Efficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema

Main Inclusion Criteria:

1. Age ≥ 18 years old, gender is not limited;
2. Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%;
3. The visual impairment of the study eye was mainly caused by diabetic macular edema;
4. OCT examination at screening and baseline, diabetic macular edema involving the foveaof the study eye, and central retinal thickness (CRT) ≥ 300 μm (using SD-OCT);
5. The best-corrected visual acuity (BCVA) of the study eye at screening and baselinemeasured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart wasbetween 73 and 24 letters (inclusive) (approximately equivalent to Snellen's visualacuity) score 20/40 to 20/320).

Main Exclusion Criteria:

1. Active proliferative diabetic retinopathy (PDR) exists in the study eye;
2. Structural damage to the fovea in the study eye, which may not improve BCVA afterresolution of macular edema (eg, retinal pigment epithelial cell atrophy, subretinalfibrosis or scarring, significant macular ischemia, or organizing hard exudates) );
3. The study eye has any ocular disease or past medical history other than diabeticmacular edema, and the investigator believes that it may affect the macular assessmentor central vision (such as: cataract, retinal vascular occlusion, retinal detachment,macular traction, macular epiretinal membrane , macular hole, macular hemorrhage,preretinal fibrous proliferation involving the macula, various choroidalneovascularization);
4. The study eye has erythema of the iris, vitreous hemorrhage or traction retinaldetachment;
5. The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHgafter anti-glaucoma drug treatment);
6. The study eye has received or may have received glaucoma filtration surgery (such as:trabeculectomy, sclerectomy and non-penetrating trabecular surgery) during the studyperiod;
7. The study eye has received vitreoretinal surgery in the past;
8. Aphakic (except intraocular lens) in the research eye.