Valproate for the Treatment of Residual Amblyopia

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorBoston Children's Hospital

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

Sponsors and collaborators