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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-10

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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

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Diabetic Macular Edema Diabetic Retinopathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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

ADVM-022

Intervention Type GENETIC

Long term follow-up of subjects who previously received ADVM-022

Interventions

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ADVM-022

Long term follow-up of subjects who previously received ADVM-022

Intervention Type GENETIC

Other Intervention Names

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AAV.7m8-aflibercept

Eligibility Criteria

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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