Optimization of individualized faricimab dosing for patients with diabetic macular edema: Protocol for the SWAN open-label, single-arm clinical trial.

Purpose: In patients with diabetic macular edema (DME) from YOSEMITE/RHINE, dual angiopoietin-2/vascular endothelial growth factor-A (VEGF-A) inhibition with faricimab resulted in visual/anatomic improvements with extended dosing. The SWAN trial (jRCTs031230213) will assess the efficacy, durability, and safety of faricimab during the treatment maintenance phase in patients with DME using a treat-and-extend (T&E)-based regimen adapted to clinical practice and the characteristics of patients achieving extended dosing intervals.
Methods: SWAN is a 2-year, open-label, single-arm, interventional, multicenter trial enrolling adults with center-involving DME. All patients will receive three initial faricimab 6.0 mg doses every 4 weeks (Q4W). From week 12 onwards, in patients without active DME, dosing intervals will be extended in 8-week increments up to Q24W. In contrast, patients with active DME (central subfield thickness [CST] >325 μm and intraretinal fluid [IRF] or subretinal fluid [SRF] resulting in vision loss/disease aggravation) will receive a dose within a day and the dosing interval will be shortened by 4 weeks to a minimum of Q8W relative to the previous dosing interval. Recruitment commenced in August 2023 across a planned 16 sites in Japan.
Results: The primary endpoint is change in best-corrected visual acuity (BCVA) from baseline at 1 year (averaged over weeks 52, 56, and 60). Key secondary endpoints include: change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire scores over time; proportion of patients with BCVA (decimal visual acuity) ≥0.5, ≥0.7, ≥1.0, or ≤0.1; proportion of patients with absence of DME, and IRF and/or SRF over time. Safety endpoints include incidence/severity of ocular/nonocular adverse events.
Conclusions: The SWAN trial is expected to provide evidence to support individualized faricimab dosing regimens, with the potential to reduce the burden of frequent treatments on patients, caregivers, and healthcare systems.
Competing Interests: Takao Hirano: Speaker Fees: Bayer, Canon, Chugai Pharmaceutical Co., Ltd., Kowa, Novartis Pharma KK, Santen Pharmaceutical Co., Senju, ZEISS Toshinori Murata: Speaker Fees: Bayer, Novartis, Santen, Zeiss Meditec: Consultant: Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd., Hoya, Kowa, Wakamoto Shintaro Nakao: Consultant: Alcon, Boehringer Ingelheim, Novartis, Riverfield; Speaker Fees: Bayer, Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd., Hoya, Kowa, Machida, Mitsubishi Tanabe, Novartis, Novo Nordisk, Otsuka, Santen, Senju, Wakamoto Masahiko Shimura: Consultant: Bayer, Boehringer Ingelheim, Chugai, HOYA, Nikki HD, Roche, Wakamoto; Lecture Fees: Bayer, Chugai, Kowa, Novartis, Otsuka, Senju Miho Nozaki: Speaker Fees: Bayer, Canon, Chugai Pharmaceutical Co., Ltd., Kowa, Nikon, Novartis Pharma KK, Santen, Senju, Sumitomo Pharma Co., Ltd., Topcon Medical, Wakamoto Kiyoshi Suzuma: Speaker Fees: AMO, Alcon, Bayer, Chugai Pharmaceutical Co., Ltd., HOYA, Kowa, Novartis, Senju Consultant: Senju, Chugai Pharmaceutical Co., Ltd., Boehringer Ingelheim Taiji Nagaoka: Consultant: Boehringer Ingelheim, Novartis, TES Holdings; Speaker Fees: Bayer, Chugai Pharmaceutical Co., Ltd., Hoya, Kowa, Mitsubishi Tanabe, Novartis, Santen, Senju, Wakamoto; Research Fees: Daicel, Kowa, LTT, Santen Masahiko Sugimoto: Research Fees: Alcon Japan, Bayer, Chugai Pharmaceutical Co., Ltd., Novartis; Speaker Fees: Alcon Japan, Bayer, Kowa, Novartis, Senju, Wakamoto Yoshihiro Takamura: Lecture Fees: Chugai Pharmaceutical Co., Ltd. Tomoaki Murakami: Speaker Fees: Bayer, Canon, Chugai Pharmaceutical Co., Ltd., Johnson & Johnson, Kowa, Novartis Pharma KK, Santen; Consultant: Boehringer Ingelheim Keisuke Iwasaki: Employee: Chugai Pharmaceutical Co., Ltd. Jun Tsujimura: Employee: Chugai Pharmaceutical Co., Ltd. Shigeo Yoshida: Consultant: Chugai Pharmaceutical Co., Ltd., Novartis; Speaker Fees: Bayer, Chugai Pharmaceutical Co., Ltd., Novartis, Senju; Research Fees: Kowa, Otsuka, Senju We confirm that the author competing interests do not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2024 Hirano et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)