Starting soon
Phase 4
Zhuochuming®-3T&E-DME Study (Treatment-naïve Patients)
Condition(s) studied
Diabetic Macular Edema (DME)
Investigational drug(s) / intervention(s)
Aflibercept Intravitreous Injection
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.
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.
Eligibility
Inclusion Criteria:
1. Subject voluntarily participates in the study and signs the informed consent form.
2. Subject is aged ≥18 years and has a diagnosis of type 1 or type 2 diabetes mellitus.
3. Refractive status and axial length of the study eye: -6.00D \< spherical equivalent \< +6.00D, or 21 mm \< axial length \< 26 mm.
4. 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).
5. 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.
6. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.
7. 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.
8. Visual impairment is primarily caused by DME.
Exclusion Criteria:
1. Known hypersensitivity to any component of the study drug.
2. Prior intraocular surgery in the study eye, including macular laser photocoagulation, panretinal photocoagulation, etc.
3. Prior intraocular or periocular steroid treatment in the study eye.
4. Prior intravitreal anti-VEGF therapy (e.g., ranibizumab, conbercept, bevacizumab) in the study eye.
5. Prior photodynamic therapy in the study eye.
6. Active ocular inflammation (including trace or more) in either eye.
7. Aphakia or absence of the posterior capsule in the study eye (excluding pseudophakic eyes).
8. History of corneal transplantation in the study eye.
9. History of idiopathic or autoimmune uveitis in either eye.
10. Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>25 mmHg despite anti-glaucoma medication) or history of glaucoma filtering surgery.
11. Any history of vitreous hemorrhage in the study eye within 4 weeks prior to screening.
12. Presence of other retinal diseases in the study eye, such as retinal detachment, retinal vein occlusion, etc.
13. 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.
14. Severe cardiovascular disease (myocardial infarction or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months prior to the first dose.
15. Renal failure requiring dialysis or kidney transplantation.
16. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
17. History of schizophrenia or substance abuse (psychoactive drugs).
18. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.
19. Glycated hemoglobin (HbA1c) level ≥10%, and/or recent signs of uncontrolled diabetes (≥3 episodes of severe hypoglycemia within 3 months before baseline, or hospitalization due to acute hyperglycemia-related complications such as diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or other emergencies caused by severe hyperglycemia (e.g., dehydration, electrolyte disturbance, altered consciousness); or ≥2 episodes of DKA within 1 year before baseline, or ≥1 episode of DKA within 3 months before baseline).
20. Presence of proliferative diabetic retinopathy (PDR) in the study eye.
21. Ocular disease in the study eye that may confound interpretation of study results, including choroidal neovascularization (CNV) of any cause (e.g., age-related macular degeneration, ocular histoplasmosis, or pathologic myopia).
22. Cataract in the study eye that causes visual impairment, or patients judged by the investigator as likely to undergo cataract surgery during the study period.
23. The study eye is aphakic (post-vitrectomy), silicone oil-filled, or gas-filled.
24. Best-corrected visual acuity (BCVA) of the non-study eye \<19 ETDRS letters (approximately equivalent to Snellen 20/400) at screening and baseline.
25. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
Primary outcome measure(s)
- To compare the change from baseline in best-corrected visual acuity (BCVA) at week 52 between the experimental group and the control group — Week52
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The Third Peoples Hospital of Dalian |
Dalian |
Liaoning |
|
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