Clinical Trial Search

Primary: In Eyes With VA Assessment Made ≤1 Year After Onset of Symptoms: Proportion of Eyes With Clinically Relevant Recovery (CRR) of VA (Measured by Change in ETDRS Letters)…

Primary: Double Masked Period: Incidence of Ocular TEAEs — 3; 8; 1; 3 eyes

Primary: Number of Treatment Related Adverse Events — 1; 1; 1; 5 Participants

Primary: The Best Corrected Visual Acuity(BCVA) — 1.40; 1.69; 1.36; 1.58 logMAR

Primary: Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 48 — 0.380; 0.392 LogMAR — p=0.8890

Primary: Overall Safety of Adeno-Associated Virus Vector (AAV-OPTIRPE65) - Number of Participants With a Safety Event — 0; 0; 1; 0 Participants

Primary: The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants. — 0.2; -11.3 ETDRS Letters

Primary: Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 48 — -0.219; -0.211 LogMAR — p=0.8783

Primary: Change in Anthropometric Measures Over Time — 1.97; -0.61; 1.39; 1.22 Z-score

Primary: Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements — 264.3; 273.3; 276.2 micro-ohms

Primary: Change From Baseline in Visual Acuity at 9 Month — -0.0574; 0.0535 LogMAR

Primary: Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit — 15; 7; 9; 6 EDTRS Letters

Primary: Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared) — 563.08…

Primary: Number of Participants Experiencing Ocular or Non-ocular Adverse Events — 6; 6 participants

Primary: Change From Baseline of the Best Corrected Visual Acuity (BCVA) Reported With Log of the Minimal Angle of Resolution (LogMAR) at 1.5 Years Post-treatment, in the Second…

Primary: Correlation Coefficient Between HEP and OVF Mean Deviation (MD) — -.86; -.37 Pearson's correlation coefficient

Primary: Number of Adverse Events at Six Months Post-Implantation — 10 Adverse Events

Primary: Charcot Marie Tooth Neuropathy Score — 25.67; 20.22 scores on a scale

Primary: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age — 0.01; 0.01; 0.03; 0.12 incidence rate per 1000 person-years

Primary: Blood Oxygenation at the Optic Nerve Head — 60.8; 65.3 percentage of oxygen saturation

Primary: Number of Participants Meeting the Primary Outcome Defined as Any of the Below Events Occurring During the 6 Weeks Following Administration, at Least Possibly Related to…

Primary: Link Between Lack of Word and Presbycusis — 38; 38.5; 23; 21.5 score on a scale

Primary: Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD) — 44; 37 participants

Primary: Rate of LOSS of 31 Hertz Cone Electroretinographic Function — 0.028; 0.022 log microvolts/year — p=0.30

Primary: Frequency and Severity of Ocular Adverse Events in the Treatment and Contralateral Eyes — 6; 5 Participants

Primary: Number of Participants With Change/Improvement Visual Acuity From the Beseline — 28; 3; 5 Participants

Primary: Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 — 128.1; 130.5; 89.5; 88.0 µm

Primary: Change in Visual Acuity — 4; 3 lines change in Snellen chart

Primary: Number of Participants Meeting the Primary Outcome Defined as Any of the Below Events Occurring During the 6 Weeks Following Administration, at Least Possibly Related to…

Primary: Number of Patients With Donor Cell Engraftment — 26 Participants