Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME) (RESPOND)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01135914 |
Recruitment Status
:
Completed
First Posted
: June 3, 2010
Results First Posted
: October 23, 2014
Last Update Posted
: October 23, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Drug: ranibizumab Procedure: Laser | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 241 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | July 2010 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination Therapy
Participants received ranibizumab intravitreal injection and laser photocoagulation treatments
|
Drug: 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.
Procedure: 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.
|
Experimental: Ranibizumab Monotherapy
Participants received ranibizumab intravitreal injection therapy only
|
Drug: 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.
|
Active Comparator: Laser Monotherapy
Participants received Laser photocoagulation therapy only
|
Procedure: 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.
|
- Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12 [ Time Frame: 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.
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 [ Time Frame: 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.
- Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 [ Time Frame: 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 a Gain of 15-letters or More (3-lines) in BCVA From Baseline [ Time Frame: 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.
- Percentage of Patients Achieving Gain of Letters From Baseline in BCVA [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
- Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12 [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135914
Canada, Alberta | |
Calgary Retina Consultants | |
Calgary, Alberta, Canada | |
Canada, British Columbia | |
UBC - Eye Care Center | |
Vancouver, British Columbia, Canada | |
Retina Consultants of Victoria | |
Victoria, British Columbia, Canada | |
Canada, Newfoundland and Labrador | |
Memorial University Health Sciences Centre / Bense Eye Centre | |
St-John's, Newfoundland and Labrador, Canada | |
Canada, Nova Scotia | |
Victoria General Hospital, Department of Ophthalmology | |
Halifax, Nova Scotia, Canada | |
Canada, Ontario | |
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 | |
Canada, Quebec | |
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 | |
Canada, Saskatchewan | |
Saskatoon City Hospital / Spadina Clinic | |
Saskatoon, Saskatchewan, Canada | |
Canada | |
Institut de l'oeil des Laurentides | |
Quebec, Canada | |
Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic | |
St-John's, Canada |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01135914 History of Changes |
Other Study ID Numbers: |
CRFB002DCA05 |
First Posted: | June 3, 2010 Key Record Dates |
Results First Posted: | October 23, 2014 |
Last Update Posted: | October 23, 2014 |
Last Verified: | October 2014 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
DME visual impairment diabetes macular edema diabetic macular edema |
ranibizumab laser photocoagulation retinopathy retina |
Additional relevant MeSH terms:
Edema Macular Edema Vision Disorders Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Ranibizumab Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |