diabetic macular edema
Conditions
Interventions
Observation group:None
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, no gender restrictions. 2. Study the diagnosis of diabetic macular edema (DME) lesions using eye examinations. An active lesion is defined as the presence of any of the following conditions in the macular area: (1) Fluid within the retina; (2) Lipid exudation within the retina; (3) Subretinal fluid. 3. DME that affects the fovea and results in a decline in the patient's visual acuity, with a central retinal thickness (CRT) >= 250 µm. 4. The stage is classified as NPDR. 5. The study eye had a BCVA measured using the ETDRS visual acuity chart of 73 to 34 letters (equivalent to a Snellen visual acuity chart range of 20/40 to 20/200 for the study eye). 6. Has received at least 3+ PRN Lucentis biosimilar treatments between January 2023 and June 2026.
Exclusion criteria
Exclusion criteria: 1.Any of the following conditions satisfies the exclusion criteria: Previous medical history/screening period: The affected eye has received any form of treatment within the past 6 weeks, including anti-VEGF medications, glucocorticoids, and laser photocoagulation (full-retinal laser photocoagulation, macular laser photocoagulation). 2. Patients with one eye. 3. Eye infections and other diseases that could affect the results of the study. 4. Situations determined by researchers to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month mean change in BCVA from baseline;adverse event; | — |
Countries
China
Contacts
Public ContactXu Yufeng
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed