Zhuochuming®-3T&E-DME Study (Treatment-naïve Patients)

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.