Valproate for the Treatment of Residual Amblyopia (NCT07226141) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Valproate for the Treatment of Residual Amblyopia
United States28 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range8 Years – 17 Years
SexALL
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Inclusion criteria
✓. Age 8-17 years
✓. Amblyopia associated with strabismus and/or anisometropia
✓. Visual acuity measured in each eye within 7 days prior to enrollment using ETDRS protocol on a study certified visual acuity tester as follows:
✓. Current amblyopia treatment (other than spectacle correction)
✓. Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction \< 6 months old:
✓. Eye examination within 6 months prior to enrollment
✓. Subject must be available for at least 6 months of follow-up, have access to a phone, and be willing to be contacted by clinical staff
✓. By investigator judgment, the subject is likely to comply with prescribed treatment (i.e. no prior history of poor compliance with patching) and unlikely to continue to improve with 2 hours of daily patching alone
Exclusion criteria
What they're measuring
1
Amblyopic Eye Best-Corrected Visual Acuity (BCVA)
Timeframe: The comparison will be made between the randomized groups at the 8-week visit, prior to cross-over.