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

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ClinicalTrials.gov Identifier: NCT04645212
Recruitment Status : Active, not recruiting
First Posted : November 27, 2020
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Adverum Biotechnologies, Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Wet Age-related Macular Degeneration Neovascular Age-related Macular Degeneration Biological: ADVM-022

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 Design
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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept

Groups and Cohorts
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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 Name: AAV.7m8-aflibercept


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Percentage of subjects requiring supplemental aflibercept over time [ Time Frame: 156 weeks ]
    Percentage of subjects requiring supplemental aflibercept over time

  4. Mean number of supplemental aflibercept injections over time [ Time Frame: 156 weeks ]
    Mean number of supplemental aflibercept injections over time

  5. 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

  6. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645212


Locations
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United States, California
Adverum Clinical Site
Bakersfield, California, United States, 93309
Adverum Clinical Site
Beverly Hills, California, United States, 90211
United States, Colorado
Adverum Clinical Site
Lakewood, Colorado, United States, 80228
United States, Florida
Adverum Clinical Site
Deerfield Beach, Florida, United States, 33064
United States, Nevada
Adverum Clinical Site
Reno, Nevada, United States, 89502
United States, Pennsylvania
Adverum Clinical Site
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Adverum Clinical Site
Nashville, Tennessee, United States, 37203
United States, Texas
Adverum Clinical Site
Bellaire, Texas, United States, 77401
Adverum Clinical Site
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Adverum Biotechnologies, Inc.
Investigators
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Study Director: OPTIC Medical Monitor Adverum Biotechnologies, Inc.
More Information
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Responsible Party: Adverum Biotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT04645212    
Other Study ID Numbers: ADVM-022-07
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adverum Biotechnologies, Inc.:
Choroidal Neovascularization
ADVM-022
OPTIC Study
CNV
ADVM-022-01
ADVM-022-07
AAV.7m8
Anti-VEGF therapy
Blindness
Gene therapy
Aflibercept (Eylea)
Age-Related Macular Degeneration
Wet Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases
AAV Vector
Adverum
wAMD
AMD
wet AMD
nAMD
OPTIC Extension
OPTIC-EXT
Long-term Follow Up
Long-term Extension
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents