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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01396083
Phase
PHASE3
Status
Completed

Conditions

  • Central Retinal Vein Occlusion
  • Macular Edema
  • Visual Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
  • Dexamethasone implant and sham injections — DRUG

Study Details

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.

Key Dates

First listed
Jul 18, 2011
Start date
Aug 31, 2011
Status verified
Sep 2016
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

Enrollment
243 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
  • Active Comparator: Standard of Care

Primary Outcome Measure

Mean Average BCVA Change From Month 1 Through Month 6 to Baseline [ Time Frame: Baseline, month 6 ]

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