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DHA for Residual Amblyopia
NCT03402789Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jan 2024
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- Johns Hopkins University
- Modality
- Small Molecules
- Drugs
- docosahexaenoic acid
- Conditions
- amblyopia
01
Overview
Phase 2, randomised, double-blind trial in amblyopia comparing DHA Arm with Placebo Arm (2 arms). Primary endpoint: Visual acuity response with DHA at 6 months. Planned start Jan 2024; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
DHA Arm
DHA 1200mg daily + Eye Patching
Placebo Arm
Placebo daily + Eye Patching
03
Who it enrols
Children aged 3 to <18 years with amblyopia associated with strabismus or anisometropia, with visual acuity in the amblyopic eye of 20/50 to 20/400 and sound eye 20/25 or better. Must have had previous or current treatment with patching or atropine and show no recent improvement. Excludes high myopia (>-8.00 D), current vision therapy, or planned strabismus surgery.
04
Endpoints
Primary
Visual acuity response with DHA
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