Status:
COMPLETED
RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)
Lead Sponsor:
AbbVie
Conditions:
Neovascular Age-related Macular Degeneration
Wet Macular Degeneration
Eligibility:
All Genders
50-89 years
Phase:
PHASE2
Brief Summary
RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (nAMD) also referred to as Wet AMD. Wet AMD is characterized by loss...
Detailed Description
Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have signi...
Eligibility Criteria
Inclusion
- Males or females, aged ≥ 50 years and ≤ 89 years.
- An Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA-letter score between ≤ 78 and ≥ 40 in the study eye at Screening.
- Diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration in the study eye previously treated with anti-VEGF.
- Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry.
- Willing and able to provide written, signed informed consent for this study.
- Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye.
Exclusion
- CNV or macular edema in the study eye secondary to any causes other than AMD.
- Subfoveal fibrosis or atrophy in study eye.
- Any condition in the investigator's opinion that could limit visual acuity improvement in the study eye.
- Active or history of retinal detachment or retinal tear in the study eye.
- Advanced glaucoma in the study eye.
- Prior treatment with gene therapy.
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04832724
Start Date
February 22 2021
End Date
March 18 2024
Last Update
September 5 2024
Active Locations (13)
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1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
2
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, United States, 85351
3
Retina Consultants of San Diego
San Diego, California, United States, 92064
4
California Retina Consultants
Santa Barbara, California, United States, 93103