Clinical trial NCT01135914: Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
Official title: A Canadian 12-month, Prospective, Randomized, Open-label, Multicenter, Laser-controlled Phase IIIb Study Assessing the Efficacy, Safety and Cost-efficacy of Ranibizumab as Combination and Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: DME
visual impairment
diabetes
macular edema
diabetic macular edema
ranibizumab
laser
photocoagulation
retinopathy
retina
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.


Eligibility criteria: Inclusion Criteria:

* Stable Type 1 or Type 2 diabetes mellitus
* Visual impairment due to focal or diffuse DME in at least one eye

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9
timeFrame: Baseline, 3, 6 and 9 months
measure: Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline
timeFrame: Baseline, 3, 6, 9 and 12 months
measure: Percentage of Patients Achieving Gain of Letters From Baseline in BCVA
timeFrame: 12 months
measure: National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12
timeFrame: 12 month
measure: EuroQoL (EQ-5D) Utility Score at Month 12
timeFrame: 12 month
measure: Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12
timeFrame: 12 month
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Vancouver
country: Canada
facility: UBC - Eye Care Center
state: British Columbia
city: Victoria
country: Canada
facility: Retina Consultants of Victoria
state: British Columbia
city: St-John's
country: Canada
facility: Memorial University Health Sciences Centre / Bense Eye Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Victoria General Hospital, Department of Ophthalmology
state: Nova Scotia
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Mississauga
country: Canada
facility: Canadian Centre for Advanced Eye Therapeutics
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Toronto
country: Canada
facility: St-Michael's Hospital - Dept of Ophthalmology
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Drummondville
country: Canada
facility: Clinique ChirurgiVision
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Notre Dame (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Québec
country: Canada
facility: Centre Oculaire de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: Dr.Michel Giunta Clinique Médicale
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon City Hospital / Spadina Clinic
state: Saskatchewan
city: Quebec
country: Canada
facility: Institut de l'oeil des Laurentides
city: St-John's
country: Canada
facility: Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: