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

Albinism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176435
• Other study ID #: 0912M75653
• Status: Completed
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Albinism

Intervention

Drug:
• Levodopa
Solution taken orally three times a day.
• Levodopa
Solution taken orally three times a day.
• Placebo
Solution taken orally three times a day.

Locations

Country	Name	City	State
United States	University of Minnesota Eye Clinic	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 weeks