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Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)

Information source: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema

Intervention: Betamethasone Microsphere (DE-102) Low Dose (Drug); Betamethasone Microsphere (DE-102) High Dose (Drug); Sham (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Santen Pharmaceutical Co., Ltd.

Summary

This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.

Clinical Details

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

Study design: N/A

Primary outcome: Best Corrected Visual Acuity(BCVA)

Secondary outcome: retinal thickness

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Santen study sites, Osaka, Japan
Additional Information


Last updated: July 17, 2014

Page last updated: August 23, 2015

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