AVD-104 for Age-Related Macular Degeneration (SIGLEC Trial)

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Aviceda Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

This trial is for people with a specific eye condition called Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD). Participants must have certain levels of vision clarity, as measured by an eye chart. They should not have the wet form of AMD or other eye conditions that might need treatment during the study.

Inclusion Criteria

I have been diagnosed with a type of age-related macular degeneration that does not affect the center of my vision.

My eye condition can be fully seen and imaged without touching the optic nerve area.

Exclusion Criteria

My study eye has specific eye conditions.

I have wet AMD or CNV diagnosed by specific eye scans.

Participant Groups

The study tests multiple doses of AVD-104, given through injections into the eye, to see if it's safe and effective for treating GA in AMD patients. Some participants will receive a sham injection instead to serve as a comparison group.

4Treatment groups

Experimental Treatment

Active Control

Group I: Part 1Experimental Treatment1 Intervention

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.

Group II: Part 2: High dose AVD-104Active Control1 Intervention

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.

Group III: Part 2: AvacincaptadActive Control1 Intervention

100 participants will be randomized to receive monthly injections of avacincaptad (2 mg. intravitreal)

Group IV: Part 2: Low dose AVD-104Active Control1 Intervention

100 participants will be randomized and treated with monthly intravitreal injections of low dose AVD-104 for 24 months.