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

Macular Edema Following Branch Retinal Vein Occlusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512901
• Other study ID #: 01021104
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 15, 2012
• Last updated: July 17, 2014

Study information

• Verified date: July 2014
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Macular Edema Following Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• Betamethasone Microsphere (DE-102) Low Dose

• Betamethasone Microsphere (DE-102) High Dose

• Sham

Locations

Country	Name	City	State
Japan	Santen study sites	Osaka
Korea, Republic of	Santen study sites	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary	Change in retinal thickness from baseline