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Trial record 1 of 1 for:    NCT01584076
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Treatment of Residual Amblyopia With Donepezil

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Children's Hospital Boston
Sponsor:
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

April 23, 2012
December 21, 2012
August 2012
February 2014   (final data collection date for primary outcome measure)
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.
Amblyopic Eye Visual Acuity [ Time Frame: 22 weeks after randomization ] [ Designated as safety issue: No ]
Study treatment (patching and oral medication) will last for 12 weeks. Primary outcome is treatment group comparison of the amblyopia eye visual acuity measured at 22 weeks after 10 weeks off treatment.
Complete list of historical versions of study NCT01584076 on ClinicalTrials.gov Archive Site
  • 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.
  • Amblyopia Eye Visual Acuity Improvement [ Time Frame: 4, 8, 12, and 22 weeks after randomization ] [ Designated as safety issue: No ]
    Treatment group comparison of the proportion of subjects with improvement in amblyopic eye visual acuity of ≥ 10 letters.
  • Recurrence of Amblyopia after 10 Weeks Off Treatment [ Time Frame: 12 and 22 weeks after randomization ] [ Designated as safety issue: No ]
    Study treatment (patching and oral medication) will be discontinued after 12 weeks. Amblyopic eye visual acuity at 12 weeks and 22 weeks after randomization will be compared. Treatment group comparison of the proportion of subjects with recurrence of amblyopia after 10 weeks off treatment.
  • Sound Eye Visual Acuity [ Time Frame: 22 weeks after randomization ] [ Designated as safety issue: Yes ]
    Sound eye visual acuity will be evaluated at 22 weeks to assess any adverse effect on the occluded eye.
  • Adverse Events [ Time Frame: 4, 8, 12, and 22 weeks after randomization ] [ Designated as safety issue: Yes ]
    Treatment group comparison of the proportion of subjects reporting adverse events.
  • Adverse Events Requiring Discontinuation of Treatment [ Time Frame: 4, 8, and 12 weeks after randomization ] [ Designated as safety issue: Yes ]
    Treatment group comparison of the proportion of subjects requiring discontinuation of treatment secondary to adverse events.
  • Completion of Treatment [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: Yes ]
    Treatment group comparison of the proportion of subjects completing treatment.
Not Provided
Not Provided
 
Treatment of Residual Amblyopia With Donepezil
Recovery From Amblyopia With Cholinesterase Inhibitors

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Amblyopia
  • 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.
Experimental: Donepezil
Interventions:
  • Drug: Donepezil
  • Other: Patching
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
8 Years and older
No
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
United States
 
NCT01584076
IRB-P00002887
No
Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Carolyn Wu, MD Children's Hospital Boston
Principal Investigator: David G. Hunter, MD, PhD Children's Hospital Boston
Children's Hospital Boston
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP