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Vision Response to Dopamine Replacement

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ClinicalTrials.gov Identifier: NCT01663935
Recruitment Status : Terminated (Lack of funding)
First Posted : August 14, 2012
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE August 9, 2012
First Posted Date  ICMJE August 14, 2012
Results First Submitted Date  ICMJE April 9, 2019
Results First Posted Date  ICMJE June 11, 2019
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE October 17, 2012
Actual Primary Completion Date April 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
Visual Acuity Change [ Time Frame: 3 months ]
Change in visual acuity from baseline to 3 months as measured in logMAR by Snellen or Sweep visual evoked potential (SVEP). logMar lower values equals better visual outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2012)
Visual Acuity Improvement [ Time Frame: 3 months ]
Change in visual acuity as measured in logMAR by Snellen or Sweep visual evoked potential (SVEP)
Change History Complete list of historical versions of study NCT01663935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2012)
Retinal Function [ Time Frame: 3 months ]
Electroretinography -- electro physiologic testing of retinal function
Current Other Pre-specified Outcome Measures
 (submitted: May 17, 2019)
Contrast Sensitivity [ Time Frame: 3 months ]
Ancillary testing of visual/retinal function with contrast sensitivity testing. Contrast sensitivity testing measures how well the eyes can distinguish between finer and finer light increments compared to dark. This test is a chart with different capital letters organized in horizontal lines. The contrast decreases with each line. The person will move down the chart to determine the least level of contrast they can see.
Original Other Pre-specified Outcome Measures
 (submitted: August 13, 2012)
Color and Contrast sensitivity [ Time Frame: 3 months ]
Ancillary testing of visual/retinal function
 
Descriptive Information
Brief Title  ICMJE Vision Response to Dopamine Replacement
Official Title  ICMJE Interventional Study of Levodopa Replacement on Retinal Function in Oculocutaneous Albinism
Brief Summary The purpose of the study is to evaluate and document physiologic and functional changes in visual performance and retinal function of patients diagnosed with albinism (a dopamine deficiency state) following a trial of oral Levodopa/carbidopa treatment.
Detailed Description In this study the investigators propose that the retina itself in albinism is deficient in dopamine, and vision improvement will occur as a result of improved retinal function in response to the deficient neurotransmitter dopamine. This study has a pretest-posttest design in order to determine if improvement in vision is in response to replacement of deficiency (dopamine). The electroretinography (ERG) testing and optical coherence tomography (OCT) will be critical determinants to confirm vision improvement as a result of improved retinal function, but are not primary outcome data. Main outcome measures will be collected at pre-treatment, 1 month, 3 months, and 4 months. Change in visual acuity as measured in logMAR by Snellen or sweep visual evoked potential (SVEP) after 3 months of treatment is the primary outcome. Patients include OCA1a patients, OCA1b, OCA2, and unclassified Oculocutaneous albinism (OCA). OCA1a patients clinically are known to have the worst vision, and physiologically have the lowest (or absent) levels of tyrosinase function (Dopamine Production). All patients will be treated with Levodopa/carbidopa 4mg/kg/day in three divided doses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Albinism
  • Oculocutaneous Albinism
Intervention  ICMJE Drug: Levodopa/carbidopa
This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
Other Names:
  • Sinemet
  • Atamet
  • Parcopa
Study Arms  ICMJE Levodopa/carbidopa 4mg/kg/day
Treatment drug taken orally three times daily
Intervention: Drug: Levodopa/carbidopa
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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 17, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2012)
50
Actual Study Completion Date  ICMJE April 12, 2018
Actual Primary Completion Date April 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical diagnosis of oculocutaneous albinism
  • age over 3 and weight over 25 lbs.

Exclusion Criteria:

  • ocular only albinism
  • ocular pathology other than albinism
  • neurologic disease, history of myocardial infarction, history of clinical depression, pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older 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 NCT01663935
Other Study ID Numbers  ICMJE 2016-1576
2012-0023 ( Other Identifier: Study team )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael C Struck, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date May 2019

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