Dexamethasone-implant for the Treatment of RVO
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.
Macular Edema Caused by Retinal Vein Occlusion
Drug: Dexamethasone implant
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion|
- The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Central retinal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Lens opacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Saftey of procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
|Drug: Dexamethasone implant|
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.
|Drug: Dexamethasone implant Drug: Bevacizumab|