A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
Completed
Conditions studied: Pigmentary Maculopathy, Pigmentary Retinopathy, Interstitial Cystitis
In brief
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.
Key facts
- Study ID
- NCT05179460
- Run by
- Janssen Research & Development, LLC
- People needed
- 2
- Starts
- 2021-10-26
- Expected to finish
- 2022-05-20
- Last updated by the study team
- 2025-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must have at least 6 months baseline information prior to index date (this may apply to the relevant databases, if the study participants are identified and the outcomes are ascertained via multiple linked data source) For the pentosan polysulfate sodium (PPS) Cohort
- Participants must have records in both the intelligent research in sight (IRIS) database and the closed claims portion of the Komodo claims database and have at least one record of PPS dispensing For the interstitial cystitis (IC) Cohort not exposed to PPS
- Participants must have records in both the IRIS database and the closed claims portion of the claims database; have at least one diagnosis of IC; and have no record of PPS dispensing
You may not qualify if…
- Evaluated based on the Komodo database. Participants will be excluded from the study if they have no information on age or sex (or both)
Where it is running
- Janssen R&D, LLC — Titusville, New Jersey, United States
Full record on ClinicalTrials.gov
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