Valproate for the Treatment of Residual Amblyopia

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Amblyopia, Amblyopia Unilateral, Amblyopia, Anisometropic, Amblyopia Strabismic

In brief

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.

Key facts

Study ID

NCT07226141

Run by

Boston Children's Hospital

People needed

28

Starts

2026-07-01

Expected to finish

2027-09-30

Last updated by the study team

2026-07-30

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 8-17 years
• Amblyopia associated with strabismus and/or anisometropia
• Criteria for strabismus: must meet at least one of the following:
• Heterotropia at distance and/or near with or without spectacle correction
• History of strabismus surgery
• Documented history of strabismus that is no longer present and felt by the investigator could have caused the amblyopia
• Criteria for anisometropia: must meet at least one of the following:
• ≥ 0.50 D difference in spherical equivalent between eyes
• ≥ 1.50 D difference in astigmatism in any meridian between the eyes
• Visual acuity measured in each eye within 7 days prior to enrollment using ETDRS protocol on a study certified visual acuity tester as follows:
• Amblyopic eye visual acuity of 20/40 - 20/400
• Sound eye acuity of ≥ 20/25.
• Current amblyopia treatment (other than spectacle correction)
• Subjects actively patching at the time of enrollment screening should continue patching through enrollment
• Visual acuity in amblyopic eye has not improved ≥ 1 line (5 letters) by the same testing method from a previous visit ≥ 8 weeks earlier while on treatment
• Since this determination is a pre-study examination, the method of visual acuity testing is not mandated
• Atropine treatment at any time during this pre-enrollment period is not allowed
• Any treatment prior to the current patching episode with stable acuity is allowed
• Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction < 6 months old:
• Requirement for spectacle correction:
• Spherical equivalent must be within 0.50 D of fully correcting anisometropia
• Hyperopia ≥ 3.00 D must be corrected
• Hyperopia may not be undercorrected by > 1.50 D spherical equivalent and must be symmetrically reduced in each eye
• Cylinder power must be within 0.50 D of fully correcting the astigmatism
• Cylinder axis must be within 6 degrees of the axis in the spectacles when the cylinder power is ≥ 1.00 D

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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