Dexamethasone-implant for the Treatment of RVO

Phase 4

Completed

• Conditions: Macular Edema Caused by Retinal Vein Occlusion
• Interventions: Drug: Dexamethasone implant; Drug: Bevacizumab

• Registration Number: NCT01767545
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-01
• Study Completion: 2012-02
• Status Verified: 2013-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Study First Posted: 2013-01-14
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -

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Exclusion Criteria

Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dexamethasone-implant (Group 1)	Dexamethasone implant	Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
Bevacizumab/Dexamethasone-implant (Group 2)	Dexamethasone implant	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.
Bevacizumab/Dexamethasone-implant (Group 2)	Bevacizumab	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 Measures

Name	Time	Method
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.	12 months

Secondary Outcome Measures

Name	Time	Method
Lens opacity	12 months
Central retinal thickness	12 months
Saftey of procedure	12 months

Trial Locations

Locations (1)

Dept. of Ophthalmology, LMU Munich; 🇩🇪 Munich, Germany