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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01027650
First received: December 4, 2009
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  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
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • Retinal Thickness [ Time Frame: Month 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinal Thickness [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 122
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
 Drug: AGN208397 intravitreal injection
Stage 1 Open label single dose 75 ug sterile intravitreal injection
Experimental: Stage 1 Cohort 2
AGN208397 intravitreal injection 300 ug
 Drug: AGN208397 intravitreal injection
Stage 1 Open label single dose 300 ug sterile intravitreal injection
Experimental: Stage 1 Cohort 3
AGN208397 intravitreal injection 600 ug
 Drug: AGN208397 intravitreal injection
Stage 1 Open label single dose 600 ug sterile intravitreal injection
Experimental: Stage 1 Cohort 4
AGN208397 intravitreal injection 900 ug
 Drug: AGN208397 intravitreal injection
Stage 1 Open label single dose 900 ug sterile intravitreal injection
Experimental: Stage 2 Arm 1
AGN208397 intravitreal injection (dose to be selected from Stage 1)
 Drug: AGN208397 intravitreal injection
Stage 2 Single dose (dose to be selected from Stage 1) sterile intravitreal injection
Experimental: Stage 2 Arm 2
AGN208397 intravitreal injection (dose to be selected from Stage 1)
 Drug: AGN208397 intravitreal injection
Stage 2 Single dose (dose to be selected from Stage 1) sterile intravitreal injection
Experimental: Stage 2 Arm 3
AGN208397 intravitreal injection (dose to be selected from Stage 1)
 Drug: AGN208397 intravitreal injection
Stage 2 Single dose (dose to be selected from Stage 1) sterile intravitreal injection
Active Comparator: Stage 2 Arm 4
dexamethasone 700 ug intravitreal implant
 Drug: dexamethasone intravitreal implant
Stage 2 Single dose dexamethasone 700 ug intravitreal implant
Other Name: Ozurdex®

  Eligibility

Ages Eligible for Study:   18 Years and older
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
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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01027650     History of Changes
Other Study ID Numbers: 208397-001
Study First Received: December 4, 2009
Last Updated: April 19, 2013
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
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 22, 2013