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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01176435
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Albinism Drug: Levodopa Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate Levodopa as Treatment to Improve Vision in Individuals With Albinism
Study Start Date : September 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 0.76 mg/kg L-DOPA
Solution taken orally three times a day.
 Drug: Levodopa
Solution taken orally three times a day.
Active Comparator: 0.51 mg/kg L-DOPA
Solution taken orally three times a day.
 Drug: Levodopa
Solution taken orally three times a day.
Placebo Comparator: Placebo
Solution taken orally three times a day.
 Drug: Placebo
Solution taken orally three times a day.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176435


Locations
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United States, Minnesota
University of Minnesota Eye Clinic
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Gail Summers, M.D. University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01176435    
Other Study ID Numbers: 0912M75653
First Posted: August 6, 2010    Key Record Dates
Results First Posted: May 2, 2018
Last Update Posted: May 2, 2018
Last Verified: April 2018
Keywords provided by University of Minnesota:
Levodopa
Albinism
Vision
Additional relevant MeSH terms:
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Albinism
Eye Diseases, Hereditary
Eye Diseases
Genetic Diseases, Inborn
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Skin Diseases, Genetic
Hypopigmentation
Pigmentation Disorders
 Skin Diseases
Metabolic Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs