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

• Status: Completed
• Trial end date: 2017-08-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept; Ranibizumab

Criteria

Inclusion Criteria:

• Man or woman > 18 years old

• Patient with wAMD previously treated with ranibizumab (for less than 12 months before initiation of Aflibercept)

• Refractory to ranibizumab (defined by persistent fluid despite a treatment conducted according to the HAS French recommendations with at least 3 loading doses injections)

• Patient who switched to aflibercept (Eylea) between 1st of January 2014 and 30th June 2015

• Written informed consent given

Exclusion Criteria:

• Patient who do not meet the local indication criteria for aflibercept treatment. Contraindications listed in the local SmPC (Summary of Product Characteristics) have to be considered

• Recurrent patients with wAMD previously treated with ranibizumab and switched to aflibercept because of a high recurrence rate (recurrent patients described by Yonegawa et al.in AJO (American Journal of Ophthalmology )2013= exudation suppressed but high rate of injections)

• Patient who have been previously treated by any macular laser Visudyne/PD (Photodynamic therapy)

• Patient with a Visual Acuity (VA) <1/10

• Patient with Fibrosis involving Macula

• Patient with atrophic AMD

• Patient with any other retinal disease as myopia, diabetic retinopathy, diabetic macular oedema,chorioretinal anastomosis (CRA),, angioid streaks

• Patients taking part in an interventional study at the time of enrolment