ADVM-022 Intravitreal Gene Therapy for Wet AMD
- Conditions
- Wet Age-related Macular DegenerationNeovascular Age-related Macular Degeneration
- Interventions
- Biological: ADVM-022
- Registration Number
- NCT03748784
- Lead Sponsor
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose 1 ADVM-022 6E11 vg of ADVM-022 Dose 2 ADVM-022 2E11 vg of ADVM-022
- Primary Outcome Measures
Name Time Method Type, severity, and incidence of ocular and systemic adverse events (AEs) 104 weeks Type, severity, and incidence of ocular and systemic adverse events (AEs)
- Secondary Outcome Measures
Name Time Method Change in central subfield thickness (CST) and macular volume measured by SD-OCT 104 weeks Change in central subfield thickness (CST) and macular volume measured by SD-OCT
Percentage of subjects without intraretinal fluid over time 104 weeks Percentage of subjects without intraretinal fluid over time
Change in best corrected visual acuity (BCVA) 104 weeks Change in best corrected visual acuity (BCVA)
Mean number of anti-VEGF injections over time 104 weeks Mean number of anti-VEGF injections over time
Percentage of subjects requiring anti-VEGF injections over time 104 weeks Percentage of subjects requiring anti-VEGF injections over time
Percentage of subjects without subretinal fluid over time 104 weeks Percentage of subjects without subretinal fluid over time
Trial Locations
- Locations (1)
Adverum Clinical Site
🇺🇸The Woodlands, Texas, United States