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

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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

Tracking Information
First Submitted Date  ICMJE August 4, 2010
First Posted Date  ICMJE August 6, 2010
Results First Submitted Date  ICMJE June 22, 2016
Results First Posted Date  ICMJE May 2, 2018
Last Update Posted Date May 2, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2010)
Improved Vision [ Time Frame: Week 55 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of L-DOPA as a Treatment to Improve Vision in Albinism
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Albinism
Intervention  ICMJE
  • Drug: Levodopa
    Solution taken orally three times a day.
  • Drug: Placebo
    Solution taken orally three times a day.
Study Arms  ICMJE
  • Active Comparator: 0.76 mg/kg L-DOPA
    Solution taken orally three times a day.
    Intervention: Drug: Levodopa
  • Active Comparator: 0.51 mg/kg L-DOPA
    Solution taken orally three times a day.
    Intervention: Drug: Levodopa
  • Placebo Comparator: Placebo
    Solution taken orally three times a day.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
45
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2010)
50
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01176435
Other Study ID Numbers  ICMJE 0912M75653
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gail Summers, M.D. University of Minnesota
PRS Account University of Minnesota
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP