Clinical trial NCT05839041: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Geographic Atrophy of the Macula
Macular Degeneration
Keywords: Age-related Macular Degeneration
Geographic Atrophy
Dry AMD
Lead sponsor: Aviceda Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 300
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 - Open Label, Multi-Center, Dose Escalation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of Dose Limiting Toxicity in Part 1
timeFrame: 3 months
measure: The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2
timeFrame: 12 months
Secondary outcomes:
measure: Prevention of Vision Loss from Baseline in Participants in Part 2
timeFrame: 12 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Scottsdale
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Glendale
country: United States
facility: Macula & Retina Institute
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Riverside
country: United States
facility: Kaiser Permanente
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: San Francisco
country: United States
facility: West Coast Retina
state: California
city: Santa Barbara
country: United States
facility: RCA: California Retina Consultants
state: California
city: Waterford
country: United States
facility: Retina Group of New England, PC
state: Connecticut
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina & Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Chicago
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Grand Rapids
country: United States
facility: Retina Specialists of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Minneapolis
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Retina Center of New Jersey
state: New Jersey
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Syracuse
country: United States
facility: Retina-Vitreous Surgeons of Central NY
state: New York
city: Westbury
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland, Inc
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Bethlehem
country: United States
facility: Mid-Atlantic Retina
state: Pennsylvania
city: Erie
country: United States
facility: Erie Retina Research, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Retina Consultants of Charleston
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas Abilene TX
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
Study officials:
affiliation: Aviceda Therapeutics
name: David Callanan, MD
role: STUDY_DIRECTOR
References: