INITIATE - An observational study of DME patients initiated with DEX-I

• Research type

  Research Study

• Full title

  A Multi-country, Post Marketing Observational Study of DME Patients with Suboptimal Response to anti-VEGF who are initiated with Dexamethasone intravitreal implant (DEX-I)

• IRAS ID

  331181

• Contact name

  Luke Nicholson

• Contact email

  luke.nicholson3@nhs.net

• Sponsor organisation

  AbbVie

• Duration of Study in the UK

  2 years, 6 months, 31 days

• Research summary

  Diabetic macular oedema (DME) is a diabetic eye disease where blood vessels leak fluid into the back of the eye, eventually causing blindness. Treatment of DME has changed over the years. Currently, the most common treatment is anti-VEGF that is given to patients as monthly injections into the eye. A different treatment for DME is a steroid drug called dexamethasone (DEX). Instead of injections, patients receive an implant in the eye called dexamethasone intravitreal implant (DEX-I) which slowly releases the drug over time. Studies have shown that DEX is effective at treating DME and may be better than anti-VEGF injections for many patients. However, we don’t know much about the patients who receive DEX-I after they have had anti-VEGF injections.

  This study aims to collect this information so we can understand how to most effectively use DEX-I.
  The study aims to describe the treatment patterns and characteristics of patients before they start taking DEX-I and the impact of when DEX-I treatment is started (i.e. early - after 3 injections of anti-VEGF, or later – after more than 3 injections of anti-VEGF).

  This study will collect data from patients in multiple hospitals and will have two parts. First, information will be collected about patients’ medical history and any previous treatments they received a year before starting DEX-I treatments. Then, after DEX-I treatment starts, information will be collected about the patients’ DME for the next 12 to 18 months. The study aims to collect data on around 80 adult patients with DME who had at least three anti-VEGF injections but did not have a good result and so were then prescribed DEX-I treatment. Information that cannot reveal the patient’s identity will be collected, and this will be anonymised in the final database.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  23/PR/0827

• Date of REC Opinion

  28 Sep 2023

• REC opinion

  Further Information Favourable Opinion