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

May 31, 2010
April 16, 2013
July 2010
March 2013   (final data collection date for primary outcome measure)
Measure: mean change from baseline in Best Correct Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01135914 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Macular Edema
  • Drug: ranibizumab + laser photocoagulation
  • Drug: ranibizumab
  • Procedure: laser photocoagulation
  • Experimental: Group A- ranibizumab plus laser photocoagulation
    Intervention: Drug: ranibizumab + laser photocoagulation
  • Experimental: Group B- monotherapy: ranibizumab
    Intervention: Drug: ranibizumab
  • Active Comparator: Group C- monotherapy: laser photocoagulation
    Intervention: Procedure: laser photocoagulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
March 2013
March 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01135914
CRFB002DCA05
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP