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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: Completed Phase 1 study, sponsored by Allergan.
NCT01027650 is a Phase 1 study that has completed, run by Allergan. The registered enrollment target is 121 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
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 |
What the finished NCT01027650 record still lists
NCT01027650 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 2 interventions - of which dexamethasone intravitreal implant is the first listed.
NCT01027650 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01027650's enrollment target sits among peer trials
121 476th of 2000 higher than 1,522 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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