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NCT01492400 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 363
- Enrollment target
NCT01492400: Completed Phase 2 study, sponsored by Allergan.
NCT01492400 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 363 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (173% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01492400, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 363 participants
- Enrollment target
Study Summary
This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).
Primary Outcome
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Interventions
- DRUG ranibizumab
- DRUG dexamethasone Intravitreal Implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2012-03-09 |
| Est. Completion | 2014-02-13 |
| Phase | Phase 2 |
What the finished NCT01492400 record still lists
NCT01492400 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (173% higher).
The record links to 0 conditions, and to 2 interventions - of which ranibizumab is the first listed.
NCT01492400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01492400 about?
NCT01492400 is a clinical study titled "Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema". This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).
What is the current status of trial NCT01492400?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 363 participants. The study started on 2012-03-09. Estimated completion is 2014-02-13.
What interventions are being tested in trial NCT01492400?
The interventions under investigation include: ranibizumab (DRUG), dexamethasone Intravitreal Implant (DRUG).
Who is sponsoring clinical trial NCT01492400?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01492400's enrollment target sits among peer trials
363 122nd of 2000 higher than 1,879 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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