NCT05179460

A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy

Post-authorization Safety Study and Real-world Evaluation of the Use of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pigmentary Maculopathy
• Pigmentary Retinopathy
• Interstitial Cystitis

Timeline

• Start date: 2021-10-26
• Primary completion: 2022-05-20
• Completion: 2022-05-20
• First posted: 2022-01-05
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States