NCT05607810

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
2 countries

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

October 21, 2022

Last Update Submit

April 17, 2025

Conditions

Diabetic Macular EdemaDiabetic Retinopathy

Keywords

ADVM-022ADVM-022-04ADVM-022-10AAV.7m8Anti-VEGF therapyBlindnessINFINITYGene therapyAflibercept (Eylea)Retinal DiseasesEye DiseasesAAV VectorAdverumDMEDRINFINITY-EXTINFINITY-ExtensionDiabetic eye diseaseLong-term Extension, Long-term Follow-up, AAV vector

Outcome Measures

Primary Outcomes (2)

  • Incidence of ocular and non-ocular adverse events (AEs)

    168 Weeks

  • Severity of ocular and non-ocular AEs

    168 Weeks

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

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

Genetic: ADVM-022

Interventions

ADVM-022GENETIC

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

Also known as: AAV.7m8-aflibercept
No Intervention - Subjects who received ADVM-022 in prior clinical study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Adverum Clinical Site

Beverly Hills, California, 90211, United States

Location

Adverum Clinical Site

Reno, Nevada, 89502, United States

Location

Adverum Clinical Site

Philadelphia, Pennsylvania, 19107, United States

Location

Adverum Clinical Site

Austin, Texas, 78705, United States

Location

Adverum Clinical Site

Bellaire, Texas, 77030, United States

Location

Adverum Clinical Site

The Woodlands, Texas, 77384, United States

Location

Adverum Clinical Site

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic RetinopathyBlindnessRetinal DiseasesEye Diseases

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adam Turpcu, Ph.D.

    Adverum Biotechnologies

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

November 7, 2022

Study Start

August 10, 2022

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations

US(6)PR(1)