Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)
This study is currently recruiting participants.
Verified June 2012 by Santen Pharmaceutical Co., Ltd.
Sponsor:
Santen Pharmaceutical Co., Ltd.
Information provided by:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01411254
First received: August 4, 2011
Last updated: June 7, 2012
Last verified: June 2012
| Tracking Information | |||||
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| First Received Date ICMJE | August 4, 2011 | ||||
| Last Updated Date | June 7, 2012 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Best Corrected Visual Acuity(BCVA) Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01411254 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
retinal thickness Change in retinal thickness from baseline |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA) | ||||
| Official Title ICMJE | A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema | ||||
| Brief Summary | This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Not Provided | ||||
| Condition ICMJE | Diabetic Macular Edema | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01411254 | ||||
| Other Study ID Numbers ICMJE | 01021103 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Santen Pharmaceutical Co., Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Santen Pharmaceutical Co., Ltd. | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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