Phase 2/3 Study of SK-0503 in Patients with Macular Edema Following Branch Retinal Vein Occlusio
- Conditions
- Macular edema following branch retinal vein occlusion
- Registration Number
- JPRN-jRCT2080221159
- Lead Sponsor
- SANWA KAGAKU KENKYUSHO Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients with macular edema that developed in the study eye from 52 weeks (364 days) to 6 weeks (42 days) prior to qualification/baseline visit
(2) Patients whose best corrected visual acuity is between 34 and 68 letters inclusive in the study eye as measured by the ETDRS method
(3) Patients with a central macular retinal thickness of at least 350 µm in the study eye as measured by optical coherence tomography
(1) Patients whose BCVA score of less than 34 letters measured by the ETDRS method at qualification/baseline visit
(2) Patients with a history of steroid-induced intraocular pressure elevation
(3) Patients with diabetic retinopathy
(4) Patients with cancer, serious liver disease, serious renal disease, or serious heart disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method