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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