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 identification

• EU PAS number:
  EUPAS15687
• Study ID:
  37890
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The main objectives of this observational study are 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 will be evaluated as well as the two subgroups (previously treated patients and treatment naïve patients). This study is designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 61 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:08/03/2016

Study start date

Planned:30/06/2016

Actual:21/09/2016

Date of final study report

Planned:22/07/2020

Actual:06/07/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)