Neovascular Age-related Macular Degeneration Clinical Trial
— OPTICOfficial title:
An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration
Verified date | August 2023 |
Source | Adverum Biotechnologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 22, 2022 |
Est. primary completion date | June 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Adverum Clinical Site | Abilene | Texas |
United States | Adverum Clinical Site | Bakersfield | California |
United States | Adverum Clinical Site | Beverly Hills | California |
United States | Adverum Clinical Site | Deerfield Beach | Florida |
United States | Adverum Clinical Site | Golden | Colorado |
United States | Adverum Clinical Site | Houston | Texas |
United States | Adverum Clinical Site | Nashville | Tennessee |
United States | Adverum Clinical Site | Philadelphia | Pennsylvania |
United States | Adverum Clinical Site | Reno | Nevada |
United States | Adverum Clinical Site | The Woodlands | Texas |
United States | Adverum Clinical Site | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Adverum Biotechnologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in best corrected visual acuity (BCVA) | Change in best corrected visual acuity (BCVA) | 104 weeks | |
Secondary | Change in central subfield thickness (CST) and macular volume measured by SD-OCT | Change in central subfield thickness (CST) and macular volume measured by SD-OCT | 104 weeks | |
Secondary | Percentage of subjects requiring anti-VEGF injections over time | Percentage of subjects requiring anti-VEGF injections over time | 104 weeks | |
Secondary | Mean number of anti-VEGF injections over time | Mean number of anti-VEGF injections over time | 104 weeks | |
Secondary | Percentage of subjects without intraretinal fluid over time | Percentage of subjects without intraretinal fluid over time | 104 weeks | |
Secondary | Percentage of subjects without subretinal fluid over time | Percentage of subjects without subretinal fluid over time | 104 weeks |
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