A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP) (NCT06517940) | Clinical Trial Compass
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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 range18 Years
SexALL
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Inclusion Criteria:
* Subject is able to provide written informed consent and is willing and able to comply with the protocol.
* Subject is ā„ 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 clinicallyā¦
What they're measuring
1
Reliability (test-retest variability within subjects)