NCT02321241

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

12 months

First QC Date

December 17, 2014

Last Update Submit

June 29, 2018

Conditions

Wet Macular Degeneration

Keywords

Wet-AMDRefractory patients to ranibizumabReal lifeSwitchAflibercept

Outcome Measures

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))

    The 12 month follow up visit is the visit 12 month after the first injection of aflibercept

    Between initial visit and 12 month follow up visit

Secondary Outcomes (5)

  • Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters

    Between initial visit and up to 1 year maximum

  • Proportion of patients with less than 15 letters loss

    Between initial visit and up to 1 year maximum

  • Proportion of patients with dry-OCT

    Between initial visit and up to 1 year maximum

  • Mean duration of treatment with ranibizumab before initiation of aflibercept

    Between initial visit and up to 1 year maximum

  • Mean change in Central retinal thickness in µm (OCT)

    Between initial visit and up to 1 year maximum

Study Arms (1)

Group 1

According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection

Drug: Aflibercept (EYLEA, BAY-86-5321)

Interventions

Aflibercept (EYLEA, BAY-86-5321)DRUG

1. st year: 3 monthly injections followed by 1 injection every two months 2. nd year and following: injection according the visual and anatomical results observed the 1st year

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of wAMD refractory to ranibizumab (persistence of fluid) who started a treatment with Anti VEGF (Aflibercept) may be included in the study

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, France

Location

Related Publications (1)

  • Razavi S, Kodjikian L, Giocanti-Auregan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6.

    PMID: 33596867DERIVED

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

February 1, 2016

Primary Completion

January 18, 2017

Study Completion

August 18, 2017

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

FR(1)