NCT07901751 Study to Evaluate the Efficacy of a Single Intravitreal Injection of RTx-015 in Participants With Retinitis Pigmentosa (PERCEPT)
| NCT ID | NCT07901751 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Ray Therapeutics, Inc. |
| Condition | Retinitis Pigmentosa (RP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-10 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-10 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07901751 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Retinitis Pigmentosa (RP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07901751 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07901751 currently recruiting?
Yes, NCT07901751 is actively recruiting participants. Contact the research team at clinicaltrials@raytherapeutics.com for enrollment information.
Where is the NCT07901751 trial being conducted?
This trial is being conducted at Phoenix, United States, Bakersfield, United States, Beverly Hills, United States, Santa Barbara, United States and 10 additional locations.
Who is sponsoring the NCT07901751 clinical trial?
NCT07901751 is sponsored by Ray Therapeutics, Inc.. The trial plans to enroll 60 participants.