Trial Condition(s):
Wet Macular Degeneration
Real life of Aflibercept in France in patients refractory to Ranibizumab: observational study in Wet AMD (TITAN)
Bayer Identifier:
17405
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations many locations many locations, France | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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 afliberceptTimeframe: Between initial visit and 12 month follow up visit
Secondary Outcome
- Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 lettersThe 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..Timeframe: Between initial visit and up to 1 year maximum
- Proportion of patients with less than 15 letters lossTimeframe: Between initial visit and up to 1 year maximum
- Proportion of patients with dry-OCTTimeframe: Between initial visit and up to 1 year maximum
- Mean duration of treatment with ranibizumab before initiation of afliberceptTimeframe: Between initial visit and up to 1 year maximum
- Mean change in Central retinal thickness in µm (OCT)Timeframe: Between initial visit and up to 1 year maximum
Additional Information
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