Clinical trial NCT05179460: A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pigmentary Maculopathy
Pigmentary Retinopathy
Interstitial Cystitis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
measure: Clean Cohort: Incidence Rate of PM/PR/PPS
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Clean Cohort: Incidence Rate of PM/PR/Non-PPS
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Clean Cohort: Prevalence Rate of PM/PR/Any Cases
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Clean Cohort: Prevalence Rate of PM/PR/PPS
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Clean Cohort: Prevalence Rate of PM/PR/Non-PPS
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Overall Cohort: Incidence Rate of PM/PR/Any Cases
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Overall Cohort: Prevalence Rate of PM/PR/Any Cases
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Overall Cohort: Incidence Rate of PM/PR/PPS
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Overall Cohort: Prevalence Rate of PM/PR/PPS
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Overall Cohort: Number of PM/PR/PPS Cases Among the PM/PR/Any Cases
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Clean Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Clean Cohort: Change in VA in Relation to PM/PR/Any Cases
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Clean Cohort: Change in VA in Relation to PM/PR/PPS
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Clean Cohorts: Change in VA in Relation to PM/PR/Non-PPS
timeFrame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
measure: Overall Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Overall Cohort: Change in VA in Relation to PM/PR/Any Cases
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Overall Cohort: Change in VA in Relation to PM/PR/PPS
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Overall Cohort: Change in VA in Relation to PM/PR/Non-PPS
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Interstitial Cystitis (IC) Cohort: Incidence Rate of PM/PR/Any Cases Among the Participants with IC and No-Exposure to PPS
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: IC Cohort: Change in VA in Relation to PM/PR/Any Cases
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: IC Cohort: Change in VA Based on Age
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: IC Cohort: Change in VA Based on Sex
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: IC Cohort: Change in VA Based on Time Between the First and Last VA Measurement in Matched Cohorts
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Secondary outcomes:
measure: Demographic characteristics of Cohorts: Age
timeFrame: Baseline
measure: Demographic characteristics of Cohorts: Sex
timeFrame: Baseline
measure: Demographic characteristics of Cohorts: Race
timeFrame: Baseline
measure: Demographic characteristics of Cohorts: Ethnicity
timeFrame: Baseline
measure: Number of Participants with Comorbidities
timeFrame: Baseline
measure: Number of Participants who had Provider Characteristics
timeFrame: Baseline
measure: Overall Cohort: Distribution of International Classification of Diseases (ICD)-9/10 Codes
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
measure: Participant's Journey to PPS
timeFrame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Other outcomes:
Locations:
city: Titusville
country: United States
facility: Janssen R&D, LLC
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: