* CRTH258A2303E1 - Extension study to CRTH258A2303 (TALON)
Research type
Research Study
Full title
A 56-week phase IIIb/IV, open-label, one-arm extension study to assess the efficacy and safety of brolucizumab 6mg in a Treat-to-Control regimen with maximum treatment intervals up to 20 weeks for the treatment of patients with neovascular Age-related Macular Degeneration who have completed the CRTH258A2303 (TALON) study
IRAS ID
290516
Contact name
Robin Hamilton
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-002349-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 7 days
Research summary
The purpose of this study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control regimen for treatment of patients with neovascular age-related macular degeneration with the objective to assess the potential for long durability up to 20 weeks.
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 patients who have completed the CRTH258A2303 TALON study, approximately 622 patients will be enrolled in approximately 200 centres worldwide. All patients will receive brolucizumab.
REC name
London - Westminster Research Ethics Committee
REC reference
21/FT/0047
Date of REC Opinion
19 Apr 2021
REC opinion
Favourable Opinion