OZLASE study

• Research type

  Research Study

• Full title

  A Prospective Randomised Controlled Trial of Intravitreal Ozurdex and Macular Laser Therapy versus Macular Laser Therapy only in Diabetic Macular Oedema (OZLASE study)

• IRAS ID

  85694

• Contact name

  Philip Hykin

• Sponsor organisation

  Moorfields Eye Hospital R&D Department

• Eudract number

  2011-003339-74

• ISRCTN Number

  .

• Clinicaltrials.gov Identifier

  .

• Research summary

  Macular oedema is the commonest cause of decreased vision in people with diabetes. Macular laser therapy has remained the mainstay of therapy but results in minimal visual improvements benefits. Recently, multiple repeated anti-VEGF injections in the first year have been shown to improve vision in eyes with DMO. However, antiVEGF injection has proven to be labour intensive and expansive, resulting in expansion of resources to hospitals. Hence, it is imperative to develop a drug delivery system that can be administered at the diagnosis of macular oedema with the ability to provide a sustained release of steroid in this condition. Pharmacokinetic studies show that OZURDEX, an intravitreal dexamethasone posterior segment drug delivery system (DEX-PS-DDS), provides sustained release of dexamethasone for up to 6 months and therefore may be ideal for the early management of DMO. Secondly, other steroid (triamcinolone) is associated with side effects such as cataract and glaucoma while studies on Ozurdex (dexamethsaone) have a far superior safety profile. Lastly, other trials have shown the significant visual gain benefit of Ozudex in eyes with macular oedema secondary to retinal vein occlusions (GENEVA trial) and uveitis (HURON trial). It is expected that Ozurdex will have similar results in recent onset DMO as shown by the maximum response noted in the PLACID trial. It is now crucial to study and compare the outcomes of Ozurdex with laser versus laser only in DMO.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  11/WM/0265

• Date of REC Opinion

  23 Sep 2011

• REC opinion

  Further Information Favourable Opinion