Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME) (RESPOND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01135914
First received: May 31, 2010
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: ranibizumab + laser photocoagulation
Drug: ranibizumab
Procedure: laser photocoagulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: mean change from baseline in Best Correct Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: number of patients with visual acuity above 73 letters [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Measure: number of patients with improvement in BCVA [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Measure: time course of BCVA changes [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Measure: change in central retinal thickness and other anatomical changes [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Measure: 15-letter (3-line) gain in BCVA [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: July 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A- ranibizumab plus laser photocoagulation Drug: ranibizumab + laser photocoagulation
Experimental: Group B- monotherapy: ranibizumab Drug: ranibizumab
Active Comparator: Group C- monotherapy: laser photocoagulation Procedure: laser photocoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135914

Locations
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
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St-Michael's Hospital - Dept of Ophthalmology
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Canada, Quebec
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
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01135914     History of Changes
Other Study ID Numbers: CRFB002DCA05
Study First Received: May 31, 2010
Last Updated: April 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on August 18, 2014