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

NCT ID: NCT01411254

Last Updated: 2014-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Groups

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1

Group Type EXPERIMENTAL

Betamethasone Microsphere (DE-102) Low Dose

Intervention Type DRUG

2

Group Type EXPERIMENTAL

Betamethasone Microsphere (DE-102) High Dose

Intervention Type DRUG

3

Group Type SHAM_COMPARATOR

Sham

Intervention Type DRUG

Interventions

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Betamethasone Microsphere (DE-102) Low Dose

Intervention Type DRUG

Betamethasone Microsphere (DE-102) High Dose

Intervention Type DRUG

Sham

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Locations

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Santen study sites

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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01021103

Identifier Type: -

Identifier Source: org_study_id

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