CompletedNot Applicable

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

United States2 participantsStarted 2021-10-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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: * 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 Exclusion Criteria: \- Evaluated based on the Komodo database. Participants will be excluded from the study if they have no information on age or sex (or both)

What they're measuring

Clean Cohort: Incidence Rate of Pigmentary Maculopathy (PM)/ Pigmentary Retinopathy (PR)/Any Cases

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Incidence Rate of PM/PR/PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Incidence Rate of PM/PR/Non-PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Prevalence Rate of PM/PR/Any Cases

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Prevalence Rate of PM/PR/PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Prevalence Rate of PM/PR/Non-PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Overall Cohort: Incidence Rate of PM/PR/Any Cases

Timeframe: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined

Trial details

NCT IDNCT05179460

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-05-20

View on ClinicalTrials.gov More Pigmentary Maculopathy trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clean Cohort: Incidence Rate of Pigmentary Maculopathy (PM)/ Pigmentary Retinopathy (PR)/Any Cases

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Incidence Rate of PM/PR/PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Incidence Rate of PM/PR/Non-PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Prevalence Rate of PM/PR/Any Cases

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Prevalence Rate of PM/PR/PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Clean Cohort: Prevalence Rate of PM/PR/Non-PPS

Timeframe: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined

Overall Cohort: Incidence Rate of PM/PR/Any Cases

Timeframe: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined