Diabetic Macular Edema
Conditions
Interventions
Faricimab 3+T&E regimen:None
Sponsors
Yuebei People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in this study with signed written informed consent. 2.Aged =18 years old with no gender restriction. 3.Clinically diagnosed with type 1 or type 2 diabetes mellitus. 4.Glycated hemoglobin (HbA1c) =10% during the screening period (tested within 2 months prior to Day 1 visit). 5.Macular thickening secondary to diabetic macular edema (DME) involving the central fovea, with central subfield thickness (CST) =300 µm at screening. 6.One eye is selected as the study eye, which is treatment-naive to anti-VEGF agents. 7.Best-corrected visual acuity (BCVA) ranges from 25 to 73 ETDRS letters (equivalent to approximately 20/320 to 20/40 on Snellen chart). If both eyes are eligible, the eye with worse BCVA shall be chosen as the study eye. 8.Clear refractive media and fully dilated pupils to ensure high-quality imaging acquisition. 9.Agree to maintain abstinence or adopt contraceptive measures with an annual failure rate less than 1% during treatment and for at least 3 months after the last administration (e.g., bilateral tubal ligation, male sterilization, hormonal contraceptives, hormonal intrauterine devices, copper intrauterine devices).
Exclusion criteria
Exclusion criteria: 1.High-risk proliferative diabetic retinopathy (PDR) in the study eye, defined by any of the following: vitreous/preretinal hemorrhage; retinal neovascularization covering =1/2 disc area; optic disc neovascularization covering =1/3 disc area. 2.High-risk proliferative diabetic retinopathy (PDR) in the study eye, defined by any of the following: vitreous/preretinal hemorrhage; retinal neovascularization covering =1/2 disc area; optic disc neovascularization covering =1/3 disc area. 3.Active uveitis or uncontrolled glaucoma. 4.History of retinal detachment or stage 3/4 macular hole. 5.Pregnant or breastfeeding females confirmed before Day 1 of the study. 6.Any prior intravitreal injection of anti-VEGF agents in the study eye before Day 1. 7.History of the following ocular surgeries or treatments: cataract surgery, or steroid therapy/yttrium-aluminum-garnet laser posterior capsulotomy within 3 months prior to Day 1 due to cataract surgery complications; other intraocular surgeries including keratoplasty, glaucoma filtering surgery, pars plana vitrectomy, ocular radiotherapy, etc. 8.Periocular (subconjunctival) corticosteroid treatment within 6 months prior to Day 1 of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity;Central subfield thickness; | — |
Countries
China
Contacts
Public ContactHuang Yaling
Yuebei People’s Hospital
Outcome results
None listed