Pigmentary MaculopathyNCT05179460
A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
An observational study of Pigmentary Maculopathy and Pigmentary Retinopathy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pigmentary Maculopathy, Pigmentary Retinopathy, Interstitial Cystitis
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to 20 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is derived from the United States-based electronic databases, including the Intelligent Research in Sight (IRIS) Registry, American Urological Association Quality (AQUA) Registry, and Komodo Health claims. The selection of the study participants and cohort creation will be determined by the inclusion and exclusion criteria.
Who may be able to join
- 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
Who cannot join
- Evaluated based on the Komodo database. Participants will be excluded from the study if they have no information on age or sex (or both)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Medical subject headings
- Retinitis Pigmentosa, Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clean Cohort | Clean cohort refers to cohort of participants who had their first documented exposure to pentosan polysulfate sodium (PPS; Elmiron) on or after 22 May 2018 and who are assumed to have had shorter exposure (the earliest available data based on the linked database between the IRIS registry and Komodo database in this study). | |
| Overall Cohort | Overall cohort refers to cohort of participants who had their first documented exposure to PPS (Elmiron) any time beginning 01 January 2015 and who are assumed to have relatively longer exposure (the earliest available data based on the linked database between the intelligent research in sight (IRIS) registry and Komodo database in this study). | |
| Interstitial Cystitis (IC) Cohort | IC cohort refers to cohort of participants who had at least one IC diagnosis beginning 01 January 2015 and had no documented exposure to PPS based on the records from the Komodo database (the earliest available data based on the linked database between the IRIS registry and Komodo database in this study). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clean Cohort: Incidence Rate of Pigmentary Maculopathy (PM)/ Pigmentary Retinopathy (PR)/Any Cases
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Incidence Rate of PM/PR/PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Incidence Rate of PM/PR/Non-PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Prevalence Rate of PM/PR/Any Cases
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Prevalence Rate of PM/PR/PPS
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Prevalence Rate of PM/PR/Non-PPS
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants not exposed to PPS).
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Overall Cohort: Incidence Rate of PM/PR/Any Cases
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Prevalence Rate of PM/PR/Any Cases
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Incidence Rate of PM/PR/PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Prevalence Rate of PM/PR/PPS
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Number of PM/PR/PPS Cases Among the PM/PR/Any Cases
Number of PM/PR/PPS cases among the PM/PR/any cases will be reported.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Clean Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than [<] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) greater than or equal to (>=) 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Change in VA in Relation to PM/PR/Any Cases
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Change in VA in Relation to PM/PR/PPS
Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohorts: Change in VA in Relation to PM/PR/Non-PPS
Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Overall Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than [<] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) greater than or equal to (>=) 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Change in VA in Relation to PM/PR/Any Cases
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Change in VA in Relation to PM/PR/PPS
Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Change in VA in Relation to PM/PR/Non-PPS
Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Interstitial Cystitis (IC) Cohort: Incidence Rate of PM/PR/Any Cases Among the Participants with IC and No-Exposure to PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases per number of person-years time at risk.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA in Relation to PM/PR/Any Cases
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA Based on Age
Change in VA based on age among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA Based on Sex
Change in VA based on sex among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA Based on Time Between the First and Last VA Measurement in Matched Cohorts
Change in VA based on time between the first and last VA measurement in matched cohorts among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Secondary outcomes (8)
Demographic characteristics of Cohorts: Age
Demographic characteristics of cohorts (age) will be reported.
Measured: Baseline
Demographic characteristics of Cohorts: Sex
Demographic characteristics of cohorts (sex) will be reported.
Measured: Baseline
Demographic characteristics of Cohorts: Race
Demographic characteristics of cohorts (race including Asian, black or African American, other, White or Caucasian) will be reported.
Measured: Baseline
Demographic characteristics of Cohorts: Ethnicity
Demographic characteristics of cohorts (ethnicity including Hispanic and non-Hispanic) will be reported.
Measured: Baseline
Number of Participants with Comorbidities
Number of participants with general comorbidities (diabetes, hypertension, hypercholesterolemia, vaginitis, urinary tract infection [UTI], detrusor instability, urge incontinence, and overactive bladder, autoimmune disease, Malignant tumor(s) of head and neck [plus documentation of radiation therapy] and Radiation cystitis) and ocular comorbidities (diabetic retinopathy, diabetic macular edema, optic neuropathy, glaucoma, glaucoma-related procedure, cataract [diagnosis], cataract [procedure]) will be reported.
Measured: Baseline
Number of Participants who had Provider Characteristics
Number of participants who had provider characteristics (treating provider specialty [retina specialist, non-retina specialist, general ophthalmologist, optometrist]; rural or non-rural location of index practice [rural/non-rural; United States Department of Agriculture Economic research service 2010 classification]) will be reported.
Measured: Baseline
Overall Cohort: Distribution of International Classification of Diseases (ICD)-9/10 Codes
ICD-9/10 codes are compared among the participants who are exposed to PPS will be reported.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Participant's Journey to PPS
Participant's journey to PPS is defined as the sequence of medications and other interventions the participant received before and after receiving PPS.
