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Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa

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ClinicalTrials.gov Identifier: NCT02837640
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Beirut Eye Specialist Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Drug: levodopa-carbidopa Phase 2

Detailed Description:
Retinitis pigmentosa is a group of progressive hereditary diseases that diffusely affects the functioning of photoreceptors and the pigment epithelium. It may be speculated that a protective effect on the pigment epithelium, as it is supposed for L-Dopa, can slow the progression of the disease or even lead to an, at least transient, improvement of visual functions. To evaluate the effect of L-Dopa on retinitis pigmentosa progression, visual acuity, electroretinogram and visual field will be preformed regularly.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of L-Dopa on the Progression of Retinitis Pigmentosa
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment

This is a single armed study. All patients included will receive treatment. Control will happen with data from the same patients before they received treatment.

patients will receive sinemet 200/50 1/2 tablet (levodopa-carbidopa 100/25) b.i.d for two days and then will be increased to t.i.d. for 6 months.

 Drug: levodopa-carbidopa
sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months
Other Name: Sinemet 200/50


Outcome Measures
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Primary Outcome Measures :
  1. Change in Electroretinogram [ Time Frame: Baseline, 1 year, 2 years, 5 years ]
    the electric response to light stimuli of the retina, in millivolt, will be measured. The electroretinogram shows a-waves (elicit information about the function of the photoreceptors) and b-waves (elicit information about other neurosensory structure of the retina)


Secondary Outcome Measures :
  1. Change in Visual Acuity [ Time Frame: Baseline, 6 months, 1 year, 2 years, 5 years ]
    Visual acuity will be measured using Snellen chart

  2. Change in Visual Field [ Time Frame: Baseline, 1 year, 2 years, 5 years ]
    Using 24-2 Humphrey Visual Field Analyzer, the progress in visual field defect will be measured, comparing mean deviation (dB) and pattern standard deviation (dB)


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All confirmed cases of retinitis pigmentosa
  • VA of 20/400 or better

Exclusion Criteria:

  • Advanced stages of retinitis pigmentosa with poor best corrected visual acuity (less than 20/400)
  • co-existing eye morbidities interfering with retinitis pigmentosa (glaucoma, retinal detachment...)
  • Flat electroretinogram
  • Intolerance or counterindication to drug
  • Unability for long-term follow-up
Contacts and Locations
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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): NCT02837640


Contacts
Contact: Elias F. Jarade, MD +9613549297 ejarade@yahoo.com
Contact: Beirut Eye Specialist Hospital +961 1 423111 ext 0 info@besh.com.lb

Locations
Lebanon
Beirut Eye Specialist Hospital Recruiting
Beirut, Lebanon, 116-5311
Contact: George Cherfan, MD, Prof    +961 1 423111 ext 160    georgecherfan@gmail.com   
Sponsors and Collaborators
Beirut Eye Specialist Hospital
Investigators
Principal Investigator: Elias F. Jarade, MD Beirut Eye Specialist Hospital
More Information
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Publications:

Responsible Party: Beirut Eye Specialist Hospital
ClinicalTrials.gov Identifier: NCT02837640     History of Changes
Other Study ID Numbers: RP DOPA
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant date will not be shared at the moment being, since it is not of value unless it is thoroughly analysed.

Keywords provided by Beirut Eye Specialist Hospital:
Retinitis Pigmentosa
Levodopa

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
 Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists