Journal article
Tolerating Subretinal Fluid in Neovascular Age-Related Macular Degeneration Treated with Ranibizumab Using a Treat-and-Extend Regimen FLUID Study 24-Month Results
Robyn H Guymer, Caroline M Markey, Ian L McAllister, Mark C Gillies, Alex P Hunyor, Jennifer J Arnold
OPHTHALMOLOGY | ELSEVIER SCIENCE INC | Published : 2019
Abstract
PURPOSE: To test the hypothesis that tolerating some subretinal fluid (SRF) in patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab using a treat-and-extend (T&E) regimen can achieve similar visual acuity (VA) outcomes as treatment aimed at resolving all SRF. DESIGN: Multicenter, randomized, 24-month, phase 4, single-masked, noninferiority clinical trial. PARTICIPANTS: Participants with treatment-naïve active subfoveal choroidal neovascularization (CNV). METHODS: Participants were randomized to receive ranibizumab 0.5 mg monthly until either complete resolution of SRF and intraretinal fluid (IRF; intensive arm: SRF intolerant) or resolution of all IRF on..
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Funding Acknowledgements
The FLUID study was funded by Novartis Pharmaceuticals Australia Pty. Ltd. The sponsor participated in the design of the study; conducting the study; data management; data analysis; and preparation, review, and approval of the manuscript.