Observational Post-Authorisation Study of Oxervate® (Cenegermin 20 µg/ml) eye drops in the treatment of adult patients with moderate or severe Neurotrophic Keratopathy. (DEV0118)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45907
• EU PAS number:
  EUPAS32335
• Study ID:
  45907
• Official title and acronym:
  Observational Post-Authorisation Study of Oxervate® (Cenegermin 20 µg/ml) eye drops in the treatment of adult patients with moderate or severe Neurotrophic Keratopathy. (DEV0118)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Oxervate® was approved for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratopathy in adults by European Medicines Agency in 2017. The objective of this study is to describe treatment patterns for adult patients receiving Oxervate® for the cure of moderate or severe Neurotrophic Keratopathy to give insight on the utilization of this topical treatment in real-world clinical practice rather than strict conditions imposed by a formal clinical trial. This long-term product registry aims to consolidate existing data sources on patients diagnosed with moderate or severe Neurotrophic Keratopathy exposed to Oxervate® in qualified ophthalmological centers from participating countries in EU.
• Study status:
  Finalised

Research institution and networks

Institutions

Multiple centres: 7 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 30/09/2018

Study start date

Actual: 17/06/2019

Date of final study report

Planned: 31/12/2021

Actual: 06/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Dompé farmaceutici S.p.A.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable