Completed
NCT Number: NCT01512901
Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion
Completed
Looking for future studies?
Notify MeKey information
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Santen study sites, Osaka, Japan
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Betamethasone Microsphere (DE-102） High Dose
Drugsham
DrugPrimary outcomes
-
Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score
Secondary outcomes
-
Change in retinal thickness from baseline
Sponsors and collaborators
Lead sponsor
Santen Pharmaceutical Co., Ltd.
Industry
Registry information
Official study 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
Important dates
- First posted
- Jan 19, 2012
- Registry last updated
- Jul 21, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.