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This is a randomized, open-label, interventional, controlled study to determine the effects of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control anti-vascular endothelial growth factor ("anti-VEGF") injections (bevacizumab, ranibizumab, or aflibercept).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug Arm | Experimental | Receiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month |
|
| Control Arm | Other | Receiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziv-Aflibercept 25 MG/ML [Zaltrap] | Drug | Anti-VEGF injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of study drug measured by change in best corrected visual acuity | Change in Snellen equivalent letters from baseline to end of study | 18 months |
| Efficacy of study measured by change in central foveal thickness | Change in microns of macular thickness as assessed by Optical Coherence Tomography ("OCT") from baseline to end of study | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of study drug as measured by number of adverse events related to study drug | adverse events, serious adverse events reported causal to drug | 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wagner Macula & Retina Center | Virginia Beach | Virginia | 23454 | United States |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000069579 | Ranibizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab |
| Drug |
Anti-VEGF standard of care injection |
|
|
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |