Phase 2 N=45 Randomized Double-blind Treatment

Trial of L-DOPA as a Treatment to Improve Vision in Albinism

Albinism

Bottom Line

View on ClinicalTrials.gov: NCT01176435 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Improved Vision — 0.67; 0.55; 0.53 logMAR

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Levodopa (Drug); Placebo (Drug)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Improved Vision	0.67; 0.55; 0.53	—

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.

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

View full record on ClinicalTrials.gov →

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.