Clinical trial NCT02321241: Real Life of Aflibercept in France in Patients Refractory to Ranibizumab: Observational Study in Wet AMD
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Macular Degeneration
Keywords: Wet-AMD
Refractory patients to ranibizumab
Real life
Switch
Aflibercept
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-12-22
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of wAMD refractory to ranibizumab (persistence of fluid) who started a treatment with Anti VEGF (Aflibercept) may be included in the study

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.

Eligibility 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

Primary outcomes:
measure: Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm))
timeFrame: Between initial visit and 12 month follow up visit
Secondary outcomes:
measure: Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters
timeFrame: Between initial visit and up to 1 year maximum
measure: Proportion of patients with less than 15 letters loss
timeFrame: Between initial visit and up to 1 year maximum
measure: Proportion of patients with dry-OCT
timeFrame: Between initial visit and up to 1 year maximum
measure: Mean duration of treatment with ranibizumab before initiation of aflibercept
timeFrame: Between initial visit and up to 1 year maximum
measure: Mean change in Central retinal thickness in µm (OCT)
timeFrame: Between initial visit and up to 1 year maximum
Other outcomes:
Locations:
city: Multiple Locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Razavi S, Kodjikian L, Giocanti-Auregan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6.