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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748784
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
Adverum Biotechnologies, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wet Age-related Macular Degeneration Neovascular Age-related Macular Degeneration Biological: ADVM-022 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open-label, dose-ranging clinical study to evaluate the safety and tolerability of ADVM-022 in subjects with wet AMD.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration
Actual Study Start Date : November 14, 2018
Actual Primary Completion Date : June 22, 2022
Actual Study Completion Date : June 22, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 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: 104 weeks ]
    Type, severity, and incidence of ocular and systemic adverse events (AEs)


Secondary Outcome Measures :
  1. Change in best corrected visual acuity (BCVA) [ Time Frame: 104 weeks ]
    Change in best corrected visual acuity (BCVA)

  2. 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

  3. Percentage of subjects requiring anti-VEGF injections over time [ Time Frame: 104 weeks ]
    Percentage of subjects requiring anti-VEGF injections over time

  4. Mean number of anti-VEGF injections over time [ Time Frame: 104 weeks ]
    Mean number of anti-VEGF injections over time

  5. Percentage of subjects without intraretinal fluid over time [ Time Frame: 104 weeks ]
    Percentage of subjects without intraretinal fluid over time

  6. Percentage of subjects without subretinal fluid over time [ Time Frame: 104 weeks ]
    Percentage of subjects without subretinal fluid over time


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

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
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): NCT03748784


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
Golden, Colorado, United States, 80401
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, South Carolina
Adverum Clinical Site
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Adverum Clinical Site
Nashville, Tennessee, United States, 37203
United States, Texas
Adverum Clinical Site
Abilene, Texas, United States, 79606
Adverum Clinical Site
Houston, Texas, United States, 77030
Adverum Clinical Site
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Adverum Biotechnologies, Inc.
Investigators
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Study Chair: OPTIC Medical Monitor Adverum Biotechnologies, Inc.
More Information
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Responsible Party: Adverum Biotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT03748784    
Other Study ID Numbers: ADVM-022-01
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: August 2023

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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 Neovascularizatio
ADVM-022
CNV
ADVM-022-01
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
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