NCT05607810

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

A Long-Term Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Adverum Biotechnologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Macular Edema
• Diabetic Retinopathy

Interventions

Type	Name	Description
GENETIC	ADVM-022	Long term follow-up of subjects who previously received ADVM-022

Timeline

• Start date: 2022-08-10
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2022-11-07
• Last updated: 2025-04-22

Locations

7 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study