ADVM-022 Intravitreal Gene Therapy for Wet AMD
OPTIC
An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration
1 other identifier
interventional
30
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2018
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2018
CompletedFirst Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2022
CompletedAugust 8, 2023
August 1, 2023
3.6 years
November 19, 2018
August 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Type, severity, and incidence of ocular and systemic adverse events (AEs)
Type, severity, and incidence of ocular and systemic adverse events (AEs)
104 weeks
Secondary Outcomes (6)
Change in best corrected visual acuity (BCVA)
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
104 weeks
Mean number of anti-VEGF injections over time
104 weeks
Percentage of subjects without intraretinal fluid over time
104 weeks
- +1 more secondary outcomes
Study Arms (2)
Dose 1
EXPERIMENTAL6E11 vg of ADVM-022
Dose 2
EXPERIMENTAL2E11 vg of ADVM-022
Interventions
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Adverum Clinical Site
Bakersfield, California, 93309, United States
Adverum Clinical Site
Beverly Hills, California, 90211, United States
Adverum Clinical Site
Golden, Colorado, 80401, United States
Adverum Clinical Site
Deerfield Beach, Florida, 33064, United States
Adverum Clinical Site
Reno, Nevada, 89502, United States
Adverum Clinical Site
Philadelphia, Pennsylvania, 19107, United States
Adverum Clinical Site
West Columbia, South Carolina, 29169, United States
Adverum Clinical Site
Nashville, Tennessee, 37203, United States
Adverum Clinical Site
Abilene, Texas, 79606, United States
Adverum Clinical Site
Houston, Texas, 77030, United States
Adverum Clinical Site
The Woodlands, Texas, 77384, United States
Related Publications (1)
Khanani AM, Boyer DS, Wykoff CC, Regillo CD, Busbee BG, Pieramici D, Danzig CJ, Joondeph BC, Major JC Jr, Turpcu A, Kiss S. Safety and efficacy of ixoberogene soroparvovec in neovascular age-related macular degeneration in the United States (OPTIC): a prospective, two-year, multicentre phase 1 study. EClinicalMedicine. 2023 Dec 22;67:102394. doi: 10.1016/j.eclinm.2023.102394. eCollection 2024 Jan.
PMID: 38152412DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
OPTIC Medical Monitor
Adverum Biotechnologies, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 21, 2018
Study Start
November 14, 2018
Primary Completion
June 22, 2022
Study Completion
June 22, 2022
Last Updated
August 8, 2023
Record last verified: 2023-08