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

NCT07612904 | Not Yet Recruiting Phase 4

• 1 other identifier: QL-RE1-25002
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Prospective; randomized controlled; open-label; multicenter

Outcome Measures

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

  Week52

Secondary Outcomes (5)

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

  Week 52

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

  Week 52

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

  Week 52

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

  Week 52

• To compare the incidence and severity of adverse events (AE) and serious adverse events (SAE) during the treatment period between the experimental group and the control group

  From week 0 to week 52, plus a 30-day safety follow-up after the last dose

Study Arms (2)

3+T&E Regimen

EXPERIMENTAL

Biological: Aflibercept Intravitreous Injection

3+PRN Regimen

ACTIVE COMPARATOR

Biological: Aflibercept Intravitreous Injection

Interventions

Aflibercept Intravitreous Injection BIOLOGICAL

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.

3+PRN Regimen; 3+T&E Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose and must use an acceptable method of contraception.
• Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.
• The study eye has center-involving diabetic macular edema (DME), defined as central retinal thickness (CRT) ≥300 μm (or ≥320 μm assessed by Heidelberg Spectralis) confirmed by the reading center of the Third People's Hospital of Dalian (primary center) at baseline visit. The reading center is composed of three senior vitreoretinal specialists and experts from the functional examination department of the Third People's Hospital of Dalian.
• Visual impairment is primarily caused by DME.

You may not qualify if:

• 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.
• Prior photodynamic therapy in the study eye.
• Active ocular inflammation (including trace or more) in either eye.
• Aphakia or absence of the posterior capsule in the study eye (excluding pseudophakic eyes).
• History of corneal transplantation in the study eye.
• History of idiopathic or autoimmune uveitis in either eye.
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>25 mmHg despite anti-glaucoma medication) or history of glaucoma filtering surgery.
• Any history of vitreous hemorrhage in the study eye within 4 weeks prior to screening.
• Presence of other retinal diseases in the study eye, such as retinal detachment, retinal vein occlusion, etc.
• Inadequately controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg based on average of ≥2 measurements), allowing improvement with antihypertensive treatment; or history of hypertensive crisis or hypertensive encephalopathy.
• Severe cardiovascular disease (myocardial infarction or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months prior to the first dose.
• Renal failure requiring dialysis or kidney transplantation.

Sponsors & Collaborators

• The Third Peoples Hospital of Dalian: lead
• Qilu Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The Third Peoples Hospital of Dalian

Dalian, Liaoning, 1160033, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)