Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION)

Launched by RAY THERAPEUTICS, INC. · Jun 13, 2024

Keywords

ClinConnect Summary

The ENVISION clinical trial is studying a new treatment called RTx-015 injection for patients with Retinitis Pigmentosa, a genetic eye disease that affects vision. This is a Phase 1 study, which means it’s one of the first steps in testing the safety of this treatment in humans. The trial will involve about 9 adults who will receive a single injection of RTx-015 in one eye and will be monitored for 12 months to see how well the treatment works and if there are any side effects.

To participate, you need to be at least 18 years old and have a diagnosis of Retinitis Pigmentosa. Your eyesight in both eyes should meet certain criteria, and you must be generally healthy with normal organ function. However, if you have had recent eye surgeries, other significant eye conditions, or have participated in other clinical trials in the past six months, you may not be eligible. If you join the study, you’ll receive the injection and attend follow-up visits to track your progress. This trial is currently recruiting participants, so if you or someone you know is interested, it could be an opportunity to contribute to research in this area.

Gender

ALL

Eligibility 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