Status:
COMPLETED
ADVM-022 Intravitreal Gene Therapy for Wet AMD
Lead Sponsor:
Adverum Biotechnologies, Inc.
Conditions:
Wet Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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 cau...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03748784
Start Date
November 14 2018
End Date
June 22 2022
Last Update
August 8 2023
Active Locations (11)
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1
Adverum Clinical Site
Bakersfield, California, United States, 93309
2
Adverum Clinical Site
Beverly Hills, California, United States, 90211
3
Adverum Clinical Site
Golden, Colorado, United States, 80401
4
Adverum Clinical Site
Deerfield Beach, Florida, United States, 33064