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 (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00168298
First received: September 12, 2005
Last updated: July 15, 2013
Last verified: July 2013

September 12, 2005
July 15, 2013
November 2004
March 2008   (final data collection date for primary outcome measure)
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Day 180 ] [ 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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
visual acuity
Complete list of historical versions of study NCT00168298 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Retinal Thickness in the Study Eye [ Time Frame: Baseline, Day 90, Day 180 ] [ 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.
  • Percentage of Patients With a Change From Baseline in BCVA by Category [ Time Frame: Baseline, Day 90 ] [ 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
  • Percentage of Patients With a Change From Baseline in BCVA by Category [ Time Frame: Baseline, Day 180 ] [ 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
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: 700 µg Dexamethasone
    700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
    Other Name: Posurdex®
  • Drug: 350 µg Dexamethasone
    350 µg Dexamethasone intravitreal implant administered on Day 0.
    Other Name: Posurdex®
  • Other: Sham Injection
    Sham injection on Day 0.
  • Experimental: 700 µg Dexamethasone
    700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
    Intervention: Drug: 700 µg Dexamethasone
  • Experimental: 350 µg Dexamethasone followed by 700 µg Dexamethasone
    350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
    Interventions:
    • Drug: 700 µg Dexamethasone
    • Drug: 350 µg Dexamethasone
  • Sham Comparator: Sham Injection followed by 700 µg Dexamethasone
    Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
    Interventions:
    • Drug: 700 µg Dexamethasone
    • 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
September 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
Italy,   Brazil,   Canada,   Colombia,   Hong Kong,   India,   United Kingdom,   Korea, Republic of,   New Zealand,   Poland,   Singapore,   Spain,   United States
 
NCT00168298
206207-009
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2013

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