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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Novartis Investigative Site
Torquay, Devon,, United Kingdom
Novartis Investigative Site
Hull, Hull, United Kingdom
Novartis Investigative Site
Ayr, United Kingdom
The change in mean Best Corrected Visual Acuity (BCVA)
Time frame: Baseline to 12 months
The change in mean Best Corrected Visual Acuity (BCVA)
Time frame: Baseline to 18 months
Occurrence of ocular and systemic adverse events
Time frame: Baseline to 18 months
Time course of changes in BCVA
Time frame: From 6 to 12 and 18 months
Time course of changes in central retinal thickness
Time frame: From baseline and 6 months to 12 and 18 months
Proportion of patients with 10 and 15 letter improvement or loss in BCVA
Time frame: From baseline to 12 and 18 months
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Novartis Investigative Site
Belfast, United Kingdom
Novartis Investigative Site
Birmingham, United Kingdom
Novartis Investigative Site
Cardiff, United Kingdom
Novartis Investigative Site
Colchester, United Kingdom
Novartis Investigative Site
Fife, United Kingdom
Novartis Investigative Site
Great Yarmouth, United Kingdom
Novartis Investigative Site
Liverpool, United Kingdom
...and 5 more locations