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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

levodopa-carbidopa

Intervention Type DRUG

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

Interventions

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levodopa-carbidopa

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

Intervention Type DRUG

Other Intervention Names

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Sinemet 200/50

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No