Dept. of Ophthalmology, LMU Munich
Munich, 80336, Germany
Completed
NCT Number: NCT01767545
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.
Completed
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Notify MeKey information
Age range
20 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
-
Treatment and study plan
Dexamethasone implant
DrugBevacizumab
DrugPrimary outcomes
-
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
Time frame: 12 months
Secondary outcomes
-
Central retinal thickness
Time frame: 12 months
-
Lens opacity
Time frame: 12 months
-
Saftey of procedure
Time frame: 12 months
Sponsors and collaborators
Lead sponsor
Ludwig-Maximilians - University of Munich
Other
Registry information
Official study title
Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2012
- First posted
- Jan 14, 2013
- Registry last updated
- Jan 14, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.