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

Bayer

Status: Completed

Conditions: Wet Macular Degeneration

Treatments: Drug: Aflibercept (EYLEA, BAY-86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT02321241

EY1413FR (Other Identifier)

17405

Details and patient eligibility

About

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

Full description

The study is both retrsopective and prospective to collect local real life data on patients under routine treatment.

The observation periods starts on January 2014. Patients who initiated a treatment by Aflibercept between the 1st of january 2014 and the 31 December 2015 will be enrolled.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

236 participants in 1 patient group

Group 1

Description:

According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection

Treatment:

Drug: Aflibercept (EYLEA, BAY-86-5321)