Real Life of Aflibercept in France in Patients Refractory to Ranibizumab: Observational Study in Wet AMD (TITAN)
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|ClinicalTrials.gov Identifier: NCT02321241|
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : July 2, 2018
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
|Condition or disease||Intervention/treatment|
|Wet Macular Degeneration||Drug: Aflibercept (EYLEA, BAY-86-5321)|
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.
|Study Type :||Observational|
|Actual Enrollment :||236 participants|
|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|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||January 18, 2017|
|Actual Study Completion Date :||August 18, 2017|
According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection
Drug: Aflibercept (EYLEA, BAY-86-5321)
- Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm)) [ Time Frame: 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
- Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters [ Time Frame: 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 [ Time Frame: Between initial visit and up to 1 year maximum ]
- Proportion of patients with dry-OCT [ Time Frame: Between initial visit and up to 1 year maximum ]
- Mean duration of treatment with ranibizumab before initiation of aflibercept [ Time Frame: Between initial visit and up to 1 year maximum ]
- Mean change in Central retinal thickness in µm (OCT) [ Time Frame: Between initial visit and up to 1 year maximum ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321241
|Multiple Locations, France|
|Study Director:||Bayer Study Director||Bayer|