Clinical Trial

Valproate for the Treatment of Residual Amblyopia

Study acronym: VARA
Recruiting Phase 1/2
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Summary
The goal of this clinical trial is to determine the efficacy of valproate as an adjunct therapy to treat amblyopia beyond the critical period in children aged 8-17 years who have amblyopia of ≥3 lines of interocular best-corrected (with glasses) visual acuity difference. The main questions it aims to answer are: * Does valproate enable clinically meaningful and durable visual recovery from amblyopia? * Do valproate-treated patients show a change in amblyopic eye visual acuity (lines)? Participants will undergo daily patching for 2 hours (standard of care) plus the addition of valproate or placebo for a total of 16 weeks.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-31
Trial Details
NCT Number NCT07226141
Lead Sponsor Boston Children's Hospital
Conditions Amblyopia, Amblyopia Unilateral, Amblyopia, Anisometropic, Amblyopia Strabismic
Enrollment 28 participants
Start Date 2026-07-01
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-30