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

NCT01176435 | Completed Phase 2 Results

• 1 other identifier: 0912M75653
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Albinism

Keywords

Levodopa; Albinism; Vision

Outcome Measures

Primary Outcomes (1)

• Improved Vision

  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

Study Arms (3)

0.76 mg/kg L-DOPA

ACTIVE COMPARATOR

Solution taken orally three times a day.

Drug: Levodopa

0.51 mg/kg L-DOPA

ACTIVE COMPARATOR

Solution taken orally three times a day.

Drug: Levodopa

Placebo

PLACEBO COMPARATOR

Solution taken orally three times a day.

Drug: Placebo

Interventions

Levodopa DRUG

Solution taken orally three times a day.

0.76 mg/kg L-DOPA

Placebo DRUG

Solution taken orally three times a day.

Placebo

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 3 to 60 years with albinism

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Eye Clinic

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Albinism

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Results Point of Contact

• Title: C. Gail Summers, MD
• Organization: University of Minnesota

summe001@umn.edu

612-625-6469

Study Officials

• Gail Summers, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 2, 2018
• Results First Posted: May 2, 2018

Record last verified: 2018-04

Locations

US (1)