OZDRY
Research type
Research Study
Full title
A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed versus PRN dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in patients with refractory diabetic macular oedema.
IRAS ID
113840
Contact name
Sobha Sivaprasad
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Eudract number
2012-003661-17
ISRCTN Number
n/a
Research summary
Diabetic macular oedema (DMO) is the most common cause of moderate visual loss in people with diabetes. It is characterised by leakage of fluid from unhealthy retinal blood vessels in the macula or the centre of the retina. There are 240,000 patients with sight threatening DMO in the UK and 48,000 new patients are diagnosed with this condition every year. The standard of care for these patients is laser treatment. Only 50% respond to repeated laser treatment. So there is a substantial need for a treatment for macular oedema. Recently, multiple repeated antiVEGF injections have been shown to improve vision in eyes with DMO. However, antiVEGF injection has proven to be labour intensive and expensive, resulting in expansion of resources to hospitals. Hence, it is imperative to develop a drug delivery system that can be administered to provide a sustained release of steroid in this condition.Ozurdex is a long acting steroid implant that is given as an injection into the eye and last up to 6 months. However, the exact dosing frequency is unclear. NICE has approved it for macular oedema due to vein occlusion on the basis that the patients are seen regularly and injected if a decline of vision is recorded. However, this involves a number of hospital visits. The company advocates 5 monthly dosing based on extensive analysis of their Phase 3 trials but it is unclear whether this dosing frequency will provide maximal efficacy. So this study is designed to evaluate the differences in visual outcome and safety profile at 12 months between the two different dosing frequencies of 5 monthly dosing and 'as and when necessary' dosing of Ozurdex on 100 patients using standard tests used in clinical practice.
REC name
London - Harrow Research Ethics Committee
REC reference
12/LO/1534
Date of REC Opinion
9 Nov 2012
REC opinion
Further Information Favourable Opinion