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

Phase 2

• Conditions: Retinitis Pigmentosa
• Interventions: Drug: levodopa-carbidopa

• Registration Number: NCT02837640
• Lead Sponsor: Beirut Eye Specialist Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-15
• Last Update Submitted: 2016-07-15
• Study First Posted: 2016-07-19
• Last Update Posted: 2016-07-19
• Primary Completion: 2017-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	levodopa-carbidopa	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.

Primary Outcome Measures

Name	Time	Method
Change in Electroretinogram	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 Outcome Measures

Name	Time	Method
Change in Visual Field	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)
Change in Visual Acuity	Baseline, 6 months, 1 year, 2 years, 5 years	Visual acuity will be measured using Snellen chart

Trial Locations

Locations (1)

Beirut Eye Specialist Hospital; 🇱🇧 Beirut, Lebanon