Faricimab for previously-treated eyes with neovascular age-related macular degeneration with inadequate response – 6-month interim analysis of the FURGGHORN study
Long T. Phan , Jennifer Chin , Geoffrey K. Broadhead , Thomas H. Hong , Hemal Mehta , John H. Chang , Samantha Fraser-Bell , Chui Ming Gemmy Cheung , Christopher Ziyu Sun , Alan P. Luckie , Sanjeewa S. Wickremasinghe , Gerald Liew , Jagjit S. Gilhotra , Matthew P. Simunovic , Nitin Verma , Andrew A. Chang
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引用次数: 0
Abstract
Purpose
To investigate the effect of switching to faricimab therapy patients with neovascular age-related macular degeneration currently treated with anti-VEGF therapy.
Design
Phase IV, prospective, single-arm, open-label, multi-center, investigator-initiated clinical trial.
Methods
Eligible eyes received four initial doses of faricimab 6 mg/0.05 mL every 4-weeks. From week 12, dosing intervals were increased to eight weeks and then modified according to a treat-and-extend based regimen. This interim analysis reports changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), retinal fluid proportions, and the incidence of adverse events from baseline through to week 24.
Results
One-hundred-and-two patients of mean age 76.0 years were recruited from 12 sites across Australia and Singapore. Baseline BCVA was 72 Early Treatment Diabetic Retinopathy Study letters and baseline CST was 384 µm. Seventy-two percent of eyes were being treated with aflibercept 2 mg and 28% with ranibizumab. After switching to faricimab, mean BCVA change was + 1.9 letters at week 12 (P < 0.001), and + 1.9 letters at week 24 (P < 0.001). Mean CST change was −83.9 µm at week 12 (P < 0.001), and −82.2 µm at week 24 (P < 0.001). The proportion of eyes with fluid resolution was 54% at week 12, and 59% at week 24. The proportion of eyes assigned to 4-weekly, 8-weekly, and 12-weekly treatment intervals were 16%, 35% and 49% respectively at week 24. Anterior chamber inflammation occurred in one eye with no cases of vasculitis or occlusive retinitis.
Conclusions
In this pre-specified interim analysis of a prospective study, patients switching to faricimab experienced improved anatomic outcomes and maintained visual function, with a large proportion assigned extended dosing intervals under a flexible treatment regimen.
期刊介绍:
The Asia-Pacific Journal of Ophthalmology, a bimonthly, peer-reviewed online scientific publication, is an official publication of the Asia-Pacific Academy of Ophthalmology (APAO), a supranational organization which is committed to research, training, learning, publication and knowledge and skill transfers in ophthalmology and visual sciences. The Asia-Pacific Journal of Ophthalmology welcomes review articles on currently hot topics, original, previously unpublished manuscripts describing clinical investigations, clinical observations and clinically relevant laboratory investigations, as well as .perspectives containing personal viewpoints on topics with broad interests. Editorials are published by invitation only. Case reports are generally not considered. The Asia-Pacific Journal of Ophthalmology covers 16 subspecialties and is freely circulated among individual members of the APAO’s member societies, which amounts to a potential readership of over 50,000.