NCT01584076

Treatment of Residual Amblyopia With Donepezil

Recovery From Amblyopia With Cholinesterase Inhibitors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DRUG	Donepezil	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.
OTHER	Patching	Patching: 2 hours of daily patching will also be prescribed for 8 to 17 year olds only.

Timeline

• Start date: 2012-08-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2012-04-24
• Last updated: 2021-06-18

Locations

3 sites across 1 country: United States