Status:
COMPLETED
Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagula...
Eligibility Criteria
Inclusion
- Stable Type 1 or Type 2 diabetes mellitus
- Visual impairment due to focal or diffuse DME in at least one eye
Exclusion
- Active conditions in the study eye that could prevent the improvement of visual acuity on study treatment
- Active eye infection or inflammation
- History of stroke, renal failure or uncontrolled hypertension
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01135914
Start Date
July 1 2010
End Date
March 1 2013
Last Update
October 23 2014
Active Locations (20)
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1
Calgary Retina Consultants
Calgary, Alberta, Canada
2
UBC - Eye Care Center
Vancouver, British Columbia, Canada
3
Retina Consultants of Victoria
Victoria, British Columbia, Canada
4
Memorial University Health Sciences Centre / Bense Eye Centre
St. John's, Newfoundland and Labrador, Canada