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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone-implant (Group 1) | Active Comparator | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone implant | Drug |
| ||
| Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central retinal thickness | 12 months | |
| Lens opacity | 12 months | |
| Saftey of procedure |
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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
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Ophthalmology, LMU Munich | Munich | 80336 | Germany |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
|
| 12 months |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |