Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
RESPOND
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.
1 other identifier
interventional
241
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2010
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
October 23, 2014
CompletedOctober 23, 2014
October 1, 2014
2.7 years
May 31, 2010
March 19, 2014
October 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12
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.
Baseline and 12 months
Secondary Outcomes (7)
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9
Baseline, 3, 6 and 9 months
Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12
Baseline, 3, 6, 9 and 12 months
Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline
Baseline, 3, 6, 9 and 12 months
Percentage of Patients Achieving Gain of Letters From Baseline in BCVA
12 months
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12
12 month
- +2 more secondary outcomes
Study Arms (3)
Combination Therapy
EXPERIMENTALParticipants received ranibizumab intravitreal injection and laser photocoagulation treatments
Ranibizumab Monotherapy
EXPERIMENTALParticipants received ranibizumab intravitreal injection therapy only
Laser Monotherapy
ACTIVE COMPARATORParticipants received Laser photocoagulation therapy only
Interventions
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.
Eligibility Criteria
You may qualify if:
- Stable Type 1 or Type 2 diabetes mellitus
- Visual impairment due to focal or diffuse DME in at least one eye
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2010
First Posted
June 3, 2010
Study Start
July 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
October 23, 2014
Results First Posted
October 23, 2014
Record last verified: 2014-10