Evaluating RTx-015 Injection for Eye Diseases
Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-015 in Patients With Retinitis Pigmentosa or Choroideremia (ENVISION)
This study is testing a new eye injection called RTx-015 to see if it can safely help people with retinitis pigmentosa or choroideremia improve their vision.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ray Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Beverly Hills, California and 2 other locations) |
| Trial ID | NCT06460844 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is designed to assess the safety and preliminary efficacy of RTx-015, an optogenetic gene therapy, in patients diagnosed with retinitis pigmentosa or choroideremia. Approximately 15 eligible patients will receive a single intravitreal injection of RTx-015 in one eye, followed by a 12-month monitoring period. The study will involve sequential enrollment into up to three dose cohorts, with each cohort starting with three patients. The trial aims to gather initial data on the treatment's safety profile and its potential effects on vision.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of retinitis pigmentosa or choroideremia and adequate retinal health.
Not a fit: Patients with prior gene therapy treatments or significant pre-existing eye conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with retinitis pigmentosa or choroideremia, potentially improving their vision.
How similar studies have performed: While this approach is novel, similar optogenetic therapies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥18 years of age * Informed consent obtained from the patient * Clinical diagnosis of Retinitis Pigmentosa independent of causative mutation OR Clinical diagnosis of Choroideremia with known causative mutation * Study eye and fellow eye Best Corrected Visual Acuity meeting study criteria * Presence of retinal ganglion cells and/or retinal nerve fiber layer on Spectral Domain Optical Coherence Tomography testing at Screening confirmed by central image reading center * Adequate organ function and general good health Exclusion Criteria: * Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent, or therapy in the past six months * Concurrent participation in another interventional clinical ocular study * Prior receipt of any gene therapy (ocular or other), retinal implant, or ocular cell therapy * Pre-existing eye conditions in either eye that would preclude the planned treatment or, in the opinion of the Investigator, are significant enough to interfere with the interpretation of study endpoints or procedural complications * Known steroid responders if their intraocular pressure was not able to be managed effectively with topical pressure-lowering medications after prior use of steroid medications * Complicating systemic diseases; complicating systemic diseases include those in which the disease itself, or the treatment for the disease, can alter ocular and/or Central Nervous System (CNS) function (e.g., radiation treatment of the orbit; leukemia with CNS/optic nerve involvement) * Any immunological response dysfunction including, immuno-compromising diseases or use of immunosuppressive medications, among others * Cataract or other ocular (including refractive) surgery, intraocular and/or peri-ocular injection in either eye within the prior four months (i.e., 120 days) prior to screening * Prior vitrectomy or aphakia in the study eye * Known sensitivity to any component of the study treatment or contraindication to medications planned for use in the peri-procedural period (e.g., povidone-iodine to prep for intravitreal injection) * Known contraindication to prophylactic steroid regimen * Current pregnancy or breastfeeding * Any other condition that would not allow the patient to complete follow-up examinations during the study
Where this trial is running
Beverly Hills, California and 2 other locations
- Retina Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
- UCI Alpha Clinic — Orange, California, United States (Recruiting)
- Retina Consultants of Texas Research Centers — Bellaire, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Executive Medical Director
- Email: clinicaltrials@raytherapeutics.com
- Phone: +1 858 617 8610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.