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

Beirut Eye Specialist Hospital

Status and phase: Unknown; Phase 2

Conditions: Retinitis Pigmentosa

Treatments: Drug: levodopa-carbidopa

Study type: Interventional

Funder types: Other

Identifiers

NCT02837640

RP DOPA

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Drug: levodopa-carbidopa