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NCT01190813 · ClinicalTrials.gov registry record · Phase 3
Levodopa for the Treatment of Residual Amblyopia
A Phase 3 study of Amblyopia, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
- 1
- Study location
NCT01190813: Completed Phase 3 study of Amblyopia, sponsored by Jaeb Center for Health Research.
NCT01190813 is a Phase 3 study of Amblyopia that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 139 participants, below the 160-participant average among 24 other Amblyopia trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190813, a Phase 3 study of Amblyopia, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to \<13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.
Primary Outcome
The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity prot
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Patching
- DRUG Levodopa/Carbidopa
Study Locations (1)
Maryland
- Wilmer Eye Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01190813 record still lists
NCT01190813 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 160-participant average among 24 other Amblyopia trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Amblyopia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01190813 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01190813 about?
NCT01190813 is a clinical study titled "Levodopa for the Treatment of Residual Amblyopia". The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to \<13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.
What is the current status of trial NCT01190813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2010-09. Estimated completion is 2014-04.
What conditions does trial NCT01190813 study?
This clinical trial studies the following conditions: Amblyopia.
What interventions are being tested in trial NCT01190813?
The interventions under investigation include: Placebo (DRUG), Patching (OTHER), Levodopa/Carbidopa (DRUG).
Who is sponsoring clinical trial NCT01190813?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01190813 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amblyopia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01190813's enrollment target sits among peer trials
139 12th of 24 higher than 13 of 24 other Amblyopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amblyopia 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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A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
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Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children
COMPLETED · Phase 3
-
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
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