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 29, 2014
Last verified: September 2014

July 14, 2011
September 29, 2014
August 2011
January 2014   (final data collection date for primary outcome measure)
Measure: mean average BCVA change from Month 1 through Month 6 to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01396083 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Poland,   United Kingdom
 
NCT01396083
CRFB002EDE18, 2011-001020-38
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

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