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Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01512901
First Posted: January 19, 2012
Last Update Posted: July 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.
  Purpose
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion

Condition Intervention Phase
Macular Edema Following Branch Retinal Vein Occlusion Drug: Betamethasone Microsphere (DE-102) Low Dose Drug: Betamethasone Microsphere (DE-102) High Dose Drug: Sham Phase 2 Phase 3

Study Type: Interventional
Official Title: A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score

Secondary Outcome Measures:
  • Change in retinal thickness from baseline

Arms Assigned Interventions
Experimental: 1 Drug: Betamethasone Microsphere (DE-102) Low Dose
Experimental: 2 Drug: Betamethasone Microsphere (DE-102) High Dose
Sham Comparator: 3 Drug: Sham

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 years of age or older
  • Diagnosis of macular edema following branch retinal vein occlusion

Exclusion Criteria:

  • BCVA ETDRS letter score in non-study eye < 35
  • Known steroid-responder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512901


Locations
Japan
Santen study sites
Osaka, Japan
Korea, Republic of
Santen study sites
Seoul, Korea, Republic of
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01512901     History of Changes
Other Study ID Numbers: 01021104
First Submitted: January 15, 2012
First Posted: January 19, 2012
Last Update Posted: July 21, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents