Valproate for Residual Amblyopia in Children and Adolescents
This study is testing if valproate, a medication often used for epilepsy, can help improve vision in children and adolescents (ages 8-17) with amblyopia (sometimes called "lazy eye"). Participants will receive either valproate or a placebo (an inactive substance that looks like the real medicine) daily for 8 weeks, in addition to standard patching therapy for 2 hours daily for 16 weeks. The main goal is to see if valproate helps improve vision in the amblyopic eye. The study aims to enroll 28 participants and is currently unclear on its recruitment status.
- Study design
- This is a pilot randomized, double-blind, placebo-controlled study involving 28 participants aged 8-17 years.
- What's involved
- You would take daily tablets (valproate or placebo) for 8 weeks and patch your stronger eye for 2 hours daily for 16 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your vision will be compared between groups at the 8-week visit, before any treatment changes.
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NCT07226141
Valproate for the Treatment of Residual Amblyopia
Recruiting
PHASE1Ages 8–17InterventionalTreatmentBoston Children's HospitalInvestigator-initiated
~28 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:ValproatePlaceboPatch
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amblyopic Eye Best-Corrected Visual Acuity (BCVA)
Measured over The comparison will be made between the randomized groups at the 8-week visit, prior to cross-over.
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Eric D Gaier, MD, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 3. 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. 4. 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 5. Spectacle correction for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction \< 6 months old:
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
Myopia of the amblyopic eye \> 0.50 D spherical equivalent must be corrected
Until visual acuity in amblyopic eye has not improved ≥ 1 line (5 letters) by the same testing method during 2 consecutive visual acuity measurements at least 4 weeks apart (i.e. minimum of 8 weeks spectacle correction) ◊ Since this determination is a pre-study examination, the method of visual acuity testing is not mandated 6. Eye examination within 6 months prior to enrollment 7. 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 8. 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
A negative urine pregnancy test will be required for all participants who have experienced menarche at the time of enrollment
Individuals capable of pregnancy must convey an active suitable plan to avoid pregnancy that includes at least one of the following:
Hormonal Contraceptives:
Combined oral contraceptives (the pill)
Contraceptive patch
Vaginal contraceptive ring
Progestin-only pills
Hormonal injections (e.g., Depo-Provera)
Hormonal implants (e.g., Nexplanon)
Intrauterine Devices (IUDs):
Copper IUD (e.g., ParaGard)
Hormonal IUDs (e.g., Mirena, Skyla, Liletta)
Barrier Methods with Spermicide (less commonly used alone but may be used in combination with other methods for added protection):
Male condoms
Female condoms
Diaphragms with spermicide
Cervical caps with spermicide
Sterilization:
Tubal ligation (for females)
Vasectomy (Having a partner who has undergone a vasectomy, confirmed by semen analysis)
Abstinence or True Sexual Abstinence:
Requirements regarding the establishment of pregnancy status and monitoring for pregnancy over the course of the study may be further defined by the IRB
What this trial measures
- Amblyopic Eye Best-Corrected Visual Acuity (BCVA)The comparison will be made between the randomized groups at the 8-week visit, prior to cross-over.
Change in visual acuity of the amblyopic eye after 8 weeks of treatment with valproate plus patching versus placebo plus patching.