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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01257815
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Dec 10, 2010
Start date
Jan 31, 2011
Status verified
Sep 2014
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
111 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab 0.5mg

Primary Outcome Measure

The change in mean Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline to 12 months ]

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