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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837640
Enrollment
50
Registered
2016-07-19
Start date
2016-06-30
Completion date
2021-06-30
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Keywords

Retinitis Pigmentosa, Levodopa

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.

Interventions

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

Sponsors

Beirut Eye Specialist Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in ElectroretinogramBaseline, 1 year, 2 years, 5 yearsthe 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

MeasureTime frameDescription
Change in Visual AcuityBaseline, 6 months, 1 year, 2 years, 5 yearsVisual acuity will be measured using Snellen chart
Change in Visual FieldBaseline, 1 year, 2 years, 5 yearsUsing 24-2 Humphrey Visual Field Analyzer, the progress in visual field defect will be measured, comparing mean deviation (dB) and pattern standard deviation (dB)

Countries

Lebanon

Contacts

Primary ContactElias F. Jarade, MD
ejarade@yahoo.com+9613549297
Backup ContactBeirut Eye Specialist Hospital
info@besh.com.lb+961 1 423111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026