Phase 2
Completed N=45
Trial of L-DOPA as a Treatment to Improve Vision in Albinism
Albinism
Source: ClinicalTrials.gov NCT01176435 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Improved Vision — 0.67; 0.55; 0.53 logMAR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improved Vision |
0.67; 0.55; 0.53 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01176435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.