Retinitis Pigmentosa (RP)Phase 2/3PERCEPTNCT07901751
Study to Evaluate the Efficacy of a Single Intravitreal Injection of RTx-015 in Participants With Retinitis Pigmentosa (PERCEPT)
A Phase 2/3 study testing RTx-015 in people with Retinitis Pigmentosa (RP) and Inherited Retinal Diseases, run by Ray Therapeutics, Inc. at 14 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa (RP), Inherited Retinal Diseases
- What is being tested?
- RTx-015
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2026to Oct 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Not yet recruiting
RayTx Clinical Site
‘Aiea, Hawaii, 96701
- Recruiting
RayTx Clinical Site
Bakersfield, California, 93309
- Recruiting
RayTx Clinical Site
Beverly Hills, California, 90211
- Not yet recruiting
RayTx Clinical Site
Bloomfield, New Jersey, 07003
- Not yet recruiting
RayTx Clinical Site
Deerfield Beach, Florida, 33064
- Not yet recruiting
RayTx Clinical Site
Detroit, Michigan, 48201
- Not yet recruiting
RayTx Clinical Site
Edina, Minnesota, 55435
- Recruiting
RayTx Clinical Site
Greensboro, North Carolina, 27401
- Recruiting
RayTx Clinical Site
Mt. Pleasant, South Carolina, 29464
- Recruiting
RayTx Clinical Site
Oak Park, Illinois, 60304
- Not yet recruiting
RayTx Clinical Site
Phoenix, Arizona, 85020
- Recruiting
RayTx Clinical Site
Portland, Oregon, 97225
- Not yet recruiting
RayTx Clinical Site
San Antonio, Texas, 78240
- Not yet recruiting
RayTx Clinical Site
Santa Barbara, California, 93103
About this study
Official title: Phase 2/3, Double-masked, Randomized, Sham-controlled, Single Dose Study to Evaluate the Efficacy of a Single Intravitreal Injection of RTx-015 in Participants With Retinitis Pigmentosa (PERCEPT)
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).
Read the detailed description
In this Phase 2/3, double-masked study, approximately 60 eligible participants with RP will be enrolled and randomized to receive in the study eye either a single, unilateral intravitreal injection of lower dose RTx-015, higher dose RTx-015, or a sham injection. Participants who meet all eligibility criteria will be randomized in a 1:1:1 ratio. Participants will be followed for a total of 12 months.
- Being tested
- RTx-015, Sham Control
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTx-015Drug
Intravitreal injection
Sham ControlOther
Sham Control
| Study group | Role | What they receive |
|---|---|---|
| RTx-015 Lower Dose | Experimental | RTx-015 Lower Dose Receives: Drug: RTx-015 |
| RTx-015 Higher Dose | Experimental | RTx-015 Higher Dose Receives: Drug: RTx-015 |
| Sham Control | Sham comparator | Sham Control Receives: Other: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Change from baseline in kinetic visual field area at Month 12, comparing each of the 2 active treatment arms with the sham control arm.
Measured: 12 Months
Secondary outcomes (2)
Secondary Objective
Change from baseline in low luminance visual acuity (LLVA) at Month 12, comparing each of the 2 active treatment arms with the sham control arm.
Measured: 12 Months
Secondary Objective
Change from baseline in the ultra-low vision visual function questionnaire (ULV-VFQ) at Month 6, comparing each of the 2 active treatment arms with the sham control arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis Pigmentosa (RP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ray Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901751
- Sponsor's protocol ID
- RTx-015-RP-201
- Acronym
- PERCEPT
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not currently being shared as this investigational treatment has not received regulatory approval.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3, Double-masked, Randomized, Sham-controlled, Single Dose Study to Evaluate the Efficacy of a Single Intravitreal Injection of RTx-015 in Participants With Retinitis Pigmentosa (PERCEPT)
- ClinicalTrials.gov ID
- NCT07901751
- Acronym / sponsor ID
- PERCEPT / RTx-015-RP-201
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ray Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
In this Phase 2/3, double-masked study, approximately 60 eligible participants with RP will be enrolled and randomized to receive in the study eye either a single, unilateral intravitreal injection of lower dose RTx-015, higher dose RTx-015, or a sham injection. Participants who meet all eligibility criteria will be randomized in a 1:1:1 ratio. Participants will be followed for a total of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RTx-015 Lower Dose | Experimental | Drug: RTx-015RTx-015 Lower Dose |
| RTx-015 Higher Dose | Experimental | Drug: RTx-015RTx-015 Higher Dose |
| Sham Control | Sham comparator | Other: Sham ControlSham Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTx-015Intravitreal injection | Drug | RTx-015 Higher Dose, RTx-015 Lower Dose |
| Sham ControlSham Control | Other | Sham Control |
Primary outcome
Primary Objective
Time frame: 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.
2 secondary outcomes
Secondary Objective
Time frame: 12 Months
Secondary Objective
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. IPD is not currently being shared as this investigational treatment has not received regulatory approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RTx-015 in people with Retinitis Pigmentosa (RP) and Inherited Retinal Diseases, run by Ray Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Executive Medical Director (858-617-8610, clinicaltrials@raytherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.