Protocol: ATS17 - A Randomized Trial of Levodopa as Treatment for Residual Amblyopia
Status: Closed
Start Date: 09/01/2010
End Date: 10/31/2013
Clinical Trial ID: NCT01190813
Public Dataset:  Download


A Randomized Trial of Levodopa as Treatment for Residual Amblyopia

Protocol

Primary Objective:

  • The primary objective of the study is to compare the efficacy and safety of oral levodopa and patching versus oral placebo and patching at 18 weeks, after 16 weeks of treatment for amblyopia in children 7 to <13 years old followed by a two-week taper of oral medication.

Secondary Objectives:
  • To evaluate maximum improvement in visual acuity with oral levodopa plus patching versus oral placebo plus patching through 26 weeks.

  • To evaluate the frequency of recurrence of amblyopia after 13 weeks of no therapy, among subjects from both randomized treatment groups who have improved from baseline by 10 or more letters in amblyopic eye visual acuity at 26 weeks and are ready to stop amblyopia treatment.

Publications:

  1. Pediatric Eye Disease Investigator Group. A randomized trial of levodopa as treatment for residual amblyopia in older children. Ophthalmology 2015;122:874-81.
 



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