- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176435
Trial of L-DOPA as a Treatment to Improve Vision in Albinism
April 30, 2018 updated by: University of Minnesota
Clinical Trial to Evaluate Levodopa as Treatment to Improve Vision in Individuals With 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.
Study Overview
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
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Eye Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 58 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 0.76 mg/kg L-DOPA
Solution taken orally three times a day.
|
Solution taken orally three times a day.
|
Active Comparator: 0.51 mg/kg L-DOPA
Solution taken orally three times a day.
|
Solution taken orally three times a day.
|
Placebo Comparator: Placebo
Solution taken orally three times a day.
|
Solution taken orally three times a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gail Summers, M.D., University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 4, 2010
First Submitted That Met QC Criteria
August 4, 2010
First Posted (Estimate)
August 6, 2010
Study Record Updates
Last Update Posted (Actual)
May 2, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Skin Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Eye Diseases, Hereditary
- Metabolism, Inborn Errors
- Amino Acid Metabolism, Inborn Errors
- Pigmentation Disorders
- Hypopigmentation
- Albinism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Levodopa
Other Study ID Numbers
- 0912M75653
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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