Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (NCT05407636) | Clinical Trial Compass
RecruitingPhase 3
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
United States714 participantsStarted 2022-01-13
Plain-language summary
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.
Who can participate
Age range50 Years – 89 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
✓. An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes
✓. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes
Exclusion criteria
✕. CNV or macular edema in the study eye secondary to any causes other than AMD
✕
What they're measuring
1
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Timeframe: At Week 54
2
Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs
✕. 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
✕. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
✕. History of intraocular surgery in the study eye within 12 weeks prior to randomization
✕. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6