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:

NCT02924311

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
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Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Completed

Trial Design