A Clinical Study in Current Medical Practice of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01315275
Phase
PHASE4
Status
Completed

Conditions

  • Macular Edema
  • Visual Impairment

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.

Key Dates

First listed
Mar 15, 2011
Start date
Feb 28, 2011
Status verified
Feb 2017
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
394 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab

Primary Outcome Measure

proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) [ Time Frame: 6 months ]

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