Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)

Adverum Biotechnologies

Status: Active, not recruiting

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Genetic: ADVM-022

Study type: Observational

Funder types: Industry

Identifiers

NCT05607810

ADVM-022-10

Details and patient eligibility

About

This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.

Full description

This is a multi-center study to evaluate the long-term safety and tolerability of a single intravitreal (IVT) injection of ADVM-022 in a preceding "parent" study, ADVM-022-04 [INFINITY]. Participants will be followed for a total of 5 years post- ADVM-022 administration (inclusive of the parent study). There is no investigational treatment administered in this study.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have participated in the ADVM-022-04 [INFINITY] (parent) study and received ADVM-022
• Must provide signed informed consent
• Must be willing and able to comply with all study procedures

Exclusion criteria

• None

Trial design

22 participants in 1 patient group

No Intervention - Subjects who received ADVM-022 in prior clinical study

Treatment:

Genetic: ADVM-022