute	Deerfield Beach	Florida
United States	NJ Retina	Edison	New Jersey
United States	Retina Vitreous Center	Edmond	Oklahoma
United States	Erie Retina Research, LLC	Erie	Pennsylvania
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Texas Retina Associates	Fort Worth	Texas
United States	Associated Retina Consultants	Gilbert	Arizona
United States	Macula & Retina Institute	Glendale	California
United States	Retina Specialists of Michigan	Grand Rapids	Michigan
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Mississippi Retina Associates	Jackson	Mississippi
United States	Valley Retina Institute	McAllen	Texas
United States	Retina Consultants of Minnesota	Minneapolis	Minnesota
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina	Nashville	Tennessee
United States	Illinois Retina Associates	Oak Park	Illinois
United States	Florida Retina Institute	Orlando	Florida
United States	Retina Specialty Institute	Pensacola	Florida
United States	Arizona Retina and Vitreous Consultants	Phoenix	Arizona
United States	Sierra Eye Associates	Reno	Nevada
United States	Kaiser Permanente	Riverside	California
United States	Associated Retinal Consultants	Royal Oak	Michigan
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Retinal Consultants Medical Group, Inc.	Sacramento	California
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Rocky Mountain Retina Consultants	Salt Lake City	Utah
United States	Retina Consultants of Texas	San Antonio	Texas
United States	Retina Consultants of Texas	San Antonio	Texas
United States	West Coast Retina	San Francisco	California
United States	RCA: California Retina Consultants	Santa Barbara	California
United States	Associated Retina Consultants	Scottsdale	Arizona
United States	Spokane Eye Clinic	Spokane	Washington
United States	New England Retina Consultants	Springfield	Massachusetts
United States	Retina-Vitreous Surgeons of Central NY	Syracuse	New York
United States	Southern Vitreoretinal Associates	Tallahassee	Florida
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	North Carolina Retina Associates	Wake Forest	North Carolina
United States	Retina Group of New England, PC	Waterford	Connecticut
United States	Palmetto Retina Center	West Columbia	South Carolina
United States	Long Island Vitreoretinal Consultants	Westbury	New York
United States	Center for Retina & Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aviceda Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Visual Acuity Change from Baseline in Participants in Part 2	The change from baseline in best-corrected visual acuity (BCVA) (assessed with ETDRS visual acuity) in Participants at Month 12	12 months