Neovascular Age-related Macular Degeneration Clinical Trial
Official title:
A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension
ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).
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. ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD). To evaluate potential long-term outcomes of ADVM-022, the OPTIC-EXT will follow subjects previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 [OPTIC] (NCT03748784)). Subjects will roll over from the OPTIC parent study and will be followed for 3 additional years, following completion of the preceding 2-year assessment period in the OPTIC parent study. There is no investigational treatment administered in this study. ;
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