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Sunderland Eye Infirmary in the North East and North Cumbria are the top recruiter globally in the Hornbill trial

on a navy background are NIHR design motifs, to the right there is a close up of a pupil from a brown eye

Sunderland Eye Infirmary (SEI), part of South Tyneside and Sunderland NHS Foundation Trust, was one of 6 sites in the UK chosen to deliver the HORNBILL study; a global multi-centre study which additionally involved 14 US sites in total.

SEI have succeeded in screening 15 patients and recruiting 6 participants to the study and became the top recruiters not only nationally, but globally.

HORNBILL is a phase IIa trial in Diabetic Macular Ischaemia (DMI), which is a rare and severe form of diabetic retinopathy, which can lead to permanent and irreversible visual loss. Diabetic Retinopathy and maculopathy are some of the leading causes of blindness in the working age group. There are currently no available treatments for DMI, making it an urgent unmet need which the HORNBILL trial seeks to address.

The HORNBILL study is the first-in human trial funded by Boehringer Ingelheim to bridge the transition from preclinical investigation to a clinical development of a new pharmacological agent (the medicine) that investigates how safe it is and the biological response in volunteer patients with DMI.

The study tests different doses of the trial drug, which are administered to humans for the first time via an injection into the eye. It aims to find out how well the different doses are tolerated in patients who have previously received a laser treatment called panretinal photocoagulation, a procedure which aims to prevent severe vision loss and reduce pain in the eye. The doctors compare the trial drug injections to sham injections, whilst regularly checking the general health of the participants.

Over a period of more than 12 months, the research team at SEI have worked tirelessly in
collaboration with their local Diabetic Eye screening program to identify potentially eligible
patients to invite for the study. When recruitment ended on 25 November 2022, they had six patients randomised.

This is a monumental achievement as the trial was split into two parts; SEI only participated in one half and despite this, still recruited more patients (screenings and randomisations) than any other site who participated in both.

The Principal Investigator, Mr Maged S Habib (MSc Ophth, FRCS, FRCOphth, MD), Consultant Ophthalmologist and Vitreoretinal Surgeon at South Tyneside & Sunderland NHS Foundation Trust, and his entire retinal team have been praised by the sponsor for their tremendous efforts; impressive energy, capability and expertise; motivation to recruit patients quickly; their ingenuity to find different and novel ways in which to identify patients (using AI), and their perseverance with this challenging trial.

The Sunderland Eye Infirmary team are now looking to recruit into another similar Boehringer Ingelheim trial in DMI, and have very high hopes for recruitment into this trial as we begin 2023.

Professor Caroline Wroe, Clinical Director of the NIHR Clinical Research Network North, said:

It is wonderful that one of our Trusts in the region has received such positive feedback. I respect the commitment and dedication from the research teams within our region. Sunderland Eye Infirmary’s performance in this trial is a great example of putting the national emphasis on working effectively with the life sciences industry into action. They are an asset to the Trust and to the region. We look forward to working closely with Boehringer-Ingelheim on future early phase trials.

Maged Habib, Principal Investigator of the new trial, from South Tyneside and Sunderland NHS Foundation Trust said:

We are very proud to have taken part in such an important clinical trial and offer our patients a chance to be exposed to this potentially new beneficial treatment agent that can help reverse the microvascular damage and restore vascularity to the macula and hence improve their vision. It is the essence of the Sunderland Eye Infirmary to remain at the forefront for all new research and innovative developments that can help improve the quality of our clinical care to our patients and provide new treatments to restore and improve their vision.

We believe that research and clinical care service delivery work in conjunction and harmony to ensure our patients have access and can receive all available new effective and safe evidence-based treatment’ modalities.