Dexamethasone-implant for the Treatment of RVO
- Sponsor
- Ludwig-Maximilians - University of Munich
- Study ID
- NCT01767545
- Phase
- PHASE4
- Status
- Completed
Conditions
- Macular Edema Caused by Retinal Vein Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dexamethasone implant — DRUG
- Bevacizumab — DRUG
Study Details
To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.
Key Dates
- First listed
- Jan 14, 2013
- Start date
- Sep 30, 2010
- Status verified
- Jan 2013
- Primary completion
- Jan 31, 2011
- Completion
- Feb 29, 2012
Study Design
- Enrollment
- 64 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Dexamethasone-implant (Group 1)Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
- Active Comparator: Bevacizumab/Dexamethasone-implant (Group 2)Group 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection.
Primary Outcome Measure
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. [ Time Frame: 12 months ]