Vision Response to Dopamine Replacement
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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: NCT01663935 |
Recruitment Status :
Terminated
(Lack of funding)
First Posted : August 14, 2012
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
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Condition or disease | Intervention/treatment | Phase |
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Albinism Oculocutaneous Albinism | Drug: Levodopa/carbidopa | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Interventional Study of Levodopa Replacement on Retinal Function in Oculocutaneous Albinism |
Actual Study Start Date : | October 17, 2012 |
Actual Primary Completion Date : | April 12, 2018 |
Actual Study Completion Date : | April 12, 2018 |

Arm | Intervention/treatment |
---|---|
Levodopa/carbidopa 4mg/kg/day
Treatment drug taken orally three times daily
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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:
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- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01663935
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53705 |
Principal Investigator: | Michael C Struck, MD | University of Wisconsin, Madison |
Documents provided by University of Wisconsin, Madison:
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT01663935 |
Other Study ID Numbers: |
2016-1576 2012-0023 ( Other Identifier: Study team ) |
First Posted: | August 14, 2012 Key Record Dates |
Results First Posted: | June 11, 2019 |
Last Update Posted: | June 11, 2019 |
Last Verified: | May 2019 |
levodopa Albinism dopamine |
oculocutaneous albinism vision retina function |
Albinism Albinism, Oculocutaneous 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 Carbidopa Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors |