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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

September 12, 2005
July 15, 2009
November 2004
March 2008   (final data collection date for primary outcome measure)
Best Correctd Visual Acuity (BCVA) [ Time Frame: Day 0 - Day 180 ] [ Designated as safety issue: No ]
visual acuity
Complete list of historical versions of study NCT00168298 on ClinicalTrials.gov Archive Site
  • 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 ]
macular thickness
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Not Provided

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Macular Edema
  • Retinal Vein Occlusion
  • Drug: Dexamethasone
    700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity at baseline and month 6
    Other Name: Posurdex®
  • Drug: Dexamethasone
    350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity at baseline
    Other Name: Posurdex®
  • Other: Sham injection
    Sham injection at baseline
  • Active Comparator: 1
    Intervention: Drug: Dexamethasone
  • Active Comparator: 2
    Intervention: Drug: Dexamethasone
  • Sham Comparator: 3
    Intervention: Other: Sham injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
668
August 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT00168298
206207-009
Not Provided
Therapeutic Area Head, Allergan, Inc.
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP