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A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00168298
First received: September 12, 2005
Last updated: July 15, 2009
Last verified: July 2009
History of Changes
  Purpose

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.


Condition Intervention Phase
Macular Edema
Retinal Vein Occlusion
 Drug: Dexamethasone
Other: Sham injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, 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 Correctd Visual Acuity (BCVA) [ Time Frame: Day 0 - Day 180 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
  • Contrast Sensitivity [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
  • Macular Thickness (OCT) [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
  • Vessel Leakage (FA) [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaires [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]

Enrollment: 668
Study Start Date: November 2004
Study Completion Date: August 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Dexamethasone
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity at baseline and month 6
Other Name: Posurdex®
Active Comparator: 2 Drug: Dexamethasone
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity at baseline
Other Name: Posurdex®
Sham Comparator: 3 Other: Sham injection
Sham injection at baseline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 18 years of age or older with macular edema resulting from retinal vein occlusion
  • Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
  • Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

  • Known anticipated need for ocular surgery within next 12 months
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Diabetic retinopathy
  • Uncontrolled systemic disease
  • Known steroid-responder
  • Use of systemic steroids
  • Use of warfarin/heparin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168298

Locations
United States, Texas
Houston, Texas, United States
Canada, Ontario
Mississauga, Ontario, Canada
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00168298     History of Changes
Other Study ID Numbers: 206207-009
Study First Received: September 12, 2005
Results First Received: July 15, 2009
Last Updated: July 15, 2009
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 23, 2013