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

January 15, 2012
July 17, 2014
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Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Same as current
Complete list of historical versions of study NCT01512901 on ClinicalTrials.gov Archive Site
Change in retinal thickness from baseline
Same as current
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Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)
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

This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion

Not Provided
Interventional
Phase 2
Phase 3
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Macular Edema Following Branch Retinal Vein Occlusion
  • Drug: Betamethasone Microsphere (DE-102) Low Dose
  • Drug: Betamethasone Microsphere (DE-102) High Dose
  • Drug: Sham
  • Experimental: 1
    Intervention: Drug: Betamethasone Microsphere (DE-102) Low Dose
  • Experimental: 2
    Intervention: Drug: Betamethasone Microsphere (DE-102) High Dose
  • Sham Comparator: 3
    Intervention: Drug: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of
 
NCT01512901
01021104
Not Provided
Santen Pharmaceutical Co., Ltd.
Santen Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP