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

March 27, 2014 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 1 Cohort 1
AGN208397 intravitreal injection 75 ug on Day 1.
Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug on Day 1.
Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug on Day 1.
Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug on Day 1.
Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 2 Arm 1
AGN208397 intravitreal injection 600 ug on Day 1.
Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 2 Arm 2
AGN208397 intravitreal injection 450 ug on Day 1.
Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Experimental: Stage 2 Arm 3
AGN208397 intravitreal injection 300 ug on Day 1.
Drug: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Active Comparator: Stage 2 Arm 4
Dexamethasone 700 ug intravitreal implant on Day 1.
Drug: dexamethasone intravitreal implant
Dexamethasone 700 ug intravitreal implant on Day 1.
Other Names:
  • Ozurdex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Time Frame: Baseline, Month 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
Time Frame: Baseline, Month 1
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
Time Frame: Baseline, Month 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
Time Frame: Baseline, Month 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Time Frame: Baseline, Month 12
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 12
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Time Frame: Baseline, Month 12
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 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
Time Frame: Baseline, Month 12
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 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
Time Frame: Baseline, Month 12
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 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimate)

December 8, 2009

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

March 27, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208397-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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