Diabetic Macular Edema Clinical Trial
Official title:
A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema
| NCT number | NCT01411254 |
| Other study ID # | 01021103 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| First received | August 4, 2011 |
| Last updated | July 17, 2014 |
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Provided signed, written informed consent - 20 years of age or older with diabetic macular edema Exclusion Criteria: - Active proliferative diabetic retinopathies (PDR) in the study eye - Uncontrolled diabetes mellitus and hypertension - Known steroid-responder |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Japan | Santen study sites | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Santen Pharmaceutical Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Best Corrected Visual Acuity(BCVA) | Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score | ||
| Secondary | retinal thickness | Change in retinal thickness from baseline |
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