Diabetic Macular Edema
Conditions
Interventions
Patients receive faricimab treatment:None
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Signed the informed consent form and age >= 18 years at time of signing the informed consent form; 2.Naïve or refractory patients diagnosed with DME; 3.The central retinal thickness (CRT) of the diseased eye was greater than 300 µm; 4.Patients decide to receive faricimab treatment and use UWFFA prior to first intravitreal injection (IVT) of faricimab;
Exclusion criteria
Exclusion criteria: 1.Patients were unable to provide UWFFA result prior to receiving the first injection of faricimab; 2.Poor retinal images quality due to severe cataract or vitreous hemorrhage; 3.Patients with high-risk of proliferative diabetic retinopathy (PDR), including: (1). Any vitreous or preretinal hemorrhage ;(2). Neovascularization >= 1/2 disc area at other sites equivalent to the area within 7 fields of ETDR after standard mydriasis in clinical examination or CFP examination ;(3). Optic disc neovascularization >= 1/3 disc area in clinical examination; 4.Patients undergoing panretinal photocoagulation; 5.Patients have received macular (focal, grid, or micropulse) laser; 6.Presence of traction retinal detachment, preretinal fibrosis, vitreomacular traction, or epiretinal membrane (grade III-IV) involving the fovea or disrupting macular structure in the study eye; 7.Any intravitreal steroid within 6 months (180 days) prior to the first injection of faricimab in the study eye; 8.Active ocular inflammation or suspected/active ocular infection in either eye; 9.Concurrent active systemic infection; 10.Previous history of vitrectomy in the study eye; 11.Patients with systemic concomitant medications (e.g., steroid, anti-VEGF drugs) or other potentially retinotoxic drugs; 12.Patients concurrently participating in other ophthalmic clinical trials within 28 days prior to enrollment; 13.Other conditions that the investigator considers inappropriate for the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Panretinal Leakage Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average changes of Li in different retinal regions from baseline;Best Corrected Visual Acuity;Mean change of leakage area in different retinal regions from baseline;Mean change from baseline in central subfield thickness (CST), intraretinal fluid (IRF), and subretinal fluid (SRF);Changes in weekly cell morphology measured by AOLSO compared to baseline;Study the number of IVT procedures for the eye;Durvalumab treatment interval; | — |
Countries
China
Contacts
Public ContactZhaoyang Wang
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed