The goal of this clinical trial is to understand whether Zhuochuming® (Aflibercept Intravitreal Injection) using a 3 loading doses followed by a treat-and-extend regimen (3+T\&E) can treat patients with diabetic macular edema (DME) who have not received prior treatment. It will also evaluate the safety of Zhuochuming®. The main questions it aims to answer are: Can Zhuochuming® using the 3+T\&E regimen improve patients' vision better than the traditional pro re nata (3+PRN) regimen? How much can the macular edema (central retinal thickness) be reduced? What medical problems (ocular or systemic) will participants experience while taking Zhuochuming®? What is the difference in the number of injections needed over one year between the two regimens? Researchers will directly compare Zhuochuming® (3+T\&E regimen) with Zhuochuming® (3+PRN regimen) to see which regimen is more effective and convenient for treating DME. Participants will: Receive treatment and be followed for 52 weeks (about 1 year) First receive 3 injections (one every 4 weeks), and then continue according to their assigned group: T\&E group: Injection intervals are gradually extended (up to 16 weeks) based on disease stability PRN group: Follow-up visits every 4 weeks, with injections given only when needed Visit the clinic at scheduled times (e.g., before each injection or every 4 weeks) for eye examinations (visual acuity, intraocular pressure, OCT, etc.) Undergo regular blood tests (complete blood count, liver function, coagulation function, HbA1c, etc.) Record any discomfort or side effects and report them to the doctor Study population: Patients with diabetic macular edema (DME) who have not received prior treatment, aged ≥18 years, and diagnosed with type 1 or type 2 diabetes. Primary study endpoint: Change in best-corrected visual acuity (BCVA) from baseline at week 52.
Age range
18 Years
Sex
ALL
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To compare the change from baseline in best-corrected visual acuity (BCVA) at week 52 between the experimental group and the control group
Timeframe: Week52