Trial of L-DOPA as a Treatment to Improve Vision in Albinism
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 3 - 60 |
| Updated: | 5/4/2018 |
| Start Date: | September 2010 |
| End Date: | December 2014 |
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.
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.
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.
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.
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
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