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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VTE 2Q4 first, then VTE 2Q8 | Experimental | VEGF Trap-Eye [BAY86-5321; EYLEA (aflibercept) Injection] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEGF Trap-Eye (BAY86-5321) | Biological | Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event collection | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BCVA (best corrected visual acuity) letter score | Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matsuyama | Ehime | 790-8524 | Japan | |||
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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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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Maebashi |
| Gunma |
| 371-8511 |
| Japan |
| Kobe | Hyōgo | 650-0017 | Japan |
| Mito | Ibaraki | 310-0015 | Japan |
| Kita | Kagawa-ken | 761-0793 | Japan |
| Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Kawasaki | Kanagawa | 216-8511 | Japan |
| Kyoto | Kyoto | 606-8507 | Japan |
| Sendai | Miyagi | 984-8560 | Japan |
| Kashihara | Nara | 634-8522 | Japan |
| Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka | Osaka | 537-0025 | Japan |
| Osaka | Osaka | 558-8558 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Saga | Saga-ken | 840-8571 | Japan |
| Ōtsu | Shiga | 520-2192 | Japan |
| Shimotsuke | Tochigi | 329-0498 | Japan |
| Wakayama | Wakayama | 641-8510 | Japan |