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Treatment of Residual Amblyopia With Donepezil

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amblyopia

Intervention: Donepezil (Drug); Patching (Other)

Phase: Phase 1

Status: Recruiting

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Carolyn Wu, MD, Principal Investigator, Affiliation: Children's Hospital Boston
David G. Hunter, MD, PhD, Principal Investigator, Affiliation: Children's Hospital Boston
Bharti Gangwani, MD, Principal Investigator, Affiliation: Children's Hospital Boston

Overall contact:
Sarah Whitecross, OC(C), Phone: 781-216-1463, Email: sarah.whitecross@childrens.harvard.edu

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.

Clinical Details

Official title: Recovery From Amblyopia With Cholinesterase Inhibitors

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Amblyopia Eye Visual Acuity Improvement

Secondary outcome:

Amblyopic Eye Visual Acuity

Recurrence of Amblyopia after 10 Weeks Off Study Treatment

Adverse Events

Adverse Events Requiring Discontinuation of Study Treatment

Completion of Study Treatment

Sound Eye Visual Acuity

Eligibility

Minimum age: 8 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age ≥8 years 2. Amblyopia associated with strabismus and/or anisometropia

3. Amblyopic eye visual acuity of 20/50 - 20/400

4. Sound eye visual acuity of ≥20/25 5. For 8 to 17 year olds, current amblyopia treatment of at least 2 hours of daily patching for at least 4 weeks during the pre-enrollment period with no improvement in best-corrected amblyopic eye visual acuity (<5 letters or 1 logMAR line between 2 consecutive visual acuity measurements at least 4 weeks apart while on current treatment) 6. For ≥18 year olds, history of prior amblyopia treatment with patching 7. Wearing optimal optical correction with stable amblyopic eye visual acuity (<5 letters or 1 logMAR line of improvement during 2 consecutive visual acuity measurements at least 4 weeks apart) 8. Complete eye examination within 6 months prior to enrollment 9. Available for at least 6 months of follow-up, have access to a phone, and willing to be contacted by clinical staff 10. Likely to comply with prescribed treatment and unlikely, if applicable, to continue to improve with 2 hours of daily patching alone Exclusion Criteria:

1. Myopia more than - 6. 00 D spherical equivalent

2. Presence of associated findings that could cause reduced visual acuity 3. Previous intraocular or refractive surgery 4. Strabismus surgery planned within 22 weeks 5. Current vision therapy or orthoptics 6. Treatment with topical atropine within the past 4 weeks 7. Presence of cardiac condition, asthma, obstructive pulmonary disease, seizure disorder, urinary incontinence, and/or peptic ulcer disease receiving concurrent NSAIDs 8. History of gastrointestinal bleeding from peptic ulcer disease 9. Known psychological problems 10. Known skin reaction to patch or bandage adhesives for 8 to 17 year olds 11. Known allergies or contraindications to the use of acetylcholinesterase inhibitors 12. Prior acetylcholinesterase inhibitor treatment 13. Current use of medication for the treatment of ADHD or psychological disorders 14. Inability to swallow pills equivalent in size to the 5 mg donepezil tablet 15. Females who are pregnant, lactating, or intending to become pregnant within the next 6 months

Locations and Contacts

Sarah Whitecross, OC(C), Phone: 781-216-1463, Email: sarah.whitecross@childrens.harvard.edu

Boston Children's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Sarah Whitecross, OC(C), Phone: 781-216-1463, Email: sarah.whitecross@childrens.harvard.edu
Carolyn Wu, MD, Phone: 617-355-5685, Email: carolyn.wu@childrens.harvard.edu
Carolyn Wu, MD, Principal Investigator
David Hunter, MD, PhD, Principal Investigator
Bharti Gangwani, MD, Sub-Investigator

Boston Children's Hospital at Waltham, Waltham, Massachusetts 02453, United States; Recruiting
Sarah Whitecross, OC(C), Phone: 781-216-1463, Email: sarah.whitecross@childrens.harvard.edu
Carolyn Wu, MD, Phone: 617-355-8761, Email: carolyn.wu@childrens.harvard.edu
Carolyn Wu, MD, Principal Investigator
David Hunter, MD, PhD, Principal Investigator
Bharti Gangwani, MD, Sub-Investigator

Boston Children's Physicians South, Weymouth, Massachusetts 02190, United States; Recruiting
Sarah Whitecross, OC(C), Phone: 781-216-1463, Email: sarah.whitecross@childrens.harvard.edu
Carolyn Wu, MD, Phone: 617-355-8761, Email: carolyn.wu@childrens.harvard.edu
Carolyn Wu, MD, Principal Investigator
David Hunter, MD, PhD, Principal Investigator
Bharti Gangwani, MD, Sub-Investigator

Additional Information

Related publications:

Morishita H, Miwa JM, Heintz N, Hensch TK. Lynx1, a cholinergic brake, limits plasticity in adult visual cortex. Science. 2010 Nov 26;330(6008):1238-40. doi: 10.1126/science.1195320. Epub 2010 Nov 11.

Starting date: August 2012
Last updated: July 31, 2015

Page last updated: August 20, 2015

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