Trial Condition(s):
Diabetic Retinopathy
Routine clinical practice for use of intravitreal aflibercept treatment in patients with diabetic macular edema (APOLLON)
Bayer Identifier:
18636
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
3
Primary Outcome
- Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patientsTimeframe: At baseline and 12 months
Secondary Outcome
- Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study populationTimeframe: At baseline and 12 months
- Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groupsTimeframe: At baseline and 24 months
- Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groupsTimeframe: At baseline and 12 months
- Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groupsTimeframe: At baseline and 24 months
- Type of the previous treatment(s) in previously treated patientsi.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroidsTimeframe: At baseline
- Duration (months) of the previous treatment in previously treated patientsTimeframe: At baseline
- Date of the last administered treatment in previously treated patientsTimeframe: At baseline
- 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 optimizedTimeframe: At baseline, 12 months and 24 months
- Number of eyes injectedTimeframe: Up to 24 months
- Number of visits with injectionTimeframe: Up to 24 months
- Interval (days) between injectionsTimeframe: Up to 24 months
- Type of adjunctive therapy post IVT aflibercept initiationi.e: surgery, focal laser, steroids, etcTimeframe: Up to 24 months
- Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groupsTimeframe: At baseline and 24 months
- Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groupsTimeframe: At baseline and 24 months
- Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-upTimeframe: At baseline, 12 months and 24 months
- Mean change in HbA1c level during macular disease monitoringHbA1c: Glycated haemoglobin A1cTimeframe: At baseline, 12 months and 24 months
- Mean change in blood pressure during macular disease monitoringTimeframe: At baseline, 12 months and 24 months
- Duration of the disease (DME Monitoring)Timeframe: At baseline
- Number of visits for monitoring only (DME Monitoring)Timeframe: Up to 24 months
- Number of visits for injection only (DME Monitoring)Timeframe: Up to 24 months
- Number of visits combining monitoring and injection (DME Monitoring)Timeframe: Up to 24 months
- 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 centerTimeframe: Up to 24 months
- Number of visits with OCT assessments (DME monitoring)Timeframe: Up to 24 months
- Number of visits with fundus photography assessments (DME monitoring)Timeframe: Up to 24 months
- Number of visits with fluorescein angiography assessments (DME monitoring)Timeframe: Up to 24 months
- Number of visits with visual acuity measurements (DME monitoring)Timeframe: Up to 24 months
- Number of participants with ocular and non-ocular safety eventsTimeframe: Up to 24 months
Additional Information
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