Trial record 3 of 7 for:
Open Studies | "Amblyopia"
Treatment of Residual Amblyopia With Donepezil
This study is currently recruiting participants.
Verified December 2012 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01584076
First received: April 23, 2012
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
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 acetylcholine, a neurotransmitter, 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amblyopia |
Drug: Donepezil Other: Patching |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Recovery From Amblyopia With Cholinesterase Inhibitors |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Boston:
Primary Outcome Measures:
- Amblyopia Eye Visual Acuity Improvement [ Time Frame: 22 weeks after enrollment ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Amblyopic Eye Visual Acuity [ Time Frame: 4, 8, 12, and 22 weeks after enrollment ] [ Designated as safety issue: No ]Analysis of amblyopia eye visual acuity measured at each visit.
- Recurrence of Amblyopia after 10 Weeks Off Study Treatment [ Time Frame: 22 weeks after enrollment ] [ Designated as safety issue: No ]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.
- Adverse Events [ Time Frame: 4, 8, 12, and 22 weeks after enrollment ] [ Designated as safety issue: Yes ]Analysis of the proportion of subjects reporting adverse events.
- Adverse Events Requiring Discontinuation of Study Treatment [ Time Frame: 4, 8, and 12 weeks after enrollment ] [ Designated as safety issue: Yes ]Analysis of the proportion of subjects requiring discontinuation of study treatment secondary to adverse events.
- Completion of Study Treatment [ Time Frame: 12 weeks after enrollment ] [ Designated as safety issue: Yes ]Analysis of the proportion of subjects completing study treatment.
- Sound Eye Visual Acuity [ Time Frame: 22 weeks after enrollment ] [ Designated as safety issue: Yes ]Analysis of sound eye visual acuity at 22 weeks to assess any adverse effect on the occluded eye.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Donepezil |
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 Name: Aricept
Other: Patching
Patching: 2 hours of daily patching will also be prescribed for 8 to 17 year olds only.
|
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥8 years
- Amblyopia associated with strabismus and/or anisometropia
- Amblyopic eye visual acuity of 20/50 - 20/400
- Sound eye visual acuity of ≥20/25
- 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)
- For ≥18 year olds, history of prior amblyopia treatment with patching
- 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)
- Complete eye examination within 6 months prior to enrollment
- Available for at least 6 months of follow-up, have access to a phone, and willing to be contacted by clinical staff
- Likely to comply with prescribed treatment and unlikely, if applicable, to continue to improve with 2 hours of daily patching alone
Exclusion Criteria:
- Myopia more than -6.00 D spherical equivalent
- Presence of associated findings that could cause reduced visual acuity
- Previous intraocular or refractive surgery
- Strabismus surgery planned within 22 weeks
- Current vision therapy or orthoptics
- Treatment with topical atropine within the past 4 weeks
- Presence of cardiac condition, asthma, obstructive pulmonary disease, seizure disorder, urinary incontinence, and/or peptic ulcer disease receiving concurrent NSAIDs
- History of gastrointestinal bleeding from peptic ulcer disease
- Known psychological problems
- Known skin reaction to patch or bandage adhesives for 8 to 17 year olds
- Known allergies or contraindications to the use of acetylcholinesterase inhibitors
- Prior acetylcholinesterase inhibitor treatment
- Current use of medication for the treatment of ADHD or psychological disorders
- Inability to swallow pills equivalent in size to the 5 mg donepezil tablet
- Females who are pregnant, lactating, or intending to become pregnant within the next 6 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584076
Contacts
| Contact: Caitlin Rook, OC(C) | 781-216-1463 | caitlin.rook@childrens.harvard.edu |
| Contact: Carolyn Wu, MD | 617-355-8761 | carolyn.wu@childrens.harvard.edu |
Locations
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Caitlin Rook, OC(C) 781-216-1463 caitlin.rook@childrens.harvard.edu | |
| Contact: Carolyn Wu, MD 617-355-8761 carolyn.wu@childrens.harvard.edu | |
| Boston Children's Hospital at Waltham | Recruiting |
| Waltham, Massachusetts, United States, 02453 | |
| Contact: Caitlin Rook, OC(C) 781-216-1463 caitlin.rook@childrens.harvard.edu | |
| Contact: Carolyn Wu, MD 617-355-8761 carolyn.wu@childrens.harvard.edu | |
| Boston Children's Physicians South | Recruiting |
| Weymouth, Massachusetts, United States, 02190 | |
| Contact: Caitlin Rook, OC(C) 781-216-1463 caitlin.rook@childrens.harvard.edu | |
| Contact: Carolyn Wu, MD 617-355-8761 carolyn.wu@childrens.harvard.edu | |
Sponsors and Collaborators
Children's Hospital Boston
Investigators
| Principal Investigator: | Carolyn Wu, MD | Boston Children's Hospital |
| Principal Investigator: | David G. Hunter, MD, PhD | Boston Children's Hospital |
More Information
Publications:
| Responsible Party: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01584076 History of Changes |
| Other Study ID Numbers: | IRB-P00002887 |
| Study First Received: | April 23, 2012 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital Boston:
|
Amblyopia Donepezil |
Additional relevant MeSH terms:
|
Amblyopia Brain Diseases Central Nervous System Diseases Nervous System Diseases Vision Disorders Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms Cholinesterase Inhibitors |
Donepezil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013