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

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

Sponsors

Lead Sponsor: Beirut Eye Specialist Hospital

Source Beirut Eye Specialist Hospital
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.

Overall Status Recruiting
Start Date June 2016
Completion Date June 2021
Primary Completion Date June 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Electroretinogram Baseline, 1 year, 2 years, 5 years
Secondary Outcome
Measure Time Frame
Change in Visual Acuity Baseline, 6 months, 1 year, 2 years, 5 years
Change in Visual Field Baseline, 1 year, 2 years, 5 years
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: levodopa-carbidopa

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

Arm Group Label: Treatment

Other Name: Sinemet 200/50

Eligibility

Criteria:

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

Gender: All

Minimum Age: 10 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Elias F. Jarade, MD Principal Investigator Beirut Eye Specialist Hospital
Overall Contact

Last Name: Elias F. Jarade, MD

Phone: +9613549297

Email: [email protected]

Location
Facility: Status: Contact: Beirut Eye Specialist Hospital George Cherfan, MD, Prof +961 1 423111 160 [email protected]
Location Countries

Lebanon

Verification Date

July 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Treatment

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov