drugset / Trial / NCT03748784

ADVM-022 Intravitreal Gene Therapy for Wet AMD

NCT03748784

Phase 1 Completed 30 enrolled Adverum Biotechnologies, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

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 life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT 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 maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.

Timeline

Start
2018-11-14
Primary completion
2022-06-22
Completion
2022-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject ADVM-022 Gene therapy (AAV / viral vector) 2e+11 vg Intravitreal
Subject ADVM-022 Gene therapy (AAV / viral vector) 6e+11 vg Intravitreal