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Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00464685
First received: April 20, 2007
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.


Condition Intervention Phase
Diabetic Macular Edema
 Drug: Dexamethasone
Drug: Sham injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Visual Acuity [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Macular Thickness (OCT) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Vessel leakage (FA) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Time to retreatment [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: May 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dexamethasone
Intravitreal injection of Dexamethasone; 700 µg every 6 months; up to 2 doses
Other Name: Posurdex
Sham Comparator: 2 Drug: Sham injection
Sham injection every 6 months; up to 2 doses

  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older with diabetic macular edema
  • 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

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
  • 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: NCT00464685

Locations
United States, California
Artesia, California, United States
Canada, British Columbia
Victoria, British Columbia, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00464685     History of Changes
Other Study ID Numbers: 206207-012
Study First Received: April 20, 2007
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye 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
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013