A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP) (NCT06517940) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)
United States12 participantsStarted 2024-10-03
Plain-language 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 evaluate the annual decline of visual function in severe RP.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reliability (test-retest variability within subjects)