Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)

  • STATUS
    Recruiting
  • End date
    Mar 16, 2024
  • participants needed
    300
  • sponsor
    Regenxbio Inc.
Updated on 16 May 2022
vegf
gene therapy
vascular endothelial growth factor
ranibizumab
lucentis
anti-vegf therapy
macular degeneration
retinal diseases

Summary

RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. 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 significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. RGX-314 is being developed as a potential one-time treatment for wet AMD.

Description

This randomized, partially masked, controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 relative to an active comparator. The primary endpoint of this study is mean change in best-corrected visual acuity (BCVA) of RGX-314 relative to ranibizumab. Approximately 300 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

Details
Condition AMD, nAMD, Wet Age-related Macular Degeneration, wAMD, Wet AMD, CNV
Treatment RGX-314, Ranibizumab (LUCENTIS®)
Clinical Study IdentifierNCT04704921
SponsorRegenxbio Inc.
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

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 postcataract surgery) in the study eye
Willing and able to provide written, signed informed consent for this study
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
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