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This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone Microsphere (DE-102） Low Dose | Drug |
| ||
| Betamethasone Microsphere (DE-102） High Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity(BCVA) | Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score |
| Measure | Description | Time Frame |
|---|---|---|
| retinal thickness | Change in retinal thickness from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santen study sites | Osaka | Osaka | Japan |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Drug |
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| Sham | Drug |
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