DeFineDR - Observational Study

• Research type

  Research Study

• Full title

  A clinical trial collecting data from routine ophthalmological examinations of patients who were randomised to either finerenone or placebo in the two Bayer sponsored phase 3 clinical trials FIDELIO and FIGARO to investigate the effect of Finerenone on delaying the progression of Diabetic Retinopathy

• IRAS ID

  291427

• Contact name

  Kieran McCafferty

• Contact email

  kieran.mccafferty4@nhs.net

• Sponsor organisation

  Bayer Plc

• Eudract number

  2020-003865-20

• Clinicaltrials.gov Identifier

  NCT04795726

• Duration of Study in the UK

  0 years, 4 months, 28 days

• Research summary

  The purpose of this study is to investigate the effect of Finerenone on delaying the progression of diabetic retinopathy in participants in the phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD by collecting information from their routine
  eye health screening assessments.

  Diabetic eye health screening is routine standard of care offered once per year to patients with diabetes who is 12 years old or over.

  Therefore, no formal study visits are arranged and the data will be retrospectively collected from consenting patients' medical notes. There will be no change in treatment and apart from provision of consent participating patients will not
  be required to have additional clinical procedures as a part of this study.

  Participation in this study starts when the patient has signed informed consent and ends after the last data point has been collected and entered into eCRF by the investigator. Once the patient's eye health screening data has been
  collected their participation will be complete.

  There is no treatment duration as this is an observational study, however study duration will depend on the individual duration of the participation in FIDELIO-DKD (16244) and FIGARO-DKD (17530) study.

  For every available routine ophthalmological examination, the investigator will enter the data into an electronic data capture form. The amount of data collected for each patient will depend on the time of follow up in phase 3 trial and the
  frequency of examinations during that time.

  Only data from examinations that took place up to 6 months prior to the patients baseline visit in FIDELIO-DKD or FIGARO-DKD until the end of participation in FIDELIO-DKD or FIGARO-DKD trials will be requested.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  20/SC/0446

• Date of REC Opinion

  22 Dec 2020

• REC opinion

  Favourable Opinion