Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa Patients (ENVISION)
- Conditions
- Retinitis Pigmentosa
- Registration Number
- NCT06460844
- Lead Sponsor
- Ray Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Adults =18 years of age<br><br> - Informed consent obtained from the patient<br><br> - Clinical diagnosis of Retinitis Pigmentosa independent of causative mutation<br><br> - Study eye and fellow eye Best Corrected Visual Acuity meeting study criteria<br><br> - Presence of retinal ganglion cells and/or retinal nerve fiber layer on Spectral<br> Domain Optical Coherence Tomography testing at Screening confirmed by central image<br> reading center<br><br> - Adequate organ function and general good health<br><br>Exclusion Criteria:<br><br> - Participation in a clinical study (ocular or non-ocular) with an investigational<br> drug, agent, or therapy in the past six months<br><br> - Concurrent participation in another interventional clinical ocular study<br><br> - Prior receipt of any gene therapy (ocular or other), retinal implant, or ocular cell<br> therapy<br><br> - Pre-existing eye conditions in either eye that would preclude the planned treatment<br> or, in the opinion of the Investigator, are significant enough to interfere with the<br> interpretation of study endpoints or procedural complications<br><br> - Known steroid responders if their intraocular pressure was not able to be managed<br> effectively with topical pressure-lowering medications after prior use of steroid<br> medications<br><br> - Complicating systemic diseases; complicating systemic diseases include those in<br> which the disease itself, or the treatment for the disease, can alter ocular and/or<br> Central Nervous System (CNS) function (e.g., radiation treatment of the orbit;<br> leukemia with CNS/optic nerve involvement)<br><br> - Any immunological response dysfunction including, immuno-compromising diseases or<br> use of immunosuppressive medications, among others<br><br> - Cataract or other ocular (including refractive) surgery, intraocular and/or<br> peri-ocular injection in either eye within the prior four months (i.e., 120 days)<br> prior to screening<br><br> - Prior vitrectomy or aphakia in the study eye<br><br> - Known sensitivity to any component of the study treatment or contraindication to<br> medications planned for use in the peri-procedural period (e.g., povidone-iodine to<br> prep for intravitreal injection)<br><br> - Known contraindication to prophylactic steroid regimen<br><br> - Current pregnancy or breastfeeding<br><br> - Any other condition that would not allow the patient to complete follow-up<br> examinations during the study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events
- Secondary Outcome Measures
Name Time Method Best Corrected Visual Acuity (BCVA) at Month 6 and Month 12;Low Luminance Visual Acuity (LLVA) at Month 6 and Month 12;Multi luminance mobility at Month 6 and Month 12;Contrast Sensitivity at Month 6 and Month 12;Full-field static visual field testing at Month 6 and Month 12;Low Vision Quality of Life at Month 6 and Month 12