The SAFE Study

• Research type

  Research Study

• Full title

  Phase 2a Study of the Effect of Serine Supplementation and Fenofibrate Treatment on Serum Deoxysphinganine Levels in Patients with Macular Telangiectasia (MacTel) Type 2 (SAFE Study)

• IRAS ID

  1005394

• Contact name

  Katie Nardo

• Contact email

  info@lmri.net

• Sponsor organisation

  Lowy Medical Research Institute, Ltd. (LMRI)

• Eudract number

  2021-002874-21

• Clinicaltrials.gov Identifier

  NCT04907084

• Research summary

  Research Summary: Macular telangiectasia type 2 (MacTel), an age-related bilateral degenerative condition of the macula that may cause
  progressive loss of vision, is estimated to have an incidence of 1:2,200 (Aung 2010, Klein 2010, Sallo 2012). Recent
  research by the MacTel Consortium has determined that MacTel patients have low serine levels compared to a
  matched control group, and that low serine is correlated with elevated deoxysphingolipids, which are toxic to neurons
  (Gantner 2019). The purpose of this study is to determine if and to what extent serine supplementation or fenofibrate
  treatment reduces circulating levels of deoxysphingolipids in MacTel patient serum. Fasted serum will be collected
  prior to, during, between and after supplementation/treatment to monitor deoxysphingolipid levels.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  22/SC/0234

• Date of REC Opinion

  9 Nov 2022

• REC opinion

  Further Information Favourable Opinion