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

April 17, 2025 updated by: Adverum Biotechnologies, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Adverum Clinical Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Adverum Clinical Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Adverum Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Adverum Clinical Site
    • Texas
      • Austin, Texas, United States, 78705
        • Adverum Clinical Site
      • Bellaire, Texas, United States, 77030
        • Adverum Clinical Site
      • The Woodlands, Texas, United States, 77384
        • Adverum Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who received ADVM-022 at any dose in the INFINITY study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Intervention - Subjects who received ADVM-022 in prior clinical study
Genetic: ADVM-022
Long term follow-up of subjects who previously received ADVM-022
Other Names:
  • AAV.7m8-aflibercept

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adverum Biotechnologies, Inc.

Investigators

  • Study Director: Adam Turpcu, Ph.D., Adverum Biotechnologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVM-022-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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