Study Completed

wet macular degeneration

Bayer Identifier:

17405

ClinicalTrials.gov Identifier:

NCT02321241

EudraCT Number:

Not Available

EU CT Number:

Not Available

Real life of Aflibercept in France in patients refractory to Ranibizumab: observational study in Wet AMD

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

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

236

Trial Dates

February 2016 - August 2017

Phase

Phase 4

Could I Receive a placebo

Products

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	many locations	many locations, France

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 aflibercept
Time Frame:
Between initial visit and 12 month follow up visit
Safety Issue:
No

Secondary Outcome

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..
Time Frame:
Between initial visit and up to 1 year maximum
Safety Issue:
No
Proportion of patients with less than 15 letters loss
Time Frame:
Between initial visit and up to 1 year maximum
Safety Issue:
No
Proportion of patients with dry-OCT
Time Frame:
Between initial visit and up to 1 year maximum
Safety Issue:
No
Mean duration of treatment with ranibizumab before initiation of aflibercept
Time Frame:
Between initial visit and up to 1 year maximum
Safety Issue:
No
Mean change in Central retinal thickness in µm (OCT)
Time Frame:
Between initial visit and up to 1 year maximum
Safety Issue:
No

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

N/A

Additional Information

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