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Inadequate enrollment due to investigational product becoming newly available on the Canadian market soon after study start
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SHIFT-2 is a national, multi-center, non-randomized, open label trial of aflibercept in patients with wet age related macular degeneration who have incomplete response with routineranibizumab treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept | Experimental | Aflibercept 2 mg (0.05 mL or 50 microliters) will be administered by intravitreal injection every 4 weeks for the first 8 weeks, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks for 36 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Aflibercept 2 mg (0.05 mL or 50 microliters) will be administered by intravitreal injection every 4 weeks for the first 8 weeks, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks for 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT | After 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT | 16 weeks after treatment | |
| Change in central retinal thickness (CRT) | Weeks 12, 16, and 48 | |
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Inclusion Criteria:
Note: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Brent, MD, FRCSC | Unity Health Toronto | Principal Investigator |
| Rajeev Muni, MD, FRCSC | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary Retina Consultants | Calgary | Alberta | T2H 0C8 | Canada | ||
| Alberta Retina Consultants |
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| Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity |
| Week 12, 16, and 48 |
| Edmonton |
| Alberta |
| T5H 0X5 |
| Canada |
| Capital District Health Authority | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| St. Joseph's Centre for Ambulatory Services | Hamilton | Ontario | L8G 5E4 | Canada |
| Hotel Dieu Hospital / Queen's | Kingston | Ontario | K7L 5G2 | Canada |
| Ivey Eye Institute | London | Ontario | N6A 4V2 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Saskatoon Retina Consultants | Saskatoon | Saskatchewan | S7S 0A7 | Canada |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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