Trial Condition(s):

Wet Macular Degeneration

Real life of Aflibercept in France in patients refractory to Ranibizumab: observational study in Wet AMD (TITAN)

Bayer Identifier:

17405

ClinicalTrials.gov Identifier:

NCT02321241

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
236
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

many locations, France

Status
Active, not recruiting
 

Trial Design