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

• Conditions: Diabetic Macular Edema; Diabetic Retinopathy
• Interventions: Genetic: ADVM-022

• Registration Number: NCT05607810
• Lead Sponsor: Adverum Biotechnologies, Inc.

Brief 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.

Study Timeline

• Study Start: 2022-08-10
• Status Verified: 2022-10
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Study First Posted: 2022-11-07
• Last Update Posted: 2022-11-07
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 22

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of ocular and non-ocular adverse events (AEs)	168 Weeks
Severity of ocular and non-ocular AEs	168 Weeks

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Adverum Clinical Site; 🇵🇷 Arecibo, Puerto Rico