Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal … (NCT04704921) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
United States671 participantsStarted 2020-12-29
Plain-language summary
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). 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 (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.
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 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
. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC
✕. Any condition in the investigator's opinion that could limit VA improvement in the study eye
✕. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
✕. Advanced glaucoma or history of secondary glaucoma in the study eye
✕. 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 product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1