Recruiting
Phase 2
Phase 3

Gene Therapy

Sponsor:

Ray Therapeutics, Inc.

Code:

NCT07901751

Conditions

Retinitis Pigmentosa (RP)

Inherited Retinal Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RTx-015

Sham Control

Study Details

Brief summary:

The purpose of this clinical trial is to evaluate the effectiveness and safety of a single injection into the eye of an investigational gene therapy in participants with retinitis pigmentosa (RP).

Conditions

Retinitis Pigmentosa (RP)

Inherited Retinal Diseases

Study ID

NCT07901751

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults ≥18 years of age at the time of informed consent.
  • Able and willing to provide written informed consent prior to any study-specific procedures, in accordance with ICH GCP and applicable regulations.
  • Clinical diagnosis of RP, regardless of the underlying genetic mutation
  • Baseline best corrected distance visual acuity (BCVA) in the study eye of LogMAR 1.0 and 2.7 inclusive (approximately 20/200 - 20/9000), measured monocularly at the ETF by certified, masked personnel using grating visual acuity with conversion to logMAR equivalents.
  • Presence of retinal ganglion cells and/or retinal nerve fiber layer on SD-OCT testing at Screening confirmed by central image reading center.
  • Adequate organ function and general good health

Exclusion Criteria:

  • Participation in another interventional clinical study (ocular or systemic) involving administration of an investigational drug, biologic, or device within 6 months prior to Screening
  • Planned participation in another interventional study during the course of this trial.
  • Prior receipt of any gene therapy (ocular or other), retinal implant, or ocular cell therapy in either eye
  • Presence of any pre-existing ocular condition in either eye that would preclude the planned intravitreal injection, Increase the risk of procedure-related complication, or interfere with interpretation of efficacy or safety outcomes, including hyperreflective loci/foci (HRF) on OCT imaging
  • Known or suspected steroid responders whose intraocular pressure could not be adequately controlled with topical pressure-lowering medications after prior use of steroid medications (ocular, periocular, or systemic).
  • Complicating systemic diseases; complicating systemic diseases include those in which the disease itself, or the treatment for the disease, can alter ocular and/or CNS function or confound study outcomes (e.g., prior radiation treatment of the orbit; leukemia with CNS/optic nerve involvement, uncontrolled hypertension, or similar conditions).
  • Known immunological response dysfunction including immuno-compromising diseases or use of immunosuppressive medications (other than physiologic corticosteroid replacement).
  • Positive infectious disease screen (hepatitis B, C, and/or Human Immunodeficiency Virus \[HIV\]).
  • Cataract or other ocular surgery (including refractive), 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 hypersensitivity 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 specified in the protocol.
  • Current pregnancy or breastfeeding.
  • Weighing less than 40 kg (88 pounds)
  • Any condition, including cognitive, mobility, or geographical limitations, that would prevent completion of required study visits or ETF assessments
  • Any condition that, in the opinion of the investigator or medical monitor, makes the participant unsuitable for the study or would interfere with the interpretation of study endpoints.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RTx-015 Lower Dose

RTx-015 Lower Dose

experimental: RTx-015 Higher Dose

RTx-015 Higher Dose

sham comparator: Sham Control

Sham Control

Interventions

RTx-015

Intravitreal injection

Sham Control

Sham Control

Primary outcome measure

  • Primary Objective [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Executive Medical Director

858-617-8610clinicaltrials@raytherapeutics.com

Locations

RayTx Clinical Site

Recruiting

Bakersfield, California, United States, 93309

RayTx Clinical Site

Recruiting

Beverly Hills, California, United States, 90211

RayTx Clinical Site

Recruiting

Oak Park, Illinois, United States, 60304

RayTx Clinical Site

Recruiting

Greensboro, North Carolina, United States, 27401

RayTx Clinical Site

Recruiting

Portland, Oregon, United States, 97225

RayTx Clinical Site

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

More Information

Sponsor

Ray Therapeutics, Inc.

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Ray Therapeutics, Inc. on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.