Last updated on March 2019

ADVM-022 Gene Therapy for Wet AMD


Brief description of study

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require lifelong intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and preserving the vision of patients. ADVM-022 is designed to reduce the current treatment burden and the adverse events (AEs) associated with chronic IVT injections.

Detailed Study Description

This open-label, multicenter, dose-escalation study will evaluate 3 dose levels in 18 subjects (6 per dose) with active choroidal neovascularization (CNV) secondary to AMD. Subjects who are under active anti-VEGF treatment and have demonstrated a meaningful response to anti-VEGF therapy will be considered for participation in this study. The primary endpoint for this study is safety and tolerability of ADVM-022. All subjects will continue to be assessed for 104 weeks following treatment with ADVM-022.

Clinical Study Identifier: NCT03748784

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Adverum Clinical Site

Bakersfield, CA United States
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Adverum Clinical Site

Beverly Hills, CA United States
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Adverum Clinical Site

Colorado Springs, CO United States
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Adverum Clinical Site

Golden, CO United States
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Adverum Clinical Site

Philadelphia, PA United States
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Adverum Clinical Site

Nashville, TN United States
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Adverum Clinical Site

Houston, TX United States
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Adverum Clinical Site

The Woodlands, TX United States
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Recruitment Status: Open


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