Back to resultsDexamethasone-implant for the Treatment of RVO
Primary Purpose
Macular Edema Caused by Retinal Vein Occlusion
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Dexamethasone implant
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema Caused by Retinal Vein Occlusion
Eligibility Criteria
Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -
Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis
-
Sites / Locations
- Dept. of Ophthalmology, LMU Munich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone-implant (Group 1)
Bevacizumab/Dexamethasone-implant (Group 2)
Arm Description
Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
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.
Outcomes
Primary Outcome Measures
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
Secondary Outcome Measures
Central retinal thickness
Lens opacity
Saftey of procedure
Full Information
NCT ID
NCT01767545
First Posted
January 9, 2013
Last Updated
January 10, 2013
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01767545
Brief Title
Dexamethasone-implant for the Treatment of RVO
Official Title
Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Caused by Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone-implant (Group 1)
Arm Type
Active Comparator
Arm Description
Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
Arm Title
Bevacizumab/Dexamethasone-implant (Group 2)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone implant
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Primary Outcome Measure Information:
Title
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Central retinal thickness
Time Frame
12 months
Title
Lens opacity
Time Frame
12 months
Title
Saftey of procedure
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -
Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis
-
Facility Information:
Facility Name
Dept. of Ophthalmology, LMU Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Dexamethasone-implant for the Treatment of RVO
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