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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: October 22, 2014
Last verified: October 2014

May 31, 2010
October 22, 2014
July 2010
March 2013   (final data collection date for primary outcome measure)
Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
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.
Measure: mean change from baseline in Best Correct Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01135914 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 [ Time Frame: Baseline, 3, 6 and 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    (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.
  • 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 ]
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
    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: Combination Therapy
    Participants received ranibizumab intravitreal injection and laser photocoagulation treatments
    Interventions:
    • Drug: ranibizumab
    • Procedure: Laser
  • Experimental: Ranibizumab Monotherapy
    Participants received ranibizumab intravitreal injection therapy only
    Intervention: Drug: ranibizumab
  • Active Comparator: Laser Monotherapy
    Participants received Laser photocoagulation therapy only
    Intervention: Procedure: Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
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
October 2014

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