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


The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.

Full Title of Study: “The Effect of L-Dopa on the Progression of Retinitis Pigmentosa”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2017

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.


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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beirut Eye Specialist Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elias F. Jarade, MD, Principal Investigator, Beirut Eye Specialist Hospital
  • Overall Contact(s)
    • Elias F. Jarade, MD, +9613549297,


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.

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