ADVM-022 Intravitreal Gene Therapy for Wet AMD (OPTIC)

August 4, 2023 updated by: Adverum Biotechnologies, Inc.

An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open-label, multicenter, dose-ranging study will evaluate 2 dose levels in up to 30 subjects (15 per dose) with active choroidal neovascularization (CNV) secondary to AMD. Subjects who are under active anti-VEGF treatment and have demonstrated a meaningful response to anti-VEGF therapy will be considered for participation in this study. The primary endpoint for this study is safety and tolerability of ADVM-022. All subjects will continue to be assessed for 104 weeks following treatment with ADVM-022.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

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

  • United States
    • 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
      • 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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 50
  • Diagnosis of neovascular (wet) AMD
  • BCVA ETDRS Snellen equivalent between ≤20/32 and ≥20/320 for each cohort
  • Subjects must be under active anti-VEGF treatment for wAMD and received a minimum of 2 injections within 4 months prior to screening
  • Demonstrated a meaningful response to anti-VEGF therapy
  • Willing and able to provide consent

Exclusion Criteria:

  • History of retinal disease in the study eye other than wet AMD
  • Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement
  • History of retinal detachment (with or without repair) in the study eye
  • History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
  • Uncontrolled glaucoma in the study eye
  • Any prior treatment with photodynamic therapy or retinal laser for the treatment of wet AMD and any previous therapeutic radiation in the region of the study eye
  • Any previous intraocular or periocular surgery on the study eye within 6 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

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
6E11 vg of ADVM-022
Biological: 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
Experimental: Dose 2
2E11 vg of ADVM-022
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Time Frame: 104 weeks
Type, severity, and incidence of ocular and systemic adverse events (AEs)
104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in best corrected visual acuity (BCVA)
Time Frame: 104 weeks
Change in best corrected visual acuity (BCVA)
104 weeks
Change in central subfield thickness (CST) and macular volume measured by SD-OCT
Time Frame: 104 weeks
Change in central subfield thickness (CST) and macular volume measured by SD-OCT
104 weeks
Percentage of subjects requiring anti-VEGF injections over time
Time Frame: 104 weeks
Percentage of subjects requiring anti-VEGF injections over time
104 weeks
Mean number of anti-VEGF injections over time
Time Frame: 104 weeks
Mean number of anti-VEGF injections over time
104 weeks
Percentage of subjects without intraretinal fluid over time
Time Frame: 104 weeks
Percentage of subjects without intraretinal fluid over time
104 weeks
Percentage of subjects without subretinal fluid over time
Time Frame: 104 weeks
Percentage of subjects without subretinal fluid over time
104 weeks

Collaborators and Investigators

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

Sponsor

Adverum Biotechnologies, Inc.

Investigators

  • Study Chair: OPTIC Medical Monitor, 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)

November 14, 2018

Primary Completion (Actual)

June 22, 2022

Study Completion (Actual)

June 22, 2022

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVM-022-01

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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