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Clinical Trials in France / NCT04285398
Active, not recruiting Not applicable

Prospective Natural History Study of Retinitis Pigmentosa

NCT04285398 · tracked via the Priya Life Science France tracker
Sponsor
SparingVision
Phase
Not applicable
Started
2020-02-12
Last updated
2025-05-22

Condition(s) studied

Retinitis Pigmentosa

Investigational drug(s) / intervention(s)

Ophthalmic examinationsMobility Test

Ophthalmic examinations: Slit-lamp examination, IntraOcular Pressure, Visual Acuity, Visual Field, Full-field Stimulus Threshold, Dark adaptometry, Color Vision testing, Optical Coherence Tomography, Fundus AutoFluorescence and Adaptive Optics imaging.

Mobility Test: Functional test to evaluate mobility and postural condition of patients

Study summary

This is natural history study of rods and cones degenerations in patients with Retinitis Pigmentosa (RP) caused by pathogenic mutations in RHO, PDE6a or PDE6b gene mutations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * RP with mutations affecting the RHO, PDE6A and PDE6B genes * Visual acuity ≥ 20/200 for at least one eye at inclusion visit * Binocular Visual field diameter ≥ 5° as measured on the Goldmann III-4e isopter at inclusion visit * Patients having signed the informed consent form * Sufficient knowledge of the local language to ensure understanding of the tasks to be performed and the instructions received * Patient affiliated to a Health Security System if they are included in a clinical site based in France (per law) Exclusion Criteria: * Patients with any other gene mutation known to be involved in RP * Patients with other ocular disorder likely to impact the retinal function * Pregnant or breastfeeding women

Primary outcome measure(s)

  • Spectral Domain Optical Coherence tomography (SD-OCT) — 1 year
    Progression of disease over time as measured by SD-OCT (EZ length, ELM length, ONL thickness, macular volume).
  • Fundus Autofluorescence (FAF) — 1 year
    Progression of disease as measured by FAF (Hyperautofluorescent ring)

Trial sites (2)

FacilityCityRegionStatus
UPMC Eye Center Pittsburgh Pennsylvania
CHNO XV-XX Paris - CIC 1423 Paris France

More SparingVision trials in France

Natural History Study of Advanced RCD Recruiting
Promising ROd-cone DYstrophy Gene therapY Active, not recruiting
Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Gene Therapy (SPVN20) in Subjects With Rod-Cone Dystrophy Recruiting

Other trials for the same condition

Study of BEST1 Vitelliform Macular Dystrophy Recruiting
High Resolution, High-speed Multimodal Ophthalmic Imaging Recruiting
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants Recruiting
Promising ROd-cone DYstrophy Gene therapY Active, not recruiting
Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04285398 on ClinicalTrials.gov ↗ ← All trials in France