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NCT Number: NCT01176435

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

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.

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Key information

Conditions

Albinism Amino Acid Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Hypopigmentation Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Pigmentation Disorders Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota Eye Clinic

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levodopa

Drug

Solution taken orally three times a day.

Placebo

Drug

Solution taken orally three times a day.

Primary outcomes

  1. Improved Vision

    Time frame: 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2010
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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