Measured: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start26 Oct 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pigmentary MaculopathyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179460
- Sponsor's protocol ID
- CR109142
- Other IDs
- RWJ800077ICS4001
- Status last verified
- Jun 2025
- First submitted
- 10 Dec 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan Z, Vaughan S, Jeffcoat C, Hu P, Yuson R, Fife D, Borkar D. Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. PLoS One. 2025 Jan 9;20(1):e0313497. doi: 10.1371/journal.pone.0313497. eCollection 2025.
PubMed 39787060
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-authorization Safety Study and Real-world Evaluation of the Use of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
- ClinicalTrials.gov ID
- NCT05179460
- Acronym / sponsor ID
- CR109142
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clean Cohort | – | –Clean cohort refers to cohort of participants who had their first documented exposure to pentosan polysulfate sodium (PPS; Elmiron) on or after 22 May 2018 and who are assumed to have had shorter exposure (the earliest available data based on the linked database between the IRIS registry and Komodo database in this study). |
| Overall Cohort | – | –Overall cohort refers to cohort of participants who had their first documented exposure to PPS (Elmiron) any time beginning 01 January 2015 and who are assumed to have relatively longer exposure (the earliest available data based on the linked database between the intelligent research in sight (IRIS) registry and Komodo database in this study). |
| Interstitial Cystitis (IC) Cohort | – | –IC cohort refers to cohort of participants who had at least one IC diagnosis beginning 01 January 2015 and had no documented exposure to PPS based on the records from the Komodo database (the earliest available data based on the linked database between the IRIS registry and Komodo database in this study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is derived from the United States-based electronic databases, including the Intelligent Research in Sight (IRIS) Registry, American Urological Association Quality (AQUA) Registry, and Komodo Health claims. The selection of the study participants and cohort creation will be determined by the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Evaluated based on the Komodo database. Participants will be excluded from the study if they have no information on age or sex (or both)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clean Cohort: Incidence Rate of Pigmentary Maculopathy (PM)/ Pigmentary Retinopathy (PR)/Any Cases
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Clean Cohort: Incidence Rate of PM/PR/PPS
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Clean Cohort: Incidence Rate of PM/PR/Non-PPS
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Clean Cohort: Prevalence Rate of PM/PR/Any Cases
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Clean Cohort: Prevalence Rate of PM/PR/PPS
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Clean Cohort: Prevalence Rate of PM/PR/Non-PPS
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants not exposed to PPS).
Overall Cohort: Incidence Rate of PM/PR/Any Cases
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Overall Cohort: Prevalence Rate of PM/PR/Any Cases
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Overall Cohort: Incidence Rate of PM/PR/PPS
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium [PPS]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Overall Cohort: Prevalence Rate of PM/PR/PPS
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Overall Cohort: Number of PM/PR/PPS Cases Among the PM/PR/Any Cases
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Number of PM/PR/PPS cases among the PM/PR/any cases will be reported.
Clean Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than [<] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) greater than or equal to (>=) 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Clean Cohort: Change in VA in Relation to PM/PR/Any Cases
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Clean Cohort: Change in VA in Relation to PM/PR/PPS
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Clean Cohorts: Change in VA in Relation to PM/PR/Non-PPS
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Overall Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than [<] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) greater than or equal to (>=) 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Overall Cohort: Change in VA in Relation to PM/PR/Any Cases
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Overall Cohort: Change in VA in Relation to PM/PR/PPS
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Overall Cohort: Change in VA in Relation to PM/PR/Non-PPS
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
Interstitial Cystitis (IC) Cohort: Incidence Rate of PM/PR/Any Cases Among the Participants with IC and No-Exposure to PPS
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases per number of person-years time at risk.
IC Cohort: Change in VA in Relation to PM/PR/Any Cases
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
IC Cohort: Change in VA Based on Age
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA based on age among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
IC Cohort: Change in VA Based on Sex
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA based on sex among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
IC Cohort: Change in VA Based on Time Between the First and Last VA Measurement in Matched Cohorts
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Change in VA based on time between the first and last VA measurement in matched cohorts among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to <1 line of worsening or improvement, considered not clinically meaningful); b) 1 to <3 lines of worsening; c) >= 3 lines of worsening; d) 1 to <3 lines of improvement; e) >= 3 lines of improvement.
8 secondary outcomes
Demographic characteristics of Cohorts: Age
Time frame: Baseline
Demographic characteristics of Cohorts: Sex
Time frame: Baseline
Demographic characteristics of Cohorts: Race
Time frame: Baseline
Demographic characteristics of Cohorts: Ethnicity
Time frame: Baseline
Number of Participants with Comorbidities
Time frame: Baseline
Number of Participants who had Provider Characteristics
Time frame: Baseline
Overall Cohort: Distribution of International Classification of Diseases (ICD)-9/10 Codes
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Participant's Journey to PPS
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 39787060Yuan Z, Vaughan S, Jeffcoat C, Hu P, Yuson R, Fife D, Borkar D. Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium. PLoS One. 2025 Jan 9;20(1):e0313497. doi: 10.1371/journal.pone.0313497. eCollection 2025.
- Redacted CSR synopsis-RWJ800077ICS4001Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pigmentary Maculopathy and Pigmentary Retinopathy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clean Cohort: Incidence Rate of Pigmentary Maculopathy (PM)/ Pigmentary Retinopathy (PR)/Any Cases (time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.