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ADVM-022 Intravitreal Gene Therapy for DME

NCT04418427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-10

Study results available
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Summary

A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\]

Conditions

Interventions

BIOLOGICAL

6E11 vg/eye of ADVM-022

ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept

BIOLOGICAL

2E11 vg/eye of ADVM-022

ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept

BIOLOGICAL

Aflibercept

Commercially available Active Comparator

Sponsors & Collaborators

  • Adverum Biotechnologies, Inc.

    lead INDUSTRY

Principal Investigators

  • INFINITY Medical Monitor, MD · Adverum Biotechnologies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2022-11-22
Completion
2023-06-14
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418427 on ClinicalTrials.gov