Gene Therapy (ADVM-022) for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Adverum Biotechnologies, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Eligibility Criteria

This trial is for people over 50 with wet age-related macular degeneration (nAMD) who've had at least 2-3 anti-VEGF injections in the past 4-6 months. They must have shown improvement from these treatments and have a certain level of vision acuity. Those with uncontrolled diseases, recent eye infections or surgeries, or other retinal issues can't participate.

Inclusion Criteria

I am 50 years old or older.

Willing and able to provide written, signed informed consent for this study

I am currently receiving anti-VEGF injections for wet AMD and have had at least 2 injections in the last 4 months.

+3 more

Exclusion Criteria

I have had a retinal detachment or tear in the past.

I haven't had gene therapy or been part of eye studies recently.

I have had surgery on the back part of my eye.

+8 more

Participant Groups

ADVM-022, a gene therapy product designed to reduce treatment frequency for nAMD by providing sustained release of aflibercept after one injection. The study aims to see if this single treatment can maintain or improve patients' vision compared to regular anti-VEGF injections.

2Treatment groups

Experimental Treatment

Group I: Dose 2Experimental Treatment1 Intervention

A single intravitreal injection of ADVM-022 6E10 vg/eye

Group II: Dose 1Experimental Treatment1 Intervention

A single intravitreal injection of ADVM-022 2E11 vg/eye