Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Macular Edema Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Intervention Type DRUG

Dexamethasone 700 ug intravitreal implant on Day 1.

Interventions

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AGN208397 intravitreal injection

AGN208397 intravitreal injection on Day 1.

Intervention Type DRUG

dexamethasone intravitreal implant

Dexamethasone 700 ug intravitreal implant on Day 1.

Intervention Type DRUG

Other Intervention Names

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Ozurdex®

Eligibility Criteria

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Inclusion Criteria

* macular edema due to retinal vein occlusion
* visual acuity in the study eye between 20/320 to 20/40

Exclusion Criteria

* cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
* use of injectable drugs in the study eye within 2 months prior to day 1
* active eye infection in either eye
* visual acuity in the non-study eye of 20/200 or worse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No