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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03901391
Other study ID # RU-RP-03-2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 26, 2019
Est. completion date October 20, 2020

Study information

Verified date May 2022
Source Sensor Technology for Deafblind
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is aimed to characterize Russian population of Retinitis Pigmentosa


Description:

This study is aimed to characterize Russian population of Retinitis Pigmentosa. Tasks: Stage 1. Formation of the primary cohort of patients. Patients pre-recruiting will be performed based on Deaf-Blind Support Foundation "Con-nection" patient database analysis and from references. Patients with clinically confirmed Retinitis pigmentosa will be evaluated according to available data of the clinical examination. Stage 2. Genetic study of patients. All enrolled patients will undergo single 4 ml peripheral venous blood sampling. DNA will be extracted from leucocytes. DNA samples will be analyzed and placed for long-term storage in liquid nitrogen. Stage 3. Clinical examination of patients. Each patient will undergo the following diagnostic procedures according to the unified protocol: - Visometry (with correction and without correction) - Ophthalmoscopy - Perimetry - Optical coherence tomography - Electroretinography - Visually evoked potentials - Refractometry - Pneumotonometry - Biomicroscopy - Any additional examinations and consultations if necessary Medical record will be developed and maintained for each patient consisting results of extended clinical examination. Statistical and bioinformatic analysis of detected genetic mutations in the study cohort will be performed.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date October 20, 2020
Est. primary completion date October 19, 2020
Accepts healthy volunteers
Gender All
Age group 6 Years to 65 Years
Eligibility Inclusion Criteria: - Patient fulfill the clinical characteristics for Retinitis Pigmentosa (AD, AR, X-linked, sporadic) as defined by the Retinitis pigmentosa consortium - Results of perimetry for each eye show narrowing for 15 degrees or more. - Patient is familiar with Participant information sheet - Patient signed informed consent form Non-inclusion Criteria: - Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion - Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.) - Medical history of traumatic injury of eyes, barotrauma, concussion, craniocerebral trauma, cerebrovascular accident - Congenital multiple development orbit and eye malformations Exclusion Criteria: - Patient's refusal from the further participation in the trial - Decompensated diabetes mellitus - Severe coronary artery disease - Chronic infectious disease - Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Whole Exome Sequencing
Whole Exome Sequencing

Locations

Country Name City State
Russian Federation Central Clinical Hospital under President Affairs Moscow
Russian Federation Federal State Budgetary Institution "Moscow Helmholtz Research Institute of Eye Diseases" of the Ministry of Health Moscow

Sponsors (7)

Lead Sponsor Collaborator
Sensor Technology for Deafblind Center for Genetics and Reproductive Medicine Genetico, Central Clinical Hospital under President Affairs, Deaf-Blind Support Foundation Con-nection, Federal State Budgetary Institution Moscow Helmholtz Eye Research Institute, Federal State Budgetary Institution Research Center for Medical Genetics, Oftalmic LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in visual acuity Measured by visual acuity test Up to 4 weeks
Primary Changes in structures of fundus of the eye-1 Measured by ophthalmoscopy Up to 4 weeks
Primary Changes in structures of fundus of the eye-2 Measured by ophthalmoscopy Up to 4 weeks
Primary Changes in visual field Measured by perimetry Up to 4 weeks
Primary Changes in brain visual cortex neural pathways Measured by visually evoked potentials Up to 4 weeks
Primary Changes in electroretinogram Measured by electroretinography Up to 4 weeks
Primary Changes in optical refraction Measured by refractometry Up to 4 weeks
Primary Changes in intraocular pressure Measured by pneumotonometry Up to 4 weeks
Primary Changes in the lens, cornea, anterior segment of the eye Measured by biomicroscopy Up to 4 weeks
Primary Changes in central retinal profile Measured by optical coherent tomography Up to 4 weeks
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