check_circleStudy Completed

Diabetic Retinopathy

Bayer Identifier:

18636

ClinicalTrials.gov Identifier:

NCT02924311

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Man or woman aged 18 years or older
    - Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation).
    - Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study
    - Patient diagnosed with type 1 or 2 diabetes mellitus
    - Patient who has been given appropriate information about the study and who has given his/her written, informed consent
  • - Patient with other retinal disease at the time of inclusion
    - Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept
    - Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor)
    - Patient taking part in an interventional study

Trial summary

Enrollment Goal
402
Trial Dates
September 2016 - December 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 patients
    date_rangeTime Frame:
    At baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population
    date_rangeTime Frame:
    At baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups
    date_rangeTime Frame:
    At baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups
    date_rangeTime Frame:
    At baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups
    date_rangeTime Frame:
    At baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Type of the previous treatment(s) in previously treated patients
    i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Duration (months) of the previous treatment in previously treated patients
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Date of the last administered treatment in previously treated patients
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Reason for starting intravitreal aflibercept
    i.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 optimized
    date_rangeTime Frame:
    At baseline, 12 months and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of eyes injected
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits with injection
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Interval (days) between injections
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Type of adjunctive therapy post IVT aflibercept initiation
    i.e: surgery, focal laser, steroids, etc
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups
    date_rangeTime Frame:
    At baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups
    date_rangeTime Frame:
    At baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up
    date_rangeTime Frame:
    At baseline, 12 months and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in HbA1c level during macular disease monitoring
    HbA1c: Glycated haemoglobin A1c
    date_rangeTime Frame:
    At baseline, 12 months and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in blood pressure during macular disease monitoring
    date_rangeTime Frame:
    At baseline, 12 months and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of the disease (DME Monitoring)
    date_rangeTime Frame:
    At baseline
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits for monitoring only (DME Monitoring)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits for injection only (DME Monitoring)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits combining monitoring and injection (DME Monitoring)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 center
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits with OCT assessments (DME monitoring)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits with fundus photography assessments (DME monitoring)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits with fluorescein angiography assessments (DME monitoring)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits with visual acuity measurements (DME monitoring)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with ocular and non-ocular safety events
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A prospective observational study conducted in France to describe routine clinical practice for treatment naïve or previously treated patients with diabetic macular edema (DME) who are starting IVT aflibercept
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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