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

Primary Purpose

Retinitis Pigmentosa

Status
Unknown status
Phase
Phase 2
Locations
Lebanon
Study Type
Interventional
Intervention
levodopa-carbidopa
Sponsored by
Beirut Eye Specialist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis Pigmentosa, Levodopa

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beirut Eye Specialist HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in Visual Acuity
Visual acuity will be measured using Snellen chart
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)

Full Information

First Posted
June 22, 2016
Last Updated
July 15, 2016
Sponsor
Beirut Eye Specialist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02837640
Brief Title
Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa
Official Title
The Effect of L-Dopa on the Progression of Retinitis Pigmentosa
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beirut Eye Specialist Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
Retinitis Pigmentosa, Levodopa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
levodopa-carbidopa
Other Intervention Name(s)
Sinemet 200/50
Intervention Description
sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months
Primary Outcome Measure Information:
Title
Change in Electroretinogram
Description
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)
Time Frame
Baseline, 1 year, 2 years, 5 years
Secondary Outcome Measure Information:
Title
Change in Visual Acuity
Description
Visual acuity will be measured using Snellen chart
Time Frame
Baseline, 6 months, 1 year, 2 years, 5 years
Title
Change in Visual Field
Description
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)
Time Frame
Baseline, 1 year, 2 years, 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elias F. Jarade, MD
Phone
+9613549297
Email
ejarade@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Beirut Eye Specialist Hospital
Phone
+961 1 423111
Ext
0
Email
info@besh.com.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elias F. Jarade, MD
Organizational Affiliation
Beirut Eye Specialist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beirut Eye Specialist Hospital
City
Beirut
ZIP/Postal Code
116-5311
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Cherfan, MD, Prof
Phone
+961 1 423111
Ext
160
Email
georgecherfan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant date will not be shared at the moment being, since it is not of value unless it is thoroughly analysed.
Citations:
PubMed Identifier
26524704
Citation
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.
Results Reference
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Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa

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