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

Wet Macular Degeneration Clinical Trial

— TITAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321241
• Other study ID #: 17405
• Secondary ID: EY1413FR
• Status: Completed
• Start date: February 1, 2016
• Est. completion date: August 18, 2017

Study information

• Verified date: June 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 18, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of patients with less than 15 letters loss		Between initial visit and up to 1 year maximum
Secondary	Proportion of patients with dry-OCT		Between initial visit and up to 1 year maximum
Secondary	Mean duration of treatment with ranibizumab before initiation of aflibercept		Between initial visit and up to 1 year maximum
Secondary	Mean change in Central retinal thickness in µm (OCT)		Between initial visit and up to 1 year maximum

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