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

Phase 2

Completed

• Conditions: Macular Edema Following Branch Retinal Vein Occlusion
• Interventions: Drug: Betamethasone Microsphere (DE-102） Low Dose; Drug: Betamethasone Microsphere (DE-102） High Dose; Drug: Sham

• Registration Number: NCT01512901
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-15
• Study First Submitted QC: 2012-01-15
• Study First Posted: 2012-01-19
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Betamethasone Microsphere (DE-102） Low Dose	-
2	Betamethasone Microsphere (DE-102） High Dose	-
3	Sham	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in retinal thickness from baseline

Trial Locations

Locations (1)

Santen study sites; 🇰🇷 Seoul, Korea, Republic of