Last updated on October 2017

Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety


Brief description of study

This is a Phase IV, randomized, open-label, active-controlled, 2-arm, multicenter study. The primary objective will be assessed by the difference in the mean number of ranibizumab injections applied up to Month 11 between the 2 treatment arms. Patients will be 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 will be 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 will be monthly visits from Month 1 to Month 12. This study will include male and female patients (≥20 years old) diagnosed with visual impairment due to ME secondary to BRVO. Assuming an approximate 20% drop out rate, approximately 70 patients will need to be screened to have at least 56 patients found eligible and commencing treatment in the trial.

Clinical Study Identifier: NCT02953938

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Novartis Pharmaceuticals

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Nagakute-city, Japan
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Fukuoka city, Japan
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Kita-gun, Japan
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Tsu-city, Japan
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Matsumoto-city, Japan
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Mitaka-city, Japan
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Novartis Investigative Site
Hokkaido, Japan
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