drugset / Trial / NCT01767545

Dexamethasone-implant for the Treatment of RVO

NCT01767545

Phase 4 Completed 64 enrolled Ludwig-Maximilians - University of Munich
Non-randomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2010-09
Primary completion
2011-01
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody
Comparator Dexamethasone Small molecule