ADVM-022 Intravitreal Gene Therapy for DME (INFINITY)

August 6, 2023 updated by: Adverum Biotechnologies, Inc.

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

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

*sponsor unmasked for enhanced safety monitoring as of May 2021

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of serious retinal vascular diseases including Diabetic Macular Edema (DME). DME affects up to 10% of people with diabetes is caused by fluid accumulation in the macula and is the most frequent cause of sight loss in people with diabetic retinopathy. Available therapies for treating DME include laser and anti-vascular endothelial growth factor (anti-VEGF) drugs. Anti-VEGFs require frequent and long-term intravitreal (IVT) injections to achieve and maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat DME by providing durable expression of an anti-VEGF protein (aflibercept) to limit abnormal blood vessel leakage. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment, progression of disease and subsequent vision loss in patients with DME.

In INFINITY, approximately 33 eligible subjects will be randomly assigned to receive one of the two doses of ADVM-022, or, assigned to the control arm to receive a sham ocular injection with a preceding aflibercept injection. Subjects who are assigned to receive ADVM-022 will be further randomized to receive a preceding aflibercept or sham ocular injection. All subjects will be assessed regularly and will receive additional aflibercept injections should DME disease activity progress.

The primary objective is to assess the durability of a single intravitreal (IVT) injection of ADVM-022. All subjects will be followed for 96 weeks after randomization.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

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
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Adverum Clinical Site
    • California
      • Bakersfield, California, United States, 93309
        • Adverum Clinical Site
      • Beverly Hills, California, United States, 90211
        • Adverum Clinical Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Adverum Clinical Site
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Adverum Clinical Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Adverum Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Adverum Clinical Site
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Adverum Clinical Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Adverum Clinical Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Adverum Clinical Site
      • Austin, Texas, United States, 78705
        • Adverum Clinical Site
      • Houston, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18
  • Type 1 or Type 2 diabetes mellitus
  • Willing and able to provide informed consent
  • Vision impairment due to center involving diabetic macular edema

Exclusion Criteria:

  • Uncontrolled diabetes defined as HbA1C >10%, or history of diabetic ketoacidosis within 3 months prior to randomization; or subjects who, within the last 3 months, initiated intensive insulin treatment (a pump or multiple daily injection) or plan to do so in the next 3 months.
  • Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
  • Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
  • Known severe renal impairment
  • High risk Proliferative Diabetic Retinopathy
  • History of retinal disease in the study eye other than diabetic retinopathy
  • History of retinal detachment (with or without repair) in the study eye
  • History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
  • Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
  • Current or planned pregnancy or breastfeeding

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT
Biological: 6E11 vg/eye of ADVM-022
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
Other Names:
  • AAV.7m8-aflibercept
Biological: Aflibercept
Commercially available Active Comparator
Other Names:
  • Eylea
Experimental: 2
2E11 vg/eye ADVM022 +/- aflibercept 2mg IVT
Biological: Aflibercept
Commercially available Active Comparator
Other Names:
  • Eylea
Biological: 2E11 vg/eye of ADVM-022
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
Other Names:
  • AAV.7m8-aflibercept
Active Comparator: 3
Aflibercept 2mg IVT
Biological: Aflibercept
Commercially available Active Comparator
Other Names:
  • Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to worsening of DME disease activity in the study eye.
Time Frame: 96 weeks
Time to worsening of DME disease activity in the study eye.
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of ocular and non-ocular adverse events (AEs)
Time Frame: 96 weeks
Incidence and severity of ocular and non-ocular adverse events (AEs)
96 weeks
Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT
Time Frame: 96 weeks
Change from Baseline in central subfield thickness (CST) and macular volume over time measured by SD-OCT
96 weeks
Change from Baseline in BCVA over time
Time Frame: 96 weeks
Change from Baseline in BCVA over time
96 weeks
Frequency of rescue aflibercept (2 mg IVT) in the study eye over time during the study
Time Frame: 96 weeks
Frequency of rescue aflibercept (2 mg IVT) in the study eye over time during the study
96 weeks
Incidence of improvement in DRSS score over time
Time Frame: 96 weeks
Incidence of improvement in DRSS score over time
96 weeks
Incidence of worsening in DRSS score over time
Time Frame: 96 weeks
Incidence of worsening in DRSS score over time
96 weeks
Occurrence of vision threatening complication over time
Time Frame: 96 weeks
Occurrence of vision threatening complication over time
96 weeks
Incidence of CST <300 μm over time through Week 48
Time Frame: 96 weeks
Incidence of CST <300 μm over time through Week 48
96 weeks
Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation
Time Frame: 96 weeks
Incidence of clinically significant findings via physical examinations, ocular examinations, imaging, and laboratory evaluation
96 weeks

Collaborators and Investigators

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

Sponsor

Adverum Biotechnologies, Inc.

Investigators

  • Study Chair: INFINITY Medical Monitor, MD, Adverum Biotechnologies, Inc.

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)

May 28, 2020

Primary Completion (Actual)

November 22, 2022

Study Completion (Actual)

November 22, 2022

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVM-022-04

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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