NCT01190813

Levodopa for the Treatment of Residual Amblyopia

A Randomized Trial of Levodopa as Treatment for Residual Amblyopia (ATS 17)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to \<13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.

Detailed description

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study where children 7 to 12 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity. Many clinicians have recognized that conventional therapies with patching and atropine have not been universally successful and have sought alternatives. PEDIG has discussed for several years the problem of residual amblyopia and how the remaining visual acuity deficit could be reduced. A number of research groups have evaluated the short term use of oral levodopa-carbidopa as an adjunct to patching therapy for older children.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DRUG	Levodopa/Carbidopa	Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
DRUG	Placebo	Oral placebo tid
OTHER	Patching	Two hours of daily patching

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-01-01
• Completion: 2014-04-01
• First posted: 2010-08-30
• Last updated: 2016-06-02
• Results posted: 2015-02-13

Locations

1 site across 1 country: United States