TALON clinical trial: Efficacy and safety of brolacizumab in the treatment of exudative AMD 26/11/2019

IF YOU WANT TO PARTICIPATE IN A CLINICAL TRIAL, SEND US YOUR DATA HERE AND WE WILL EVALUATE IF YOU ARE ELEGIBLE

Description

Multicentre, randomised double-blind Phase IIIb study to evaluate the efficacy and safety of brolacizumab 6mg compared to aflibercept 2mg in a treatment regimen until control in patients with the exudative form of age-related macular degeneration (AMD).

Main inclusion criteria

Patients of 50 and above with an active choroidal neovascularisation secondary to AMD and who have not received any previous treatment in the study eye.

Visual acuity should be between 38 and 83 letters (approximate Snellen equivalent of 20/25 to 20/200).

Aims

To evaluate the efficacy and safety of brolacizumab in comparison with aflibercept with regard to the results for visual acuity at 28 and 32 weeks in reference to the baseline, but also in terms of the duration of the intervals between treatments.

About the drug

Vascular endothelial growth factor (VEGF) is a glycoprotein with a trophic and proliferative role, promoting the growth of new filtering and abnormal blood vessels in the retina in patients with exudative AMD.

Brolacizumab (RTH258) is a humanised single-chain antibody fragment (scFv) that is responsible for blocking the action of VEFG-A, preventing it from binding to its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, meaning that its principal function is anti-angiogenic. Brolacizumab is designed for ophthalmic use and administered by intravitreal injection.

Previous studies have produced results that support the commencing of a Phase IIIb trial in order to evaluate the safety and efficacy of brolacizumab in patients with neovascular AMD, with the aim of prolonging the therapeutic effect and enabling improved penetration of retinal tissue.

Duration

The duration of this trial is sixteen months.

* Institut Registration Code: E08607500. Clinica trial n. EudraCT 2019-000716-28. Clinical trial authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the CEIm of the Quironsalud Hospital Group in Barcelona.

IF YOU WANT TO PARTICIPATE IN A CLINICAL TRIAL, SEND US YOUR DATA HERE AND WE EVALUATE IF YOU ELEGIBLE