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Completed

NCT Number: NCT02321241

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

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

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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept (EYLEA, BAY-86-5321)

Drug
  • 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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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..

  2. Proportion of patients with less than 15 letters loss

    Time frame: Between initial visit and up to 1 year maximum

  3. Proportion of patients with dry-OCT

    Time frame: Between initial visit and up to 1 year maximum

  4. Mean duration of treatment with ranibizumab before initiation of aflibercept

    Time frame: Between initial visit and up to 1 year maximum

  5. Mean change in Central retinal thickness in µm (OCT)

    Time frame: Between initial visit and up to 1 year maximum

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: TITAN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2014
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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