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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A retrospecTive and Prospective Non-Interventional Study to Assess the Clinical pracTice in Real Life for Patients With Wet AMD Refractory to raNibizumab and Switching to Aflibercept

Conditions
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Wet Macular Degeneration

Intervention / Treatment
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* Drug: Aflibercept (EYLEA, BAY-86-5321)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection | Drug: Aflibercept (EYLEA, BAY-86-5321)<br>* st year: 3 monthly injections followed by 1 injection every two months nd year and following: injection according the visual and anatomical results observed the 1st year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm)) | The 12 month follow up visit is the visit 12 month after the first injection of aflibercept | Between initial visit and 12 month follow up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters | The end of study visit is the visit 12 month after the first injection of aflibercept or after last follow up visit when the patient drop out the study whichever apply.. | Between initial visit and up to 1 year maximum | 
| Proportion of patients with less than 15 letters loss |  | Between initial visit and up to 1 year maximum | 
| Proportion of patients with dry-OCT |  | Between initial visit and up to 1 year maximum | 
| Mean duration of treatment with ranibizumab before initiation of aflibercept |  | Between initial visit and up to 1 year maximum | 
| Mean change in Central retinal thickness in µm (OCT) |  | Between initial visit and up to 1 year maximum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aflibercept, Wet-AMD, Refractory patients to ranibizumab, Real life, Switch