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NCT01584076 · ClinicalTrials.gov registry record · Phase 1
Treatment of Residual Amblyopia With Donepezil
A Phase 1 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01584076: Completed Phase 1 study, sponsored by Boston Children's Hospital.
NCT01584076 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01584076, a Phase 1 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Patching
- DRUG Donepezil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-08 |
| Est. Completion | 2021-01 |
| Phase | Phase 1 |
What the finished NCT01584076 record still lists
NCT01584076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Patching is the first listed.
NCT01584076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01584076 about?
NCT01584076 is a clinical study titled "Treatment of Residual Amblyopia With Donepezil". 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 ...
What is the current status of trial NCT01584076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-08. Estimated completion is 2021-01.
What interventions are being tested in trial NCT01584076?
The interventions under investigation include: Patching (OTHER), Donepezil (DRUG).
Who is sponsoring clinical trial NCT01584076?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01584076's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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