The trial will assess the asset in patients with diabetic macular oedema. Credit: NTshutterth / Shutterstock.

MSD (Merck & Co) and its wholly-owned subsidiary EyeBio have announced the start of the Phase IIb/III BRUNELLO clinical trial of Restoret (MK-3000, formerly known as EYE103) for treating diabetic macular oedema (DME).

The randomised, double-masked trial will assess the efficacy and safety of two different dose levels of intravitreal (IVT) Restoret compared to the active control, ranibizumab, in DME patients.

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Participants will be randomised in a 1:1:1 ratio to receive either a low or high dose of MK-3000 or ranibizumab every four weeks during the initial year of the trial.

Treatment frequency will be adjusted using a personalised treatment interval (PTI) algorithm in the second year.

Safety and the mean change in best-corrected visual acuity (BCVA) from baseline to week 52 in the study eye, measured using standardised Early Treatment of Diabetic Retinopathy Study (ETDRS) vision are the trial’s dual primary endpoints.

This trial commencement builds upon the results from the Phase I/II AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD).

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MK-3000 is an investigational tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) signalling pathway.

It is administered via intravitreal injection and aims to address unmet medical needs in retinal diseases, including DME and NVAMD, by reducing vascular leakage and restoring the blood-retinal barrier.

In preclinical studies, the asset activated the Wnt pathway in the retina to help reduce vascular leakage.

EyeBio founder, CEO and president Dr David Guyer said: “Data from the Phase I/II AMARONE study provided early evidence for the potential of MK-3000 for patients with retinal disease.

“The initiation of the BRUNELLO trial marks an important milestone as we work with our new colleagues at Merck, driven by the common purpose to deliver new, much-needed options for patients with diabetic macular oedema.”