Cellular Scale Measures of Short-Term Retinal Atrophy Progression

Interstitial Cystitis, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05643157
• Other study ID #: PPSTox1
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2022
• Source: Indiana University
• Contact: Kristen Bowles Johnson, O.D.,Ph.D.
• Phone: 812-855-8991
• Email: kbowlesj[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis, Chronic
• Macular Degeneration
• Pigmentary Retinopathy
• Retinitis Pigmentosa
• Toxic Maculopathy

Intervention

Device:
• Adaptive optics imaging
adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

Locations

Country	Name	City	State
United States	Indiana University School of Optometry	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of this study is to develop new biomarkers of retinal atrophy progression due to pentosan polysulfate sodium toxicity.		2 years