A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02130024
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study was to compare the development of new geographic atrophy in patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result in the progressive and irreversible loss of visual function over time.

Key Dates

Start date
Apr 11, 2014
Status verified
Oct 2018
Primary completion
Nov 15, 2017
Completion
Nov 15, 2017

Study Design

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

Arms

  • Experimental: Ranibizumab 0.5 mg
    3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
  • Active Comparator: Aflibercept 2.0 mg
    3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]

Primary Outcome Measure

Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24 [ Time Frame: Baseline, Month 24 ]

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