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

B

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)

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

Trial contacts and locations

0

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Central trial contact

Beirut Eye Specialist Hospital; Elias F. Jarade, MD

Data sourced from clinicaltrials.gov

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