Trial | NCT02837640  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.
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 Started
Jun 30
2016
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Jun 30
2021
Anticipated
Last Update
Jul 19
2016
Estimate

Drug levodopa-carbidopa

sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months

  • Other names: Sinemet 200/50

Treatment Experimental

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.

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
No Results Posted