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

Phase 2

Waitlist Available

Research Sponsored by Aviceda Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of AMD that is non-center involving (i.e., non-sub-foveal) GA

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.

Must not have

Presence of the following ocular conditions - in the Study Eye:

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the safety, effectiveness, and how a medication affects the body when used to treat age-related macular degeneration.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, inflammation inside the eye, changes in vision, or possible allergic reactions. The full range of side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My study eye has specific eye conditions.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of Dose Limiting Toxicity in Part 1

The Rate of Change in Area of Geographic Atrophy at Month 12 in Participants in Part 2

Secondary study objectives

Prevention of Vision Loss from Baseline in Participants in Part 2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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. Participants from Part 1 will be offered the opportunity to receive monthly injections of high dose AVD-104 once the 6-month timepoint has been reached for 50% of the participants in Part 2. These participants will be followed for safety only.

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.

0 / 4Eligibility criteria met