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

ConditionDiabetic Macular Edema (DME)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Third Peoples Hospital of Dalian

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject voluntarily participates in the study and signs the informed consent form.

Subject is aged ≥18 years and has a diagnosis of type 1 or type 2 diabetes mellitus.

Refractive status and axial length of the study eye: -6.00D < spherical equivalent < +6.00D, or 21 mm < axial length < 26 mm.

Best-corrected visual acuity (BCVA) of the study eye at screening and baseline is between 78 and 24 ETDRS letters (approximately equivalent to Snellen 20/32 to 20/320).

Disqualifiers

Known hypersensitivity to any component of the study drug.

Prior intraocular surgery in the study eye, including macular laser photocoagulation, panretinal photocoagulation, etc.

Prior intraocular or periocular steroid treatment in the study eye.

Prior intravitreal anti-VEGF therapy (e.g., ranibizumab, conbercept, bevacizumab) in the study eye.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aflibercept Intravitreous Injection

    Biological/Vaccine

    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.

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: 3+T&E RegimenExperimental treatment 1 intervention
Group B: 3+PRN RegimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To compare the change from baseline in best-corrected visual acuity (BCVA) at week 52 between the experimental group and the control group

Time frame
Week52

Secondary outcomes

1

Compare the change from baseline in OCT-measured central retinal thickness at week 52 between the experimental and control groups

Time frame
Week 52
2

Compare the proportion of patients achieving a ≥15-letter gain in BCVA from baseline at week 52 between the experimental and control groups

Time frame
Week 52
3

Compare the proportion of patients with a <15-letter loss in BCVA from baseline at week 52 between the experimental and control groups

Time frame
Week 52
4

To compare the number of injections within 52 weeks between the experimental group and the control group

Time frame
Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Third Peoples Hospital of Dalian

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: