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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. There will be approximately 50 men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part in this study at 5 locations in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Variable Treatment Dosing Arm | Active Comparator | Group 1 will receive injections every 4 weeks until diabetic macular edema on the OCT is decreased and stable. At that point, the length of time between injections may increase, depending on how the study eye is doing. The interval between study eye treatments may maintain, increase, or decrease once the variable treatment dosing has begun. This will be determined by an algorithm designed into a computer program |
|
| Monthly Treatment Arm | Active Comparator | Group 2 will receive 5 intravitreal injections, monthly, for the first 5 months of the study. After those initial injections, visits/treatment will be every 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Aflibercept Injection | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| BCVA Change | Change in mean BCVA from baseline to week 52 | Week 0 to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilsher S Dhoot, MD | California Retina Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants - Bakersfield | Bakersfield | California | 93039 | United States | ||
| California Retina Consultants - Santa Barbara Office |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Santa Barbara |
| California |
| 93103 |
| United States |