NCT01257815

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Retinopathy
• Macular Oedema

Interventions

Type	Name	Description
DRUG	Ranibizumab

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-12-10
• Last updated: 2014-09-30

Locations

15 sites across 1 country: United Kingdom