Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa
The Effect of L-Dopa on the Progression of Retinitis Pigmentosa
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 19, 2016
July 1, 2016
1 year
June 22, 2016
July 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Electroretinogram
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)
Baseline, 1 year, 2 years, 5 years
Secondary Outcomes (2)
Change in Visual Acuity
Baseline, 6 months, 1 year, 2 years, 5 years
Change in Visual Field
Baseline, 1 year, 2 years, 5 years
Study Arms (1)
Treatment
EXPERIMENTALThis 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.
Interventions
sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months
Eligibility Criteria
You may qualify if:
- All confirmed cases of retinitis pigmentosa
- VA of 20/400 or better
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beirut Eye Specialist Hospital
Beirut, 116-5311, Lebanon
Related Publications (1)
Brilliant MH, Vaziri K, Connor TB Jr, Schwartz SG, Carroll JJ, McCarty CA, Schrodi SJ, Hebbring SJ, Kishor KS, Flynn HW Jr, Moshfeghi AA, Moshfeghi DM, Fini ME, McKay BS. Mining Retrospective Data for Virtual Prospective Drug Repurposing: L-DOPA and Age-related Macular Degeneration. Am J Med. 2016 Mar;129(3):292-8. doi: 10.1016/j.amjmed.2015.10.015. Epub 2015 Oct 30.
PMID: 26524704BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elias F. Jarade, MD
Beirut Eye Specialist Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2016
First Posted
July 19, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2021
Last Updated
July 19, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant date will not be shared at the moment being, since it is not of value unless it is thoroughly analysed.