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

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.