A Phase 1 interventional study of Donepezil and Patching in Amblyopia, sponsored by Boston Children's Hospital. Completed at 3 sites in United States. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Boston Children's Hospital · Phase 1, Interventional, and Treatment
Amblyopia is the leading cause of monocular visual impairment in children and adults. Despite conventional treatment with patching or eye drops, many older children and adults do not achieve normal vision in the amblyopic eye.
Donepezil is an acetylcholinesterase inhibitor that increases levels of the neurotransmitter acetylcholine in the brain. Use of acetylcholinesterase inhibitors has been demonstrated by the Hensch lab (Department of Neurology, FM Kirby Neurobiology Center) at Boston Children's Hospital to improve vision and reverse amblyopia in animal models.
The purpose of this study is to evaluate the efficacy of oral donepezil as treatment for residual amblyopia (20/50 - 20/400) in patients 8 years of age and older.
183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 133 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Donepezil · Other: Patching
Oral Donepezil Daily Initial Dosage: Donepezil 5 mg tablets will be used. 1/2 tablet (≈2.5 mg)/day for 8 to 17 year olds OR 1 tablet (5 mg)/day for ≥18 year olds. Dosage Escalation: Donepezil may be increased by 1/2 tablet (≈2.5 mg)/day every 4 weeks if the amblyopic eye visual acuity has not improved by ≥5 letters or 1 logMAR line to a maximum dosage of 1 1/2 tablets (≈7.5 mg)/day for 8 to 17 year olds OR 2 tablets (10 mg)/day for ≥18 year olds.
Also known as: Aricept
Patching: 2 hours of daily patching will also be prescribed for 8 to 17 year olds only.
Amblyopia Eye Visual Acuity Improvement
Study treatment will last for 12 weeks. Primary outcome measure is analysis of the proportion of subjects with improvement in amblyopic eye visual acuity of ≥ 15 letters or 3 logMAR lines at 22 weeks after 10 weeks off study treatment.
Time frame: 22 weeks after enrollment
Amblyopic Eye Visual Acuity
Analysis of amblyopia eye visual acuity measured at each visit.
Time frame: 4, 8, 12, and 22 weeks after enrollment
Recurrence of Amblyopia after 10 Weeks Off Study Treatment
Study treatment will be discontinued after 12 weeks. Amblyopic eye visual acuity at 12 weeks and 22 weeks will be compared. Analysis of the proportion of subjects with recurrence of amblyopia after 10 weeks off study treatment.
Time frame: 22 weeks after enrollment
Adverse Events
Analysis of the proportion of subjects reporting adverse events.
Time frame: 4, 8, 12, and 22 weeks after enrollment
Adverse Events Requiring Discontinuation of Study Treatment
Analysis of the proportion of subjects requiring discontinuation of study treatment secondary to adverse events.
Time frame: 4, 8, and 12 weeks after enrollment
Completion of Study Treatment
Analysis of the proportion of subjects completing study treatment.
Time frame: 12 weeks after enrollment
Sound Eye Visual Acuity
Analysis of sound eye visual acuity at 22 weeks to assess any adverse effect on the occluded eye.
Time frame: 22 weeks after enrollment
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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