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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01512901
Enrollment
Unknown
Registered
2012-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2014-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema Following Branch Retinal Vein Occlusion

Brief summary

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

Interventions

DRUGBetamethasone Microsphere (DE-102） Low Dose
DRUGBetamethasone Microsphere (DE-102） High Dose
DRUGSham

Sponsors

Santen Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score—

Secondary

MeasureTime frame
Change in retinal thickness from baseline—

Countries

Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026