Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-89
SponsorAbbVie

About this trial

ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) 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-vascular endothelial growth factor (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. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

Eligibility criteria

Qualifiers

Age ≥ 50 years and ≤ 89 years

An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye

Diagnosis of subfoveal choroidal neovascularization (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

Disqualifiers

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

Advanced glaucoma or history of secondary glaucoma in the study eye

Trial design

Treatments tested in this trial

  • ABBV-RGX-314 Dose 1
  • ABBV-RGX-314 Dose 2
  • Aflibercept (EYLEA®)

Treatment groups

714 Participants
are divided into 3 treatment groups

Sponsors and collaborators

AbbVie

Lead sponsor

REGENXBIO Inc.

Collaborator