Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated April 22, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-11-04.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-04-17
Trial Details
NCT Number NCT05607810
Lead Sponsor Adverum Biotechnologies, Inc.
Conditions Diabetic Macular Edema, Diabetic Retinopathy
Enrollment 22 participants
Start Date 2022-08-10
Primary Completion 2026-04 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2025-04-22