NCT01767545

Dexamethasone-implant for the Treatment of RVO

Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Edema Caused by Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Dexamethasone implant
DRUG	Bevacizumab

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-01-01
• Completion: 2012-02-01
• First posted: 2013-01-14
• Last updated: 2013-01-14

Locations

1 site across 1 country: Germany