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Post-authorization Safety Study and Real-world Evaluation of the Use of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
The purpose of this study is to evaluate incidence and prevalence rates of the study endpoints (pigmentary maculopathy \[PM\]/ pigmentary retinopathy \[PR\]/Any, PM/PR/ pentosan polysulfate sodium \[PPS\], and PM/PR/Non-PPS) in relation to PPS exposure, and in participants with interstitial cystitis (IC) but not exposed to PPS; changes in visual acuity (VA) over time; participant treatment journey leading to PPS treatment, and potential risk factors associated with the occurrence of PM/PR/PPS.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Janssen R&D, LLC
Titusville, New Jersey, United States
Start Date
October 26, 2021
Primary Completion Date
May 20, 2022
Completion Date
May 20, 2022
Last Updated
June 26, 2025
2
ACTUAL participants
Lead Sponsor
Janssen Research & Development, LLC
NCT07391306
NCT05726786
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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