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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Trial to Evaluate Levodopa as Treatment to Improve Vision in Individuals With Albinism

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 Summary: 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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Improved vision [ Time Frame: Week 55 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: August 4, 2010
Date Started: September 2010
Date Completion:
Last Updated: December 9, 2014
Last Verified: December 2014