Status:
COMPLETED
A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study
Lead Sponsor:
Novartis
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with vis...
Eligibility Criteria
Inclusion
- Visual acuity impairment
- Diabetic macular edema in at least one eye
- Type 1 or type 2 diabetes mellitus
- Medication for the diabetes treatment must be stable for the last 3 months
Exclusion
- Patients with uncontrolled systemic or ocular diseases
- Laser photocoagulation in the study eye for the last 3 months
- Any history of any intraocular surgery in the study eye within the past 3 months
- Blood pressure \> 160/100 mmHg
- Extension Inclusion Criteria:
- Completion of the Core Study
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00687804
Start Date
May 1 2008
End Date
January 1 2012
Last Update
April 1 2013
Active Locations (13)
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1
Novartis Investigative Site
Melbourne, Australia
2
Novartis Investigative Site
Leuven, Belgium
3
Novartis Investigative Site
Ontario, Canada
4
Novartis Investigative Site
Paris, France