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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01396057
Phase
PHASE3
Status
Completed

Conditions

  • Branch Retinal Vein Occlusion
  • Macular Edema
  • Visual Impairment

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split
  • Dexamethasone Implant — OTHER
    Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.
  • Sham injection — OTHER
    Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration

Study Details

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab 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
Jul 31, 2011
Status verified
Aug 2014
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

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

Arms

  • Experimental: Ranibizumab
    Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
  • Sham Comparator: Dexamethasone
    Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months

Primary Outcome Measure

Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline [ Time Frame: Baseline, month 6 ]

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