Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa
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ClinicalTrials.gov Identifier: NCT02837640 |
Recruitment Status : Unknown
Verified July 2016 by Beirut Eye Specialist Hospital.
Recruitment status was: Recruiting
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Retinitis Pigmentosa | Drug: levodopa-carbidopa | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
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 |

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 |
- 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)
- Change in Visual Acuity [ Time Frame: Baseline, 6 months, 1 year, 2 years, 5 years ]Visual acuity will be measured using Snellen chart
- 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)

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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 |
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

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
Contact: Elias F. Jarade, MD | +9613549297 | ejarade@yahoo.com | |
Contact: Beirut Eye Specialist Hospital | +961 1 423111 ext 0 | info@besh.com.lb |
Lebanon | |
Beirut Eye Specialist Hospital | Recruiting |
Beirut, Lebanon, 116-5311 | |
Contact: George Cherfan, MD, Prof +961 1 423111 ext 160 georgecherfan@gmail.com |
Principal Investigator: | Elias F. Jarade, MD | Beirut Eye Specialist Hospital |
Responsible Party: | Beirut Eye Specialist Hospital |
ClinicalTrials.gov Identifier: | NCT02837640 |
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. |
Retinitis Pigmentosa Levodopa |
Retinitis Retinitis Pigmentosa 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 |