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A Long-Term Follow-Up Study of ADVM-022 in Diabetic Macular Edema- INFINITY Extension
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Adverum Clinical Site
Beverly Hills, California, United States
Adverum Clinical Site
Reno, Nevada, United States
Adverum Clinical Site
Philadelphia, Pennsylvania, United States
Adverum Clinical Site
Austin, Texas, United States
Adverum Clinical Site
Bellaire, Texas, United States
Adverum Clinical Site
The Woodlands, Texas, United States
Adverum Clinical Site
Arecibo, Puerto Rico
Start Date
August 10, 2022
Primary Completion Date
April 1, 2026
Completion Date
April 1, 2026
Last Updated
April 22, 2025
22
ESTIMATED participants
ADVM-022
GENETIC
Lead Sponsor
Adverum Biotechnologies, Inc.
NCT07449936
NCT07449923
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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