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This study seeks to compare dexamethasone implant with rescue intravitreal ranibizumab to monthly intravitreal ranibizumab for the treatment of macular edema secondary to branch or central retinal vein occlusion. This is based on the null hypothesis that dexamethasone implant with rescue ranibizumab has inferior best corrected visual acuity at six months compared to monthly ranibizumab alone.
Dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) and Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) as needed group:
Monthly Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly Ranibizumab | Active Comparator | • Patients will receive a ranibizumab intravitreal injection on day 0. During each other visit, patients will receive a ranibizumab intravitreal injection. The protocol will use the term "monthly" to represent a 30 day interval between treatments. |
|
| Dexamethasone intravitreal implant | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone intravitreal implant | Drug | Patients will receive a Dexamethasone implant and ranibizumab, as needed. A comparison will be made between ranibizumab and Dexamethasone implant with rescue ranibizumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | • Primary outcome: Mean change from baseline in best corrected visual acuity score | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Foveal Thickness |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brianna Kenney | Contact | research@midatlanticretina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Retina Service | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Monthly Ranibizumab | Drug | 30 days between treatments |
|
|
| 6 months |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |