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Trial of L-DOPA as a Treatment to Improve Vision in Albinism

Primary Purpose

Albinism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levodopa
Levodopa
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Albinism focused on measuring Levodopa, Albinism, Vision

Eligibility Criteria

3 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 3 to 60 years with albinism

Exclusion Criteria:

  • Glaucoma or at increased risk of glaucoma
  • History of dystonia
  • History of melanoma
  • Planning to undergo eye muscle surgery during study time frame
  • Undergoing vision therapy
  • Taking iron supplements or vitamins with iron
  • Taking medication for ADHD
  • Known liver or gastrointestinal disease
  • Previous treatment with levodopa
  • Psychological problems
  • Ocular abnormalities other than those associated with albinism
  • Pregnant, nursing or planning to become pregnant during study
  • Known allergy to levodopa/carbidopa

Sites / Locations

  • University of Minnesota Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

0.76 mg/kg L-DOPA

0.51 mg/kg L-DOPA

Placebo

Arm Description

Solution taken orally three times a day.

Solution taken orally three times a day.

Solution taken orally three times a day.

Outcomes

Primary Outcome Measures

Improved Vision
Binocular best-corrected visual acuity-The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart) or a card held 20 feet (6 meters) away. Special charts are used when testing at distances shorter than 20 feet (6 meters). Ranges are 20/10 vision to 20/200 vision. 20/10 being the best and 20/200 being the worse.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2010
Last Updated
April 30, 2018
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01176435
Brief Title
Trial of L-DOPA as a Treatment to Improve Vision in Albinism
Official Title
Clinical Trial to Evaluate Levodopa as Treatment to Improve Vision in Individuals With Albinism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project will evaluate the effect of two doses of levodopa (L-DOPA) in a randomized, placebo-controlled, double-masked clinical trial to see if vision can be improved in individuals with albinism. The hypothesis is that providing L-DOPA to the retinas of these individuals may increase melanin pigment production. Increased melanin has previously been shown to be associated with improved vision.
Detailed Description
A group of 45 individuals with the clinical findings of oculocutaneous albinism (OCA) will be randomly assigned to one of 3 treatment groups: treatment with 0.76 mg/kg/d with 25% carbidopa, 0.51 mg/kg/d levodopa with 25% carbidopa [divided into 3 doses/d), or placebo. Subjects will be between ages 3 and 60 years. Blood will be drawn to determine the mutation(s) in the genes that causes OCA. Primary outcome will be binocular best-corrected visual acuity measured with the EVA. Enrollment and 20 week examination will be complete eye exam with fundus photos. At weeks 5, 10, and 15, exams will include just vital signs and BCVA. At all visits, a review of potential side effects will be conducted. Between visits, subjects will be contacted to determine if any side effects have occurred. The study will remain double masked until the last study examination on the last subject has been performed. At that time, the data will be statistically analyzed and subjects will be informed re: treatment assignment, mutations found, and the study results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albinism
Keywords
Levodopa, Albinism, Vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.76 mg/kg L-DOPA
Arm Type
Active Comparator
Arm Description
Solution taken orally three times a day.
Arm Title
0.51 mg/kg L-DOPA
Arm Type
Active Comparator
Arm Description
Solution taken orally three times a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Solution taken orally three times a day.
Intervention Type
Drug
Intervention Name(s)
Levodopa
Intervention Description
Solution taken orally three times a day.
Intervention Type
Drug
Intervention Name(s)
Levodopa
Intervention Description
Solution taken orally three times a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution taken orally three times a day.
Primary Outcome Measure Information:
Title
Improved Vision
Description
Binocular best-corrected visual acuity-The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart) or a card held 20 feet (6 meters) away. Special charts are used when testing at distances shorter than 20 feet (6 meters). Ranges are 20/10 vision to 20/200 vision. 20/10 being the best and 20/200 being the worse.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 3 to 60 years with albinism Exclusion Criteria: Glaucoma or at increased risk of glaucoma History of dystonia History of melanoma Planning to undergo eye muscle surgery during study time frame Undergoing vision therapy Taking iron supplements or vitamins with iron Taking medication for ADHD Known liver or gastrointestinal disease Previous treatment with levodopa Psychological problems Ocular abnormalities other than those associated with albinism Pregnant, nursing or planning to become pregnant during study Known allergy to levodopa/carbidopa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Summers, M.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Eye Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Trial of L-DOPA as a Treatment to Improve Vision in Albinism

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