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 range

18 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

ALL

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