Macular Edema Caused by Retinal Vein Occlusion Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | February 2012 |
| Est. primary completion date | January 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 85 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Dept. of Ophthalmology, LMU Munich | Munich |
| Lead Sponsor | Collaborator |
|---|---|
| Ludwig-Maximilians - University of Munich |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. | 12 months | No | |
| Secondary | Central retinal thickness | 12 months | No | |
| Secondary | Lens opacity | 12 months | No | |
| Secondary | Saftey of procedure | 12 months | No |