A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ATMOSPHERE)
- Sponsor: Regenxbio Inc.
- Principal Investigator: Jonathan Chang, MD
- Study Coordinator: Kelly Boyd
Study Objective:
To evaluate the efficacy and safety of RGX-314 gene therapy in participants with neovascular age-related macular degeneration (nAMD).
Study Design:
Subjects will receive RGX-314 via subretinal delivery one time (high or low dose) or ranibizumab.
Inclusion Criteria:
- Age ≥ 50 years and ≤ 89 years
- An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
- Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
- Must be pseudophakic (at least 12 weeks post cataract surgery) in the study eye.
- Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
Exclusion Criteria:
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye
- Any condition in the investigator’s opinion that could limit VA improvement in the study eye
- Active or history of retinal detachment in the study eye
- Uncontrolled glaucoma in the study eye
- History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1
- History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
- Prior treatment with gene therapy.
- Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
Contact Kelly Boyd with questions at (608) 265-4589
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