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

Primary Purpose

Macular Edema Following Branch Retinal Vein Occlusion

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Betamethasone Microsphere (DE-102） Low Dose
Betamethasone Microsphere (DE-102） High Dose
Sham
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Macular Edema Following Branch Retinal Vein Occlusion

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santen study sites
  • Santen study sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

1

2

3

Arm Description

Outcomes

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

Full Information

First Posted
January 15, 2012
Last Updated
July 17, 2014
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01512901
Brief Title
Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Following Branch Retinal Vein Occlusion

7. Study Design

Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Betamethasone Microsphere (DE-102） Low Dose
Intervention Type
Drug
Intervention Name(s)
Betamethasone Microsphere (DE-102） High Dose
Intervention Type
Drug
Intervention Name(s)
Sham
Primary Outcome Measure Information:
Title
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary Outcome Measure Information:
Title
Change in retinal thickness from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan
Facility Name
Santen study sites
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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