NCT04645212

Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]

A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Adverum Biotechnologies, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in participants with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

Detailed description

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 participants with neovascular or exudative (wet), age-related macular degeneration (nAMD) previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 \[OPTIC\] - NCT03748784). There is no investigational treatment administered in this study. In Part 1 of the OPTIC-EXT study participants will roll over from the OPTIC parent study and will be followed for 3 additional years (following 2-years of assessment period in the OPTIC parent study). In Part 2 of the OPTIC-EXT study consenting participants will have 5 annual in-clinic assessments for an additional 5 years of long-term follow-up following the completion of OPTIC-EXT (Part 1). As such participants who complete the parent study as well as Part 1 and Part 2 of the OPTIC-EXT study will have had 10 years of total long-term follow-up.

Conditions

• Wet Age-related Macular Degeneration
• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	ADVM-022	Long term follow-up of subjects that received ADVM-022

Timeline

• Start date: 2020-12-14
• Primary completion: 2030-06-26
• Completion: 2030-06-26
• First posted: 2020-11-27
• Last updated: 2026-02-10

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study