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Not recruiting
Phase 1

RTx-015

Sponsor:

Ray Therapeutics, Inc.

Code:

NCT06460844

Conditions

Retinitis Pigmentosa

Choroideremia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RTx-015

Study Details

Brief summary:

A Phase 1, open-label, non-randomized, dose-escalation study, where approximately 18 eligible patients with retinitis pigmentosa or choroideremia will be enrolled sequentially in up to 4 dose cohorts of RTx-015. Enrolled patients will receive a single, unilateral intravitreal injection of RTx-015 in the study eye at Visit 3 (Day 0) and be followed for a total of 5 years.

Conditions

Retinitis Pigmentosa

Choroideremia

Study ID

NCT06460844

Start date

Aug 27, 2024

Status verified date

Jun, 2025

Completion date

Oct, 2030

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Low Dose RTx-015

Single intravitreal injection of low dose RTx-015

experimental: Middle Dose RTx-015

Single intravitreal injection of middle dose RTx-015

experimental: High Dose RTx-015

Single intravitreal injection of high dose RTx-015

experimental: Higher Dose RTx-015

Single intravitreal injection of higher dose RTx-015

Interventions

RTx-015

Intravitreal injection using gene therapy to deliver an optogenetic gene to the eye. Cells in the retina use this Optogenetic gene to make a protein that responds to light.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Executive Medical Director

+1 858 617 8610clinicaltrials@raytherapeutics.com

Locations

Retina Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Contacts

David Boyer, MD

310-289-2478

Principal Investigator:

David Boyer, MD

UCI Alpha Clinic

Recruiting

Orange, California, United States, 92868

Contacts

UCI Alpha Clinic

(949) 824-3990alphaclinic@hs.uci.edu

UPMC Vision Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15221

Contacts

1622 Locust Street, 5th floor

412-642-7888

Retina Consultants of Texas Research Centers

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Jaclyn Henderson, MS, CCRP

713.524.3434jaclyn.henderson@retinaconsultantstexas.com

More Information

Sponsor

Ray Therapeutics, Inc.

Last update posted

Jun 13, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Ray Therapeutics, Inc. on 2025-06-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.