Real Life of Aflibercept in France in Patients Refractory to Ranibizumab: Observational Study in Wet AMD

Sponsor
Bayer
Study ID
NCT02321241
Status
Completed

Conditions

  • Wet Macular Degeneration

Eligibility Criteria

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

Interventions

  • Aflibercept (EYLEA, BAY-86-5321) — DRUG
    1. st year: 3 monthly injections followed by 1 injection every two months 2. nd year and following: injection according the visual and anatomical results observed the 1st year

Study Details

The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment. The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab

Key Dates

Start date
Feb 1, 2016
Status verified
Jun 2018
Primary completion
Jan 18, 2017
Completion
Aug 18, 2017

Study Design

Enrollment
236 participants (actual)

Arms

  • Arm: Group 1
    According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection

Primary Outcome Measure

Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm)) [ Time Frame: Between initial visit and 12 month follow up visit ]

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