Data from a new study shows that ranibizumab (Lucentis®) used in a treat-and-extend (T&E) regimen cuts clinic visits by 46% for patients with Diabetic Macular Oedema (DMO) - one of the leading causes of visual impairment in the UK - when compared to a PRN regimen of the same drug.1

A range of different treatment strategies are currently used by clinicians in the treatment of DMO. This first prospective study for T&E in DMO published in the British Journal of Ophthalmology1 concludes that ranibizumab used in a T&E regimen has the potential to offer a lower treatment burden for some patients by reducing the number of clinic visits and allowing for a more efficient treatment pathway.

The study findings also highlight that T&E is a non-inferior regimen to PRN based on the mean average change in best-corrected visual acuity (BCVA) from months 1 through 12, with both trial groups showing similar results at month 12, maintained out to month 24. In the T&E arms, over 70% of patients maintained their BVCA with treatment intervals of >2 months over 24 months.

The study confirmed the well characterised safety profile of ranibizumab with reported adverse events being similar to those already reported in its Summary of Product Characteristics.

DMO is a complication of diabetes and is a leading cause of visual impairment among the working-age population.2 Diabetes and diabetic-related diseases are a growing burden on the NHS, with over £1.5m being spent by the NHS on diabetes every hour.3 With more than 80,000 people in the UK living with DMO and this number increasing with diabetes prevalence, it is expected to be a significant public health problem for the foreseeable future.4,5

At the same time, the pressure on eye clinics has been highlighted by organisations such as the RNIB.6

"With concerns about the increasing prevalence of diabetes in the UK, this study showing how one of the most common causes of visual impairment associated with the disease, may be more efficiently managed should be welcomed," said Dr Dimitrios Georgiopoulos, Chief Scientific Officer, Novartis UK. "By ensuring treatments are adapted to a patient's needs, it may be possible to improve the efficiency of clinics.

"The ranibizumab license includes details for administration of a T&E regimen and gives ophthalmologists greater flexibility and means they can now extend treatment or monitoring intervals once maximum visual acuity is achieved and/or there are no signs of disease activity."

About the analysis

Objective: To demonstrate noninferiority of ranibizumab T&E with/without laser to ranibizumab PRN for change in BCVA in patients with DMO.

Methods: A 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on retreatment in the PRN, and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to Month 1-12 (primary), mean BCVA change from baseline to Months 12 and 24, treatment exposure and safety profile.

About DMO

Diabetic Macular Oedema (DMO) is a complication of diabetes that affects the macula, a part of the retina at the back of the eye. The macula is the part of the retina that is responsible for seeing what is right in front of the eye and so is vital for reading, seeing colours properly and recognising faces. DMO is a serious eye condition brought about by the leaking of fluid from the small blood vessels in the eye. The build-up of fluid causes swelling and thickening at the macula in the centre of the eye, reducing vision.7,8

About PRN and Treat & Extend

The pro re nata (PRN) approach is where patients are observed monthly and treated if there are signs of disease growth. Treat-and-extend (T&E) is a treatment method that allows incremental increases in treatment intervals (depending on patient need) with the aim to identify the longest possible treatment and visit free interval.1