Cellular Scale Measures of Short-Term Retinal Atrophy Progression

December 1, 2022 updated by: Kristen Bowles Johnson, Indiana University

Cellular Scale Characterization of the Retinal Pigment Epithelium-Photoreceptor Complex in Pentosan Polysulfate Sodium Toxicity

Our goal is to determine the cellular scale changes that occur in subjects who have disease progression due to pentosan polysulfate sodium toxicity

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine the formation and progression of retinal changes caused by pentosan polysulfate sodium toxicity. To do this, we will measure how single cone photoreceptors respond to light in regions of the retina that are affected by pentosan polysulfate sodium toxicity. We will also measure how the retinal pigment epithelium, a layer of cells vital to photoreceptor health, change in shape and size over time.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristen Bowles Johnson, O.D.,Ph.D.
  • Phone Number: 812-855-8991
  • Email: kbowlesj@iu.edu

Study Locations

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Recruiting
        • Indiana University School of Optometry
        • Contact:
          • Kristen Bowles Johnson, O.D.,Ph.D.
          • Phone Number: 812-855-8991
          • Email: kbowlesj@iu.edu
        • Principal Investigator:
          • Kristen Bowles Johnson, O.D.,Ph.D.
        • Principal Investigator:
          • Don Miller, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited through IU school of optometry affiliated clinics, IU health clinics, or their eye care provider.

Description

Inclusion Criteria:

  • A history of pentosan polysulfate sodium (Elmiron) usage for 5+ years
  • Documented retinal findings that are associated with pentosan polysulfate sodium toxicity

Exclusion Criteria:

  • Presence of cataract or ocular media opacity that impedes retinal imaging
  • If standard pupil dilation imposes a risk to ocular health
  • Documented severe dry eye on ocular exam
  • High refractive error (more than -/+ 6 Diopters)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
toxic maculopathy
Subjects with a history of 5+ years of Pentosan Polysulfate sodium use and with retinal findings associated with Pentosan polysulfate sodium toxicity on fundus exam
Device: Adaptive optics imaging
adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome of this study is to develop new biomarkers of retinal atrophy progression due to pentosan polysulfate sodium toxicity.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Estimate)

December 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPSTox1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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