Observing visual function in adults with retinitis pigmentosa
A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)
Sumitomo Pharma America, Inc. · NCT06517940
This study looks at how vision changes over time in adults with severe retinitis pigmentosa to see which tests are most helpful and how patients feel about them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sumitomo Pharma America, Inc. (industry) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06517940 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the natural history of severe retinitis pigmentosa (RP) by evaluating visual assessments that individuals with low visual acuity can reliably perform. Over a 12-month period, approximately 12 adult subjects diagnosed with nonsyndromic RP will be enrolled to assess the annual decline in visual function. The study will also explore the sensitivity of various visual assessments to changes in visual function and evaluate the safety and tolerability of the assessment procedures. Additionally, patient-reported outcomes and experiences will be gathered to understand the relevance of these assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of nonsyndromic retinitis pigmentosa and low visual acuity.
Not a fit: Patients with other eye diseases or visual disorders that impair visual function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the progression of retinitis pigmentosa, potentially leading to improved management strategies for patients.
How similar studies have performed: While this study focuses on a specific aspect of retinitis pigmentosa, similar observational studies have provided valuable insights into disease progression and have shown success in understanding visual function in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Subject has a central visual field diameter (ie, excluding temporal islands) of \< 20 degrees in the worse eye as measured with the V4e stimulus using kinetic perimetry. Exclusion Criteria: * 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. * 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.
Where this trial is running
Boston, Massachusetts
- Mass Eye and Ear — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Clinical Research Medical Lead
- Email: ClinicalTrialDisclosure@sunovion.com
- Phone: 1-866-503-6351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinitis Pigmentosa, Retinitis Pigmentosa. Natural history