Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02321241
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

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


Condition or disease Intervention/treatment
Wet Macular Degeneration Drug: Aflibercept (EYLEA, BAY-86-5321)

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 236 participants
Observational Model: Cohort
Time Perspective: Other
Official 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
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : January 18, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection
Drug: Aflibercept (EYLEA, BAY-86-5321)
  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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321241


Locations
Layout table for location information
France
Multiple Locations, France
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02321241    
Other Study ID Numbers: 17405
EY1413FR ( Other Identifier: company internal )
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Keywords provided by Bayer:
Wet-AMD
Refractory patients to ranibizumab
Real life
Switch
Aflibercept
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases