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

Study Overview
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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.

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.

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

Conditions
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Diabetic Macular Edema, Diabetic Retinopathy

Intervention / Treatment
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* Genetic: ADVM-022


Participation Criteria
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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 Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention - Subjects who received ADVM-022 in prior clinical study<br> | Genetic: ADVM-022<br>* Long term follow-up of subjects who previously received ADVM-022<br>* Other names: AAV.7m8-aflibercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ocular and non-ocular adverse events (AEs) |  | 168 Weeks | 
| Severity of ocular and non-ocular AEs |  | 168 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to worsening of DME disease activity |  | 168 Weeks | 
| Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT |  | 168 Weeks | 
| Change from Baseline in BCVA over time |  | 168 Weeks | 
| Incidence of 2-step and 3-step improvement in DRSS score over time |  | 168 Weeks | 
| Incidence of 2-step and 3-step worsening in DRSS score over time |  | 168 Weeks | 
| Frequency of supplemental aflibercept (2mg IVT) injections over time |  | 168 Weeks | 
| Occurrence of vision-threatening complications over time |  | 168 Weeks | 
| Incidence of CST < 300 μm over time |  | 168 Weeks | 
| Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation |  | 168 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAV Vector, ADVM-022-10, INFINITY, ADVM-022, ADVM-022-04, AAV.7m8, Anti-VEGF therapy, Blindness, Gene therapy, Aflibercept (Eylea), Retinal Diseases, Eye Diseases, Adverum, DME, DR, INFINITY-EXT, INFINITY-Extension, Diabetic eye disease, Long-term Extension, Long-term Follow-up, AAV vector