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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01512901
First received: January 15, 2012
Last updated: July 17, 2014
Last verified: July 2014
  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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01512901     History of Changes
Other Study ID Numbers: 01021104
Study First Received: January 15, 2012
Last Updated: July 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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-17,21-dipropionate
Betamethasone benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014