CRTH258A2303: Brolucizumab 6 mg vs aflibercept 2 mg in nAMD (TALON)
Research type
Research Study
Full title
CRTH258A2303: A 64-week, two-arm, randomized, double-masked, multicenter, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with neovascular age related macular degeneration (TALON)
IRAS ID
263251
Contact name
Robin Hamilton
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2019-000716-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 24 days
Research summary
The purpose of this study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control (TtC) regimen for the treatment of patients with neovascular age-related macular degeneration (nAMD) with the objective to evaluate the potential to reduce treatment frequencies
Neovascular AMD (nAMD) is characterized by the growth of abnormal new blood vessels (neovascularization) under the retinal pigment epithelium (RPE) or sub-retinal space from the subjacent choroid, termed choroidal neovascularization (CNV) (Ferris et al 1984). These newly formed vessels have an increased likelihood to leak blood and serum, damaging the retina by stimulating inflammation and scar tissue formation. This damage to the retina results in progressive, severe, and irreversible vision loss
Vascular endothelial growth factor (VEGF) has been shown to be elevated in patients with nAMD and is thought to play a key role in the neovascularization process.
The use of intravitreal injection (IVT) pharmacotherapy targeting VEGF has significantly improved visual outcomes in patients with nAMD.Anti-VEGF treatments, such as ranibizumab (Lucentis®) and aflibercept (Eylea®), inhibit VEGF signaling pathways and have been shown to halt the growth of neovascular lesions and resolve retinal edema. Intravitreal administration of anti-VEGF treatments is the current standard of care in nAMD. They have considerably reduced the incidence of blindness and severe vision loss and revolutionized outcomes for patients with nAMD.
The study population will be male and female patients ≥ 50 years old diagnosed with active choroidal neovascularization (CNV) secondary to AMD, not treated previously for this disease and able to comply with study or follow-up procedures.
Approximately 692 patients will be randomized in a 1:1 ratio in approximately 200 centers worldwide.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0293
Date of REC Opinion
26 Sep 2019
REC opinion
Favourable Opinion