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Trial Information

Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment

Official Title: Ranibizumab Treatment of Diabetic Macular Oedema With Bimonthly Monitoring After a Phase of Initial Treatment. A UK, 18-month, Prospective, Open-label, Multicentre, Single-arm, Phase IIIb Study With 12-month Primary Endpoint, Assessing the Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Diabetic Macular Oedema.

Summary

This study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.The aim of the study is to determine if this treatment regimen is effective and safe in these patients.

Phase: Phase 4

Sponsor: Novartis Pharmaceuticals

Overall Contacts:

Novartis Pharmaceuticals
+41 61 324 1111

Locations (11)

Country State City Zip Facility and Contact
United Kingdom Ayr KA6 6DX Novartis Investigative Site
United Kingdom Belfast BT12 6BA Novartis Investigative Site
United Kingdom Birmingham B9 5SS Novartis Investigative Site
United Kingdom Cardiff, CF14 4XW Novartis Investigative Site
United Kingdom Colchester CO3 3NB Novartis Investigative Site
United Kingdom Fife KY12 OSU Novartis Investigative Site
United Kingdom Hull HU3 2JZ Novartis Investigative Site
United Kingdom Liverpool L7 8XP Novartis Investigative Site
United Kingdom London SE5 9RS Novartis Investigative Site
United Kingdom Rugby CV22 5PX Novartis Investigative Site
United Kingdom York YO31 8HE Novartis Investigative Site

NCT ID:NCT01257815

Date Last Changed: February 7, 2013