Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01948830
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab 0.5mg — DRUG
    0.5 mg ranibizumab (intravitreal injections) prefilled syringe)
  • Ranibizumab 0.5mg — DRUG
    0.5 mg ranibizumab (intravitreal injections) prefilled syringe)

Study Details

This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

Key Dates

First listed
Sep 24, 2013
Start date
Dec 17, 2013
Status verified
Mar 2017
Primary completion
Nov 19, 2015
Completion
Nov 19, 2015

Study Design

Enrollment
650 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Group I ranibizumab 0.5 mg monthly
    Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) up to month 11
  • Active Comparator: Group II ranibizumab 0.5 mg TER
    Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen up to month 11

Primary Outcome Measure

Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 [ Time Frame: Baseline to month 12 ]

Related Studies