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

NCT07612904 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Macular Edema (DME)

Interventions

BIOLOGICAL

Aflibercept Intravitreous Injection

Experimental：Intravitreal aflibercept 2 mg/0.05 mL (Zhuochuming®), 3 monthly loading doses (W0, W4, W8). From W12: treat-and-extend (T\&E) regimen. Interval extension (by 2-4 weeks, max 16 weeks) if no intraretinal/subretinal fluid on OCT and no worsening criteria. Interval maintenance if fluid persists but decreases. Interval shortening (by 2-4 weeks, min 6 weeks) if new/recurrent fluid, or BCVA loss ≥5 letters with recurrent fluid, or increase in central retinal thickness ≥100 μm. Active Comparator：Intravitreal aflibercept 2 mg/0.05 mL (Zhuochuming®), 3 monthly loading doses (W0, W4, W8). From W12: pro re nata (PRN) regimen with assessments every 4 weeks. Re-injection criteria: central retinal thickness \>250 μm, or increase \>50 μm from previous lowest OCT, or loss of ≥5 ETDRS letters in BCVA accompanied by an increase in CRT.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • The Third Peoples Hospital of Dalian

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612904 on ClinicalTrials.gov