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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
The purpose of the study is to determine the effectiveness of Ranibizumab 0.5 mg or 1.0 mg in subjects who were previously treated with Bevacizumab and subsequently switched to Aflibercept. These subjects have demonstrated a sub-optimal therapeutic response to the previous therapies; therefore, the study aims to see if Ranibizumab may have a greater treatment effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab 1 mg | Active Comparator | Subjects will receive Ranibizumab 0.5 mg for 3 doses and then be separated into 2 arms based on initial response. In this Arm (Arm 1), patients will receive 1 mg of Ranibizumab monthly for the remainder of the study, if persistent or worse subretinal fluid with or without intraretinal cysts on SD-OCT is present. |
|
| Ranibizumab 0.5 mg | Active Comparator | Subjects will receive Ranibizumab 0.5 mg for 3 doses and then be separated into 2 arms based on initial response. In this Arm (Arm 2), patients will receive 0.5 mg of Ranibizumab monthly for the remainder of the study, if complete resolution of subretinal fluid on SD-OCT is present. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in vision | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in BCVA | 3 months, 9 months, and 12 months | |
| Mean change in SD-OCT central foveal thickness | 3 months, 6 months, 9 months, and 12 months | |
| Percentage of recalcitrant patients that respond by either OCT or VA to Ranibizumab after not having a complete response to previous therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark R Wieland, MD | Northern California Retina Vitreous Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
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| 12 months |
| Percentage of patients that need to be escalated to 1 mg therapy | 12 months |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| 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 |
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