Retinitis PigmentosaNCT06517940
A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)
An observational study of Retinitis Pigmentosa, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
The natural history in individuals with severe retinitis pigmentosa (RP) is variable and there remains an unmet need to better understand disease progression in this population. The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 24 Apr 2026
- Phase
- Observational
- 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
Study population: Retinitis pigmentosa subjects with low visual acuity
Who may be able to join
- Subject is able to provide written informed consent and is willing and able to comply with the protocol.
- Subject is ≥ 18 years of age at the time of informed consent.
- Subject has a clinical diagnosis of nonsyndromic retinitis pigmentosa.
- Subject is willing to consent to genetic testing, if not already done.
- Subject has BCVA in the worse eye between hand motion and 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/200 Snellen equivalent), inclusive at Screening.
- For subjects who are able to reliably perform kinetic perimetry in the opinion of the Investigator and the assessment provides accurate information, the central visual field diameter (ie, excluding temporal islands) of any visual field diameter is < 20 degrees in the worse eye as measured with the III-4e stimulus using Octopus 900 perimetry at Screening.
- On OCT, inner retinal layers are observed and are retained in the worse eye.
Who cannot join
- Subject has an eye disease or visual disorder other than retinitis pigmentosa that impairs visual function.
- Subject has any other eye condition, which in the opinion of the Investigator, would preclude an accurate evaluation at any time during the study.
- On OCT, subject has cystoid macular edema in the worse eye in the opinion of the Investigator or is currently receiving treatment for cystoid macular edema in the worse eye.
- Subject has unstable intraocular lens.
- Subject has a clinically significant epiretinal membrane based on the Investigator's judgment that will interfere with the assessments of visual function.
- Subject with a prior vitrectomy in the worse eye will be evaluated on a case-by-case basis by the Investigator to determine if the subject is eligible for the study.
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- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
- Subject has received treatment with any nonapproved, experimental, or investigational therapy in either eye (systemic, topical, intravitreal) and/or received treatment in an interventional clinical trial for an eye disease or disorder within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipates the need to receive treatment in an interventional clinical trial during their participation in this study.
- Subject has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an eye disease or disorder or anticipates the need for these therapies during their participation in this study.
- Subject has previously received LUXTURNA (voretigene neparvovec-rzyl) or anticipates the need for this therapy during their participation in this study.
- Subject is in the opinion of the Investigator unsuitable in any other way to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The natural history in individuals with severe retinitis pigmentosa (RP) is variable and there remains an unmet need to better understand disease progression in this population. The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to evaluate the annual decline of visual function in severe RP.
Read the detailed description
This is a 12-month, single-center, prospective observational study in adults with RP. Approximately 12 subjects will be enrolled into the Observation Period.
The primary objective of this study is to determine which visual assessments RP subjects with low visual acuity can reliably perform. Other objectives are 1) to determine which visual assessments are most sensitive to annual change in RP subjects with low visual acuity, 2) to evaluate adverse events, 3) to evaluate the safety and tolerability of study assessment procedures, and 4) to evaluate the subject's experience in this study, relevance of visual assessments and patient-reported outcome measures, and perception of improvement in visual function.
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis Pigmentosa. Natural history
- Medical subject headings
- Retinitis Pigmentosa
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability (test-retest variability within subjects)
Reliability (test-retest variability within subjects) on:
- Total visual area (degrees squared) on kinetic perimetry using III-4e stimulus (excluding temporal islands) (Time frame: 12 months)
- Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) Log of Minimum Angle of Resolution (LogMAR) equivalent (or Low Vision Test, as applicable) (Time frame: 12 months)
- Retinal light sensitivity on Full-field Stimulus Threshold test (Time frame: 12 months)
- Retinal sensitivity and fixation stability on microperimetry (Time frame: 12 months)
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 posted24 Jul 2024
- Study start3 Oct 2024
- Primary completion24 Apr 2026 (estimated)
- Study completion24 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517940
- Sponsor's protocol ID
- DE101111
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)
- ClinicalTrials.gov ID
- NCT06517940
- Acronym / sponsor ID
- DE101111
- Conditions
- Retinitis Pigmentosa
- Keywords
- Retinitis Pigmentosa. Natural history
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 24 Apr 2026 (estimated)
- First posted
- 24 Jul 2024 (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 natural history in individuals with severe retinitis pigmentosa (RP) is variable and there remains an unmet need to better understand disease progression in this population. The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to evaluate the annual decline of visual function in severe RP.
Detailed description
This is a 12-month, single-center, prospective observational study in adults with RP. Approximately 12 subjects will be enrolled into the Observation Period.
The primary objective of this study is to determine which visual assessments RP subjects with low visual acuity can reliably perform. Other objectives are 1) to determine which visual assessments are most sensitive to annual change in RP subjects with low visual acuity, 2) to evaluate adverse events, 3) to evaluate the safety and tolerability of study assessment procedures, and 4) to evaluate the subject's experience in this study, relevance of visual assessments and patient-reported outcome measures, and perception of improvement in visual function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retinitis pigmentosa subjects with low visual acuity
Key inclusion criteria (7 listed)
- Subject is able to provide written informed consent and is willing and able to comply with the protocol.
- Subject is ≥ 18 years of age at the time of informed consent.
- Subject has a clinical diagnosis of nonsyndromic retinitis pigmentosa.
- Subject is willing to consent to genetic testing, if not already done.
- Subject has BCVA in the worse eye between hand motion and 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/200 Snellen equivalent), inclusive at Screening.
Key exclusion criteria (11 listed)
- Subject has an eye disease or visual disorder other than retinitis pigmentosa that impairs visual function.
- Subject has any other eye condition, which in the opinion of the Investigator, would preclude an accurate evaluation at any time during the study.
- On OCT, subject has cystoid macular edema in the worse eye in the opinion of the Investigator or is currently receiving treatment for cystoid macular edema in the worse eye.
- Subject has unstable intraocular lens.
- Subject has a clinically significant epiretinal membrane based on the Investigator's judgment that will interfere with the assessments of visual function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability (test-retest variability within subjects)
Time frame: 12 months
Reliability (test-retest variability within subjects) on: * Total visual area (degrees squared) on kinetic perimetry using III-4e stimulus (excluding temporal islands) (Time frame: 12 months) * Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) Log of Minimum Angle of Resolution (LogMAR) equivalent (or Low Vision Test, as applicable) (Time frame: 12 months) * Retinal light sensitivity on Full-field Stimulus Threshold test (Time frame: 12 months) * Retinal sensitivity and fixation stability on microperimetry (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 27 Feb 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa, run by Sumitomo Pharma America, Inc. at 1 site 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability (test-retest variability within subjects) (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 27 Feb 2026.