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Natural History Study for Retinitis Pigmentosa (PHENOROD2 Trial)

N/A
Waitlist Available
Led By Saddek Mohand-Saïd, MD, PhD
Research Sponsored by SparingVision
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
RP with mutations affecting the RHO, PDE6A and PDE6B genes
Be older than 18 years old
Must not have
Patients with any other gene mutation known to be involved in RP
Patients with other ocular disorder likely to impact the retinal function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at the effects of different mutations that cause Retinitis Pigmentosa, a degenerative disease of the retina.

Who is the study for?
This study is for individuals with Retinitis Pigmentosa, a degenerative eye condition, specifically caused by mutations in the RHO, PDE6A or PDE6B genes. Participants must have a certain level of visual acuity and field diameter, understand the local language well enough to follow instructions, and be part of a health system if they're in France. Pregnant women or those with other retinal issues are excluded.
What is being tested?
The trial involves regular eye exams and mobility tests to track how Retinitis Pigmentosa progresses over time when it's caused by specific genetic mutations. It's an observational study meaning there's no treatment being tested; instead, researchers are studying the natural course of the disease.
What are the potential side effects?
Since this is an observational study without any medical treatments or drugs being administered, there are no direct side effects from interventions. However, participants may experience discomfort from frequent ophthalmic examinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My retinitis pigmentosa is due to mutations in RHO, PDE6A, or PDE6B genes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a gene mutation linked to retinitis pigmentosa.
Select...
I have an eye condition that could affect my retina's function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fundus Autofluorescence (FAF)
Spectral Domain Optical Coherence tomography (SD-OCT)
Secondary study objectives
Color vision
Dark adaptometry (DA)
Full-field stimulus threshold (FST)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Study Group 2Experimental Treatment2 Interventions
Four years follow-up of patients with ophthalmic examination and mobility testing.
Group II: Study Group 1Experimental Treatment1 Intervention
Four years follow up of patients with ophthalmic examination.

Find a Location

Who is running the clinical trial?

SparingVisionLead Sponsor
2 Previous Clinical Trials
146 Total Patients Enrolled
2 Trials studying Retinitis Pigmentosa
146 Patients Enrolled for Retinitis Pigmentosa
Saddek Mohand-Saïd, MD, PhDPrincipal InvestigatorCHNO XV-XX Paris - CIC 1423
Isabelle Audo, MD, PhDPrincipal InvestigatorCHNO XV-XX Paris - CIC 1423

Media Library

Study Group 1 Clinical Trial Eligibility Overview. Trial Name: NCT04285398 — N/A
Retinitis Pigmentosa Research Study Groups: Study Group 1, Study Group 2
Retinitis Pigmentosa Clinical Trial 2023: Study Group 1 Highlights & Side Effects. Trial Name: NCT04285398 — N/A
Study Group 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04285398 — N/A
~19 spots leftby Jun 2026
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