About this trial

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.

Eligibility criteria

Qualifiers

Age 8-17 years

Amblyopia associated with strabismus and/or anisometropia

Heterotropia at distance and/or near with or without spectacle correction

History of strabismus surgery

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Valproate
  • Placebo
  • Patch

Treatment groups

28 Participants
are divided into 2 treatment groups

Locations

1
Boston Children's Waltham02453, WalthamMassachusetts, United States

Sponsors and collaborators

Boston Children's Hospital

Lead sponsor