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

Santen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Macular Edema Following Branch Retinal Vein Occlusion

Treatments: Drug: Betamethasone Microsphere (DE-102） High Dose; Drug: Sham; Drug: Betamethasone Microsphere (DE-102） Low Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01512901

01021104

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

0 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Betamethasone Microsphere (DE-102） Low Dose

2

Experimental group

Treatment:

Drug: Betamethasone Microsphere (DE-102） High Dose

3

Sham Comparator group

Treatment:

Drug: Sham