- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135914
Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME) (RESPOND)
October 22, 2014 updated by: Novartis Pharmaceuticals
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada
- Institut de l'Oeil des Laurentides
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St-John's, Canada
- Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic
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Alberta
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Calgary, Alberta, Canada
- Calgary Retina Consultants
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British Columbia
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Vancouver, British Columbia, Canada
- UBC - Eye Care Center
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Victoria, British Columbia, Canada
- Retina Consultants of Victoria
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Newfoundland and Labrador
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St-John's, Newfoundland and Labrador, Canada
- Memorial University Health Sciences Centre / Bense Eye Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Victoria General Hospital, Department of Ophthalmology
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Ontario
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London, Ontario, Canada
- Ivey Eye Institute
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Mississauga, Ontario, Canada
- Canadian Centre for Advanced Eye Therapeutics
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Ottawa, Ontario, Canada
- The Ottawa Hospital - General Campus
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada
- Toronto Western Hospital
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Toronto, Ontario, Canada
- St-Michael's Hospital - Dept of Ophthalmology
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Quebec
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Drummondville, Quebec, Canada
- Clinique ChirurgiVision
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Montreal, Quebec, Canada
- Hopital Maisonneuve-Rosemont
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Montreal, Quebec, Canada
- Royal Victoria Hospital
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Montreal, Quebec, Canada
- Hôpital Notre Dame (CHUM)
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Québec, Quebec, Canada
- Centre Oculaire de Quebec
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Sherbrooke, Quebec, Canada
- Dr.Michel Giunta Clinique Médicale
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Saskatoon City Hospital / Spadina Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Combination Therapy
Participants received ranibizumab intravitreal injection and laser photocoagulation treatments
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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 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.
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EXPERIMENTAL: Ranibizumab Monotherapy
Participants received ranibizumab intravitreal injection therapy only
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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.
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ACTIVE_COMPARATOR: Laser Monotherapy
Participants received Laser photocoagulation therapy only
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9
Time Frame: Baseline, 3, 6 and 9 months
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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.
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Baseline, 3, 6 and 9 months
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Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12
Time Frame: Baseline, 3, 6, 9 and 12 months
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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
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Baseline, 3, 6, 9 and 12 months
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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
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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.
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Baseline, 3, 6, 9 and 12 months
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Percentage of Patients Achieving Gain of Letters From Baseline in BCVA
Time Frame: 12 months
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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.
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12 months
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National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12
Time Frame: 12 month
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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
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12 month
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EuroQoL (EQ-5D) Utility Score at Month 12
Time Frame: 12 month
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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).
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12 month
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Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12
Time Frame: 12 month
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(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.
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12 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
March 1, 2013
Study Registration Dates
First Submitted
May 31, 2010
First Submitted That Met QC Criteria
May 31, 2010
First Posted (ESTIMATE)
June 3, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
October 23, 2014
Last Update Submitted That Met QC Criteria
October 22, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRFB002DCA05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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