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Completed

NCT Number: NCT01411254

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

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

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Key information

Conditions

Diabetic Macular Edema

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Santen study sites

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone Microsphere (DE-102） Low Dose

Drug

Betamethasone Microsphere (DE-102） High Dose

Drug

sham

Drug

Primary outcomes

  1. Best Corrected Visual Acuity(BCVA)

    Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score

Secondary outcomes

  1. retinal thickness

    Change in retinal thickness from baseline

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

First posted
Aug 8, 2011
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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