check_circleStudy 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
  • - 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
  • - 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
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
many locationsmany 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
    date_rangeTime Frame:
    Between initial visit and 12 month follow up visit
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    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..
    date_rangeTime Frame:
    Between initial visit and up to 1 year maximum
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients with less than 15 letters loss
    date_rangeTime Frame:
    Between initial visit and up to 1 year maximum
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients with dry-OCT
    date_rangeTime Frame:
    Between initial visit and up to 1 year maximum
    enhanced_encryption
    Safety Issue:
    No
  • Mean duration of treatment with ranibizumab before initiation of aflibercept
    date_rangeTime Frame:
    Between initial visit and up to 1 year maximum
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in Central retinal thickness in µm (OCT)
    date_rangeTime Frame:
    Between initial visit and up to 1 year maximum
    enhanced_encryption
    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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