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

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02837640
• Other study ID #: RP DOPA
• Status: Recruiting
• Phase: Phase 2
• First received: June 22, 2016
• Last updated: July 15, 2016
• Start date: June 2016
• Est. completion date: June 2021

Study information

• Verified date: July 2016
• Source: Beirut Eye Specialist Hospital
• Contact: Elias F. Jarade, MD
• Phone: +9613549297
• Email: ejarade[@]yahoo.com
• Is FDA regulated: No
• Health authority: Lebanon: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2021
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Drug:
• levodopa-carbidopa
sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months

Locations

Country	Name	City	State
Lebanon	Beirut Eye Specialist Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Beirut Eye Specialist Hospital

Country where clinical trial is conducted

Lebanon, 

References & Publications (1)

Brilliant MH, Vaziri K, Connor TB Jr, Schwartz SG, Carroll JJ, McCarty CA, Schrodi SJ, Hebbring SJ, Kishor KS, Flynn HW Jr, Moshfeghi AA, Moshfeghi DM, Fini ME, McKay BS. Mining Retrospective Data for Virtual Prospective Drug Repurposing: L-DOPA and Age-related Macular Degeneration. Am J Med. 2016 Mar;129(3):292-8. doi: 10.1016/j.amjmed.2015.10.015. Epub 2015 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Electroretinogram	the 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)	Baseline, 1 year, 2 years, 5 years	No
Secondary	Change in Visual Acuity	Visual acuity will be measured using Snellen chart	Baseline, 6 months, 1 year, 2 years, 5 years	No
Secondary	Change in Visual Field	Using 24-2 Humphrey Visual Field Analyzer, the progress in visual field defect will be measured, comparing mean deviation (dB) and pattern standard deviation (dB)	Baseline, 1 year, 2 years, 5 years	No