Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]

February 13, 2023 updated by: Adverum Biotechnologies, Inc.

A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension

ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

To evaluate potential long-term outcomes of ADVM-022, the OPTIC-EXT will follow subjects previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 [OPTIC] (NCT03748784)). Subjects will roll over from the OPTIC parent study and will be followed for 3 additional years, following completion of the preceding 2-year assessment period in the OPTIC parent study. There is no investigational treatment administered in this study.

Study Type

Observational

Enrollment (Actual)

23

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
      • Lakewood, Colorado, United States, 80228
        • 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
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Adverum Clinical Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • 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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Subjects who received ADVM-022 at any dose in the OPTIC study
  • Up to 30 subjects from all cohorts of OPTIC

Description

Inclusion Criteria:

  • Subjects who received a single dose of ADVM-022 at any dose in the OPTIC study
  • Willing and able to provide informed consent

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Subjects with wet AMD who received any dose of ADVM-022 in a prior clinical study.
Biological: ADVM-022
Long term follow-up of subjects that received ADVM-022
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: 156 weeks
Type, severity and incidence of ocular and systemic adverse events
156 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in best corrected visual acuity (BCVA) from baseline, over time
Time Frame: 156 weeks
Change in best corrected visual acuity (BCVA) from baseline, over time
156 weeks
Mean change in central subfield thickness (CST) and macular volume from baseline, over time
Time Frame: 156 weeks
Mean change in central subfield thickness (CST) and macular volume from baseline, over time
156 weeks
Percentage of subjects requiring supplemental aflibercept over time
Time Frame: 156 weeks
Percentage of subjects requiring supplemental aflibercept over time
156 weeks
Mean number of supplemental aflibercept injections over time
Time Frame: 156 weeks
Mean number of supplemental aflibercept injections over time
156 weeks
Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
Time Frame: 156 weeks
Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time
156 weeks
Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time
Time Frame: 156 weeks
Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time
156 weeks

Collaborators and Investigators

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

Sponsor

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)

December 14, 2020

Primary Completion (ANTICIPATED)

June 1, 2025

Study Completion (ANTICIPATED)

June 1, 2025

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (ACTUAL)

November 27, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVM-022-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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