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Prospective Natural History Study of Retinitis Pigmentosa (PHENOROD2)

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ClinicalTrials.gov Identifier: NCT04285398
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
SparingVision

Brief 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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Other: Ophthalmic examination Other: Mobility Test Not Applicable

Detailed Description:
This is an open, longitudinal, ambispective, single center study to describe one-year disease progression in patients with retinitis pigmentosa due to mutation in genes with selective expression in rods: rhodopsin (RHO), phosphodiesterase 6A (PDE6A) or phosphodiesterase 6B (PDE6B).RHO,PDE6A or PDE6B mutation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: One-Year Natural History Study of Retinitis Pigmentosa Due to RHO, PDE6A or PDE6B Mutations
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : October 1, 2021


Arm Intervention/treatment
Study Group 1
One year follow up of patients with ophthalmic examination.
Other: Ophthalmic examination
Visual Acuity, Visual Field, FST, Dark adaptometry, Color Vision testing, OCT and FAF.

Study Group 2
One year follow-up of patients with ophthalmic examination and mobility testing.
Other: Ophthalmic examination
Visual Acuity, Visual Field, FST, Dark adaptometry, Color Vision testing, OCT and FAF.

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




Primary Outcome Measures :
  1. Spectral Domain Optical Coherence tomography (SD-OCT) [ Time Frame: 1 year ]
    Progression of disease over time as measured by SD-OCT (EZ length, ELM length, ONL thickness, macular volume).

  2. Fundus Autofluorescence (FAF) [ Time Frame: 1 year ]
    Progression of disease as measured by FAF (Hyperautofluorescent ring)


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 1 year ]
    Progression of disease over time as measured by best corrected visual acuity (BCVA) (ETDRS, Snellen) and refraction

  2. Visual field [ Time Frame: 1 year ]
    Progression of disease over time as measured by kinetic and static visual fields

  3. Full-field stimulus threshold (FST) [ Time Frame: 1 year ]
    Progression of disease over time as measured by FST

  4. Color vision [ Time Frame: 1 year ]
    15 Hue Desaturated Lanthony

  5. Dark adaptometry (DA) [ Time Frame: 1 year ]
    Progression of disease over time as measured by DA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RP with mutations affecting the RHO, PDE6A and PDE6B genes
  • Visual acuity ≥ 20/200 for at least one eye
  • Binocular Visual field diameter ≥ 5° as measured on the Goldmann III-4e isopter

Exclusion Criteria:

  • Patients with any other gene mutation known to be involved in RP
  • Patients with other ocular disorder likely to impact the visual function
  • Pregnant or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285398


Contacts
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Contact: Florence Allouche +33143462060 info@sparingvision.com

Locations
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France
CHNO XV-XX Paris - CIC 1423 Recruiting
Paris, France, 75012
Contact: Saddek Mohand-Saïd, M.D, Ph.D       mohand@quinze-vingts.fr   
Principal Investigator: Saddek Mohand-Saïd, MD, PhD         
Sub-Investigator: José-Alain Sahel, MD, PhD         
Sub-Investigator: Isabelle Audo, MD, PhD         
Sponsors and Collaborators
SparingVision
Investigators
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Principal Investigator: Saddek Mohand-Saïd, MD, PhD CHNO XV-XX Paris - CIC 1423
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Responsible Party: SparingVision
ClinicalTrials.gov Identifier: NCT04285398    
Other Study ID Numbers: PHENOROD2
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SparingVision:
RHO
PDE6A
PDE6B
Pathogenic Mutation
Prospective
Natural History
Retinal Disease
Eye Disease
Blindness
Inherited Eye Disease
Vision Disorder
Inherited Retinal Disorder
Rod-Cone Dystrophy
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn