Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
- Registration Number
- NCT01135914
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
- Stable Type 1 or Type 2 diabetes mellitus
- Visual impairment due to focal or diffuse DME in at least one eye
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Therapy Laser Participants received ranibizumab intravitreal injection and laser photocoagulation treatments Laser Monotherapy Laser Participants received Laser photocoagulation therapy only Combination Therapy ranibizumab Participants received ranibizumab intravitreal injection and laser photocoagulation treatments Ranibizumab Monotherapy ranibizumab Participants received ranibizumab intravitreal injection therapy only
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12 Baseline and 12 months Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 Baseline, 3, 6 and 9 months Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.
Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline Baseline, 3, 6, 9 and 12 months Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response.
Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12 12 month (TTO) questionnaire was used to help determine the patients' health utility. Reported health utility represents the patients' quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision.
Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 Baseline, 3, 6, 9 and 12 months OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment
Percentage of Patients Achieving Gain of Letters From Baseline in BCVA 12 months Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement.
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12 12 month The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed
EuroQoL (EQ-5D) Utility Score at Month 12 12 month The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1="no problems", 2="some problems" and 3="extreme problems". Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health).
Trial Locations
- Locations (20)
Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic
🇨🇦St-John's, Canada
Dr.Michel Giunta Clinique Médicale
🇨🇦Sherbrooke, Quebec, Canada
Saskatoon City Hospital / Spadina Clinic
🇨🇦Saskatoon, Saskatchewan, Canada
Institut de l'oeil des Laurentides
🇨🇦Quebec, Canada
Calgary Retina Consultants
🇨🇦Calgary, Alberta, Canada
UBC - Eye Care Center
🇨🇦Vancouver, British Columbia, Canada
Retina Consultants of Victoria
🇨🇦Victoria, British Columbia, Canada
Victoria General Hospital, Department of Ophthalmology
🇨🇦Halifax, Nova Scotia, Canada
Canadian Centre for Advanced Eye Therapeutics
🇨🇦Mississauga, Ontario, Canada
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Clinique ChirurgiVision
🇨🇦Drummondville, Quebec, Canada
Hôpital Notre Dame (CHUM)
🇨🇦Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Centre Oculaire de Québec
🇨🇦Québec, Quebec, Canada
Ivey Eye Institute
🇨🇦London, Ontario, Canada
St-Michael's Hospital - Dept of Ophthalmology
🇨🇦Toronto, Ontario, Canada
Memorial University Health Sciences Centre / Bense Eye Centre
🇨🇦St-John's, Newfoundland and Labrador, Canada