Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously treated patient<br>Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.<br>|
| Naïve patient<br>Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.<br>|
| Entire study population<br>Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients |  | At baseline and 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Macular Edema