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

Purpose

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	Intervention	Phase
Macular Edema Retinal Vein Occlusion	Drug: AGN208397 intravitreal injection Drug: dexamethasone intravitreal implant	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 [ Time Frame: Baseline, Month 1 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 [ Time Frame: Baseline, Month 1 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 [ Time Frame: Baseline, Month 1 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 [ Time Frame: Baseline, Month 1 ] [ Designated as safety issue: No ]
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:

Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
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.
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
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.


Enrollment:	121
Study Start Date:	March 2010
Study Completion Date:	February 2013
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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®

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027650

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


Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01027650 History of Changes
Other Study ID Numbers:	208397-001
Study First Received:	December 4, 2009
Results First Received:	March 27, 2014
Last Updated:	March 27, 2014
Health Authority:	United States: Food and Drug Administration

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	Dexamethasone 21-phosphate 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

ClinicalTrials.gov processed this record on September 23, 2016