A Safety and Efficacy Study of OZURDEX® in Macular Edema Associated With Branch Retinal Vein Occlusion
Overview
- Phase
- Phase 4
- Intervention
- dexamethasone implant
- Conditions
- Macular Edema
- Sponsor
- Allergan
- Enrollment
- 71
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of OZURDEX® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of macular edema
- •Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye
Exclusion Criteria
- •Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
- •Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
- •Any active ocular infection in either eye
Arms & Interventions
OZURDEX®
OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Intervention: dexamethasone implant
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6
Time Frame: Baseline, Month 6
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.
Secondary Outcomes
- Percentage of Participants Receiving a Third Injection(12 Months)
- Time to Third Injection(12 Months)
- Change From Baseline in CRT at Month 12(Baseline, Month 12)
- Change From Baseline in CRT at Each Visit(Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Change From Baseline in Central Retinal Thickness (CRT) at Month 6(Baseline, Month 6)
- Change From Baseline in BCVA at Month 12(Baseline, Month 12)
- Change From Baseline in BCVA at Each Visit(Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA(Baseline, Months 6 and 12)
- Percentage of Participants Receiving a Second Injection(12 Months)
- Time to Second Injection(12 Months)
- Percentage of Participants Who Received Laser Treatments(12 Months)