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Recruiting Phase 2/3

Study to Evaluate the Efficacy of a Single Intravitreal Injection of RTx-015 in Participants With Retinitis Pigmentosa (PERCEPT)

NCT07901751 · tracked via the Priya Life Science USA tracker
Phase
Phase 2/3
Started
2026-10
Last updated
2026-10-28

Condition(s) studied

Retinitis Pigmentosa (RP)Inherited Retinal Diseases

Investigational drug(s) / intervention(s)

RTx-015Sham Control

RTx-015: Intravitreal injection

Sham Control: Sham Control

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Primary Objective — 12 Months
    Change from baseline in kinetic visual field area at Month 12, comparing each of the 2 active treatment arms with the sham control arm.

Trial sites (14)

FacilityCityRegionStatus
RayTx Clinical Site Phoenix Arizona Not Yet Recruiting
RayTx Clinical Site Bakersfield California Recruiting
RayTx Clinical Site Beverly Hills California Recruiting
RayTx Clinical Site Santa Barbara California Not Yet Recruiting
RayTx Clinical Site Deerfield Beach Florida Not Yet Recruiting
RayTx Clinical Site ‘Aiea Hawaii Not Yet Recruiting
RayTx Clinical Site Oak Park Illinois Recruiting
RayTx Clinical Site Detroit Michigan Not Yet Recruiting
RayTx Clinical Site Edina Minnesota Not Yet Recruiting
RayTx Clinical Site Bloomfield New Jersey Not Yet Recruiting
RayTx Clinical Site Greensboro North Carolina Recruiting
RayTx Clinical Site Portland Oregon Recruiting
RayTx Clinical Site Mt. Pleasant South Carolina Recruiting
RayTx Clinical Site San Antonio Texas Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07901751 on ClinicalTrials.gov ↗ ← All trials in the USA