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

Adverum Biotechnologies

Status: Active, not recruiting

Conditions: Wet Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration

Treatments: Biological: ADVM-022

Study type: Observational

Funder types: Industry

Identifiers

NCT04645212

ADVM-022-07

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who received a single dose of ADVM-022 at any dose in the OPTIC study
• Willing and able to provide informed consent

Exclusion criteria

• None

Trial design

23 participants in 1 patient group

1

Description:

Participants with wet AMD who received any dose of ADVM-022 in a prior clinical study.

Treatment:

Biological: ADVM-022