Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01958918
Phase
PHASE4
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

Key Dates

Start date
Oct 23, 2013
Status verified
Dec 2018
Primary completion
Nov 22, 2016
Completion
May 29, 2017

Study Design

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

Arms

  • Experimental: Ranibizumab
    1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity
  • Active Comparator: Aflibercept
    1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months

Primary Outcome Measure

Mean of the Absolute Values of CSRT Difference Month 3 to Month 6 [ Time Frame: Month 3, Month 4, Month 5, Month 6 ]

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