Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

121

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Mar 2010

Typical duration for phase_1

Geographic Reach

5 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

December 4, 2009

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2009

Completed

3 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

April 29, 2014

Completed

Last Updated

April 29, 2014

Status Verified

March 1, 2014

Enrollment Period

2.1 years

First QC Date

December 4, 2009

Results QC Date

March 27, 2014

Last Update Submit

March 27, 2014

Conditions

Macular Edema Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (4)

Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
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.
Baseline, Month 1
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by 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.
Baseline, Month 1
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Baseline, Month 1
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Baseline, Month 1

Secondary Outcomes (4)

Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Baseline, Month 12
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
Baseline, Month 12