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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02837640 |
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Date of registration:
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22/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa
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Scientific title:
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The Effect of L-Dopa on the Progression of Retinitis Pigmentosa |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02837640 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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George Cherfan, MD, Prof |
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Address:
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Telephone:
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+961 1 423111 |
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Email:
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georgecherfan@gmail.com |
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Affiliation:
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Name:
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Elias F. Jarade, MD |
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Address:
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Telephone:
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+9613549297 |
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Email:
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ejarade@yahoo.com |
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Affiliation:
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Name:
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Elias F. Jarade, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beirut Eye Specialist Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
10 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Retinitis Pigmentosa
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Intervention(s)
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Drug: levodopa-carbidopa
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Primary Outcome(s)
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Change in Electroretinogram
[Time Frame: Baseline, 1 year, 2 years, 5 years]
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Secondary Outcome(s)
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Change in Visual Acuity
[Time Frame: Baseline, 6 months, 1 year, 2 years, 5 years]
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Change in Visual Field
[Time Frame: Baseline, 1 year, 2 years, 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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