The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kita-gun, Kagawa-ken, Japan
Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline
Time frame: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit
Time frame: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3
Time frame: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3
Time frame: 3 months
Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3
Time frame: 3 months
Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Kyoto, Kyoto, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Ohtsu, Shiga, Japan