Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
NCT ID: NCT01135914
Last Updated: 2014-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
241 participants
INTERVENTIONAL
2010-07-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination Therapy
Participants received ranibizumab intravitreal injection and laser photocoagulation treatments
ranibizumab
Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.
Laser
Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.
Ranibizumab Monotherapy
Participants received ranibizumab intravitreal injection therapy only
ranibizumab
Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.
Laser Monotherapy
Participants received Laser photocoagulation therapy only
Laser
Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.
Interventions
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ranibizumab
Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.
Laser
Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.
Eligibility Criteria
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Inclusion Criteria
* Visual impairment due to focal or diffuse DME in at least one eye
Exclusion Criteria
* Active eye infection or inflammation
* History of stroke, renal failure or uncontrolled hypertension
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Calgary Retina Consultants
Calgary, Alberta, Canada
UBC - Eye Care Center
Vancouver, British Columbia, Canada
Retina Consultants of Victoria
Victoria, British Columbia, Canada
Memorial University Health Sciences Centre / Bense Eye Centre
St. John's, Newfoundland and Labrador, Canada
Victoria General Hospital, Department of Ophthalmology
Halifax, Nova Scotia, Canada
Ivey Eye Institute
London, Ontario, Canada
Canadian Centre for Advanced Eye Therapeutics
Mississauga, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
St-Michael's Hospital - Dept of Ophthalmology
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Clinique ChirurgiVision
Drummondville, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hôpital Notre Dame (CHUM)
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Centre Oculaire de Québec
Québec, Quebec, Canada
Dr.Michel Giunta Clinique Médicale
Sherbrooke, Quebec, Canada
Saskatoon City Hospital / Spadina Clinic
Saskatoon, Saskatchewan, Canada
Institut de l'oeil des Laurentides
Québec, , Canada
Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic
St. John's, , Canada
Countries
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Other Identifiers
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CRFB002DCA05
Identifier Type: -
Identifier Source: org_study_id
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