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ADVM-022 Gene Therapy for Wet AMD (OPTIC)

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ClinicalTrials.gov Identifier: NCT03748784
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Adverum Biotechnologies, Inc.

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 lifelong intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time 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 preserving the vision of patients. ADVM-022 is designed to reduce the current treatment burden and the adverse events (AEs) associated with chronic IVT injections.

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-escalation study will evaluate 3 dose levels in 18 subjects (6 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open-label, dose-escalation 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept

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
2E12 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 3
6E12 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




Primary Outcome Measures :
  1. Type, severity, and incidence of ocular and systemic adverse events (AEs) [ Time Frame: 24 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: 24 weeks ]
    Change in best corrected visual acuity (BCVA)

  2. Change in central retinal thickness (CRT measured by SD-OCT) [ Time Frame: 24 weeks ]
    Change in central retinal thickness (CRT measured by SD-OCT)

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

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



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
Criteria

Inclusion Criteria:

  • Age ≥ 50
  • Diagnosis of neovascular (wet) AMD
  • BCVA ETDRS Snellen equivalent between ≤20/40 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

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, 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
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 Director: Aaron Osborne, MBBS, MRCOphth Adverum Biotechnologies, Inc.

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Responsible Party: Adverum Biotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT03748784     History of Changes
Other Study ID Numbers: ADVM-022-01
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: March 2019

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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
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases