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Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO) (COMRADE-C)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01396083
First received: July 14, 2011
Last updated: September 21, 2016
Last verified: September 2016

July 14, 2011
September 21, 2016
August 2011
January 2014   (final data collection date for primary outcome measure)
Mean Average BCVA Change From Month 1 Through Month 6 to Baseline [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity
Measure: mean average BCVA change from Month 1 through Month 6 to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01396083 on ClinicalTrials.gov Archive Site
  • Mean BCVA Change at Month 6 [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
  • Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters [ Time Frame: Baseline, 6 month ] [ Designated as safety issue: No ]
    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
  • Time to Achieve a Significant Improvement ≥ 15 Letters [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
  • Change Over Time in BCVA [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
  • Change Over Time of the Central Retinal Thickness (CRT) [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
  • Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. 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. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function
  • Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
  • Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
  • Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.
  • Measure: mean BCVA change at Month 6 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Measure: percentage of patients gaining / losing ≥ 15 / 10 / 5 letters [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Measure: time to achieve a significant improvement ≥ 15 letters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Measure: change over time of the central retinal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)
A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Central Retinal Vein Occlusion (CRVO)
This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Visual Impairment
  • Macular Edema
  • Central Retinal Vein Occlusion
  • Drug: Ranibizumab
  • Drug: Dexamethasone implant and sham injections
  • Experimental: Ranibizumab
    Intervention: Drug: Ranibizumab
  • Active Comparator: Standard of Care
    Intervention: Drug: Dexamethasone implant and sham injections
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with visual impairment due to macular edema following CRVO
  • Diagnosis of CRVO at maximum 6 months prior to Screening
  • BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion Criteria:

  • Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
  • Central retinal thickness (CRT) < 250 µm in the study eye
  • Prior episode of RVO in the study eye
  • Active formation of new vessels in the study eye
  • Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
  • IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
  • Improvement of > 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Poland,   United Kingdom
Czech Republic
 
NCT01396083
CRFB002EDE18, 2011-001020-38
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2016

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