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This study examines the safety and how well the body tolerates RGX-314, a gene therapy, in patients with vision loss caused by neovascular age-related macular degeneration (AMD). It was open to patients aged 50 to 89 who had previously received anti-VEGF injections in the eye. It was conducted in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Patients ≥ 50 and ≤ 89 years with a diagnosis of subfoveal CNV (Choroidal neovascularization) secondary to AMD in the study eye receiving prior intravitreal anti-VEGF therapy. 2. BCVA (Best Corrected Visual Acuity) between ≤20/63 and ≥20/400 (≤63 and ≥19 Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters) for the first patient in each cohort followed by BCVA between ≤20/40 and ≥20/400 (≤73 and ≥19 ETDRS letters) for the rest of the cohort. 3. History of need for and response to anti-VEGF therapy. 4. Response to anti-VEGF at trial entry (assessed by SD-OCT (Spectral Domain Optical Coherence Tomography) at week 1) 5. Must be pseudophakic (status post cataract surgery) in the study eye. 6. AST (Aspartate aminotransferase)/ALT (Alanine aminotransferase) \< 2.5 × ULN (Upper limit of normal); TB (Total bilirubin) \< 1.5 × ULN; PT (Prothrombin time) \< 1.5 × ULN; Hb \> 10 g/dL (males) and \> 9 g/dL (females); Platelets \> 100 × 10\^3/µL; eGFR (Estimated glomerular filtration rate) \> 30 mL/min/1.73 m\^2 7. Must be willing and able to provide written, signed informed consent. Exclusion Criteria: 1. CNV or macular edema in the study eye secondary to any causes other than AMD. 2. Any condition preventing visual acuity improvement in the study eye, eg, fibrosis, atrophy, or retinal epithelial tear in the center of the fovea. 3. Active or history of retinal detachment in the study eye. 4. Advanced glaucoma in the study eye. 5. 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. 6. Presence of an implant in the study eye at screening (excluding intraocular lens). 7. Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within the past 6 months. 8. Uncontrolled hypertension (systolic blood pressure \[BP\] \>180 mmHg, diastolic BP \>100 mmHg) despite maximal medical treatment.