Wet Macular Degeneration
Conditions
Keywords
Wet-AMD, Refractory patients to ranibizumab, Real life, Switch, Aflibercept
Brief 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
Detailed 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.
Interventions
DRUGAflibercept (EYLEA, BAY-86-5321)
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
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm)) | Between initial visit and 12 month follow up visit | The 12 month follow up visit is the visit 12 month after the first injection of aflibercept |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters | Between initial visit and up to 1 year maximum | 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.. |
| 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 | — |
Countries
France
Outcome results
None listed