check_circleStudy Completed
Diabetic Retinopathy
Bayer Identifier:
18636
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Routine clinical practice for use of intravitreal aflibercept treatment in patients with diabetic macular edema
Trial purpose
The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).
This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.
This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
402Trial Dates
September 2016 - December 2019Phase
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, France |
Primary Outcome
- Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patientsdate_rangeTime Frame:At baseline and 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study populationdate_rangeTime Frame:At baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groupsdate_rangeTime Frame:At baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groupsdate_rangeTime Frame:At baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groupsdate_rangeTime Frame:At baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Type of the previous treatment(s) in previously treated patientsi.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroidsdate_rangeTime Frame:At baselineenhanced_encryptionNoSafety Issue:
- Duration (months) of the previous treatment in previously treated patientsdate_rangeTime Frame:At baselineenhanced_encryptionNoSafety Issue:
- Date of the last administered treatment in previously treated patientsdate_rangeTime Frame:At baselineenhanced_encryptionNoSafety Issue:
- Reason for starting intravitreal aflibercepti.e: clinically significant macular edema conducting to a decrease of visual acuity, early care of DME, laser photocoagulation or vitrectomy not indicated, diabetes care not optimizeddate_rangeTime Frame:At baseline, 12 months and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of eyes injecteddate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits with injectiondate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Interval (days) between injectionsdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Type of adjunctive therapy post IVT aflibercept initiationi.e: surgery, focal laser, steroids, etcdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groupsdate_rangeTime Frame:At baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groupsdate_rangeTime Frame:At baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-update_rangeTime Frame:At baseline, 12 months and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change in HbA1c level during macular disease monitoringHbA1c: Glycated haemoglobin A1cdate_rangeTime Frame:At baseline, 12 months and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change in blood pressure during macular disease monitoringdate_rangeTime Frame:At baseline, 12 months and 24 monthsenhanced_encryptionNoSafety Issue:
- Duration of the disease (DME Monitoring)date_rangeTime Frame:At baselineenhanced_encryptionNoSafety Issue:
- Number of visits for monitoring only (DME Monitoring)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits for injection only (DME Monitoring)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits combining monitoring and injection (DME Monitoring)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of monitoring visits for diabetes (by diabetologists, general practitioners) outside the study center over 12 and 24 months (if known by the ophthalmologist) (DME monitoring)Monitoring visits for diabetes by diabetologists or general practitioners outside the study centerdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits with OCT assessments (DME monitoring)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits with fundus photography assessments (DME monitoring)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits with fluorescein angiography assessments (DME monitoring)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits with visual acuity measurements (DME monitoring)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Number of participants with ocular and non-ocular safety eventsdate_rangeTime Frame:Up to 24 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A