Dexamethasone-implant for the Treatment of RVO

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wolfgang Mayer, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01767545
First received: January 9, 2013
Last updated: January 10, 2013
Last verified: January 2013

January 9, 2013
January 10, 2013
September 2010
January 2011   (final data collection date for primary outcome measure)
The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01767545 on ClinicalTrials.gov Archive Site
  • Central retinal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Lens opacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Saftey of procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Macular Edema Caused by Retinal Vein Occlusion
  • Drug: Dexamethasone implant
  • Drug: Bevacizumab
  • Active Comparator: Dexamethasone-implant (Group 1)
    Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
    Intervention: Drug: Dexamethasone implant
  • Active Comparator: Bevacizumab/Dexamethasone-implant (Group 2)
    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.
    Interventions:
    • Drug: Dexamethasone implant
    • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
February 2012
January 2011   (final data collection date for primary outcome measure)

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

-

Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01767545
Mayer-DEX-001
No
Wolfgang Mayer, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Not Provided
Not Provided
Ludwig-Maximilians - University of Munich
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP