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NCT01027650 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
A Phase 1 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
NCT01027650 is a Phase 1 study that has completed, run by Allergan. The registered enrollment target is 121 participants.
The verdict
NCT01027650, a Phase 1 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.
Interventions
- DRUG dexamethasone intravitreal implant
- DRUG AGN208397 intravitreal injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01027650
The ClinicalTrials.gov registry entry for NCT01027650 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which dexamethasone intravitreal implant is the first listed.
NCT01027650 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01027650 about?
NCT01027650 is a clinical study titled "Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)". This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal...
What is the current status of trial NCT01027650?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2010-03. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01027650?
The interventions under investigation include: dexamethasone intravitreal implant (DRUG), AGN208397 intravitreal injection (DRUG).
Who is sponsoring clinical trial NCT01027650?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
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