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 (APOLLON)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (S01LA05) aflibercept

  aflibercept
• Medical condition to be studied:
  Diabetic retinopathy

Population studied

• Short description of the study population:
  The study population will consist of patients with diabetic macular edema (DME) who have not been treated with aflibercept ever, and initiating treatment with IVT aflibercept per the ophthalmologist ‘s discretion. The prescription of the medicines is clearly separated from the decision to include the patient in the study. Patients population will be divided in two subgroups :  Treatment naïve patient : 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 Previously treated patient : 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 Female and male patients with a diagnosis of DME will be enrolled after the decision for treatment with IVT aflibercept has been made by the investigator. If patient receiving bilateral treatment, eye with the worst visual acuity at baseline will be considered as study eye.; Inclusion criteria; 1. Male or female aged 18 years or older; 2. Patient diagnosed with a visual impairment due to DME (as defined by HAS recommendation); 3. Patients in whom a decision to treat with IVT aflibercept has been made independently of the patient enrollment in the study; 4. Patient diagnosed with type 1 or 2 diabetes mellitus; 5. Patient who has been given appropriate information about the study and who has given his/her written, informed consent; Exclusion criteria; 1. Patient with other retinal disease at the time of inclusion; 2. Patients currently being treated with IVT aflibercept. This study will only include patients new to IVT aflibercept.; 3. Systemic use of any anti / pro VEGF therapy; 4. Patient taking part in an interventional study
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetic macular edema patients
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The main objectives of this observational study are to describe effectiveness outcomes, monitoring and treatment patterns of in patients with DME in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population will be evaluated as well as the 2 subgroups (previously treated patients and treatment naïve patients).
• Outcomes:
  Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients, Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study populationMean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groupsMean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups(More secondary outcomes is posted on www.ClinicalTrials.gov)
• Data analysis plan:
  Statistical analyses will be explorative and descriptive only. All processes concerning patient validity, data consistency checks, permissible data modifications will be described in detail in the Data Management Plan. All statistical details including calculated variables and proposed format and content of tables will be detailed in the Statistical Analysis Plan.