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A 12-month, Phase IV, Open-label, Randomized, Active Controlled, 2-arm, Multicenter Study Assessing the Efficacy and Safety of Intravitreal Ranibizumab Combined With Grid&Direct Short Pulse Laser Photocoagulation Versus a PRN Ranibizumab Monotherapy in Japanese Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
This is a Phase IV, randomized, open-label, active-controlled, 2-arm, multicenter study. The primary objective was assessed by the difference in the mean number of ranibizumab injections applied up to Month 11 between the 2 treatment arms. Patients were randomized in a 1:1 ratio to 1 of the 2 treatment arms; i.e. Arm 1 ranibizumab monotherapy, Arm 2 ranibizumab with Grid\&Direct short pulse laser photocoagulation combination therapy. There were 3 periods in this study: Screening Period (visit 1), Treatment Period (visit 2 to Visit 13) and Follow-up Period (visit 14). In addition to screening and Baseline (visit 2), there were monthly visits from Month 1 to Month 12. This study included male and female patients (≥20 years old) diagnosed with visual impairment due to ME secondary to BRVO.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Nagakute, Aichi-ken, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Kita-gun, Kagawa-ken, Japan
Novartis Investigative Site
Tsu, Mie-ken, Japan
Novartis Investigative Site
Matsumoto, Nagano, Japan
Novartis Investigative Site
Mitaka, Tokyo, Japan
Novartis Investigative Site
Hokkaido, Japan
Start Date
December 15, 2016
Primary Completion Date
December 28, 2018
Completion Date
December 28, 2018
Last Updated
February 25, 2020
59
ACTUAL participants
Ranibizumab
BIOLOGICAL
Grid&Direct short pulse laser photocoagulation
RADIATION
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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