A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
- Conditions
- Retinal Vein OcclusionMacular Edema
- Interventions
- Registration Number
- NCT00168298
- Lead Sponsor
- Allergan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 668
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 350 µg Dexamethasone followed by 700 µg Dexamethasone 700 µg Dexamethasone 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. 350 µg Dexamethasone followed by 700 µg Dexamethasone 350 µg Dexamethasone 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. Sham Injection followed by 700 µg Dexamethasone Sham Injection Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. 700 µg Dexamethasone 700 µg Dexamethasone 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. Sham Injection followed by 700 µg Dexamethasone 700 µg Dexamethasone Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
- Primary Outcome Measures
Name Time Method Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye Day 180 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Retinal Thickness in the Study Eye Baseline, Day 90, Day 180 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 Baseline, Day 180 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.