check_circleStudy Completed
wet macular degeneration
Bayer Identifier:
17405
ClinicalTrials.gov Identifier:
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
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
BothAge
18 - N/ATrial summary
Enrollment Goal
236Trial Dates
February 2016 - August 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere 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 afliberceptdate_rangeTime Frame:Between initial visit and 12 month follow up visitenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 lettersThe 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 maximumenhanced_encryptionNoSafety Issue:
- Proportion of patients with less than 15 letters lossdate_rangeTime Frame:Between initial visit and up to 1 year maximumenhanced_encryptionNoSafety Issue:
- Proportion of patients with dry-OCTdate_rangeTime Frame:Between initial visit and up to 1 year maximumenhanced_encryptionNoSafety Issue:
- Mean duration of treatment with ranibizumab before initiation of afliberceptdate_rangeTime Frame:Between initial visit and up to 1 year maximumenhanced_encryptionNoSafety Issue:
- Mean change in Central retinal thickness in µm (OCT)date_rangeTime Frame:Between initial visit and up to 1 year maximumenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A