SWAN trial eligibility criteria.

BCVA, best-corrected visual acuity; CFP, color fundus photography; CST, central subfield thickness; DME, diabetic macular edema; IMP, investigational medicinal product; PDR, proliferative diabetic retinopathy; PRP, panretinal photocoagulation; SD-OCT, spectral-domain optical coherence tomography; VEGF, vascular endothelial growth factor; YAG, yttrium-aluminum-garnet. *Postmenarchal women who have not reached postmenopausal status (amenorrhea for at least 12 consecutive months with no cause other than menopause), and are not permanently infertile by surgery (removal of ovaries, fallopian tubes and/or uterus) or other causes as determined by the investigator or co-investigator (e.g., Müllerian duct dysplasia) considered women of childbearing potential. According to this provision, women with unilateral tubal ligation are considered women of childbearing potential. ^†Examples of contraceptive methods with annual failure rates of less than 1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper-added intrauterine devices. The reliability of sexual abstinence should be evaluated with respect to the duration of the clinical research and each patient’s preferences and normal lifestyle. Cyclic abstinence (calendar, ovulation day, symptomatic temperature, postovulation, etc.), and external ejaculation are not adequate contraceptive methods. ^‡Systemic anti-VEGF therapy; systemic drugs known to cause macular edema (fingolimod, tamoxifen); intravitreal administration of anti-VEGF agents (other than faricimab) into study eye; intravitreal, periocular (subtenon), steroid implants, or chronic topical ocular corticosteroids into study eye; photodynamic therapy to study eye; micropulse, and focal or grid photocoagulation in the study eye; vitreous surgery or PRP in the study eye; kallidinogenase (for improvement of symptoms of circulatory disturbance of the retinal choroid); other experimental therapies (except those comprising vitamins and minerals).

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