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

July 15, 2016 updated by: Beirut Eye Specialist Hospital

The Effect of L-Dopa on the Progression of Retinitis Pigmentosa

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon, 116-5311
        • Recruiting
        • Beirut Eye Specialist Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Sinemet 200/50

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 1 year, 2 years, 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Acuity
Time Frame: Baseline, 6 months, 1 year, 2 years, 5 years
Visual acuity will be measured using Snellen chart
Baseline, 6 months, 1 year, 2 years, 5 years
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)
Baseline, 1 year, 2 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beirut Eye Specialist Hospital

Investigators

  • Principal Investigator: Elias F. Jarade, MD, Beirut Eye Specialist Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP DOPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant date will not be shared at the moment being, since it is not of value unless it is thoroughly analysed.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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