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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Macular Edema; Retinal Vein Occlusion	Drug: AGN208397 intravitreal injection; Drug: dexamethasone intravitreal implant	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	121 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Study Start Date :	March 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	February 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Ozurdex®

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Phoenix, Arizona, United States
Australia, Victoria
East Melbourne, Victoria, Australia
Canada, Ontario
London, Ontario, Canada
Israel
Tel Aviv, Israel
South Africa
Cape Town, South Africa

Sponsors and Collaborators

Allergan

Investigators

Study Director:	Medical Director	Allergan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01027650 History of Changes
Other Study ID Numbers:	208397-001
First Posted:	December 8, 2009
Results First Posted:	April 29, 2014
Last Update Posted:	April 29, 2014
Last Verified:	March 2014

Additional relevant MeSH terms:

Edema; Macular Edema; Retinal Vein Occlusion; Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Dexamethasone acetate; Dexamethasone	BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action