Clinical Study of the Safety and Efficacy of BAT5906 Injection

Inclusion Criteria:

• Only the following criteria are met:

1. Sign the informed consent voluntarily, willing and capable to follow theprocedures of outpatient visits and research at the time specified in the trial
2. Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years old;
3. The drug treatment to control diabetes must be stable within 3 months beforerandomization and is expected to remain stable during the study period;
4. Macular edema secondary to diabetes, and found to be involved in the macularcenter (fovea) of the research eye by OCT examination, confirmed by the readingcenter during screening;
5. The CRT of the research eye evaluated by OCT examination is ≥300 μM, confirmed bythe reading center during screening;
6. The BCVA of the research eye is 73-24 letters (using the ETDRS table, includingthe boundary value, which is equivalent to the Snellen visual acuity score of theresearch eye equal to 20/40 -20/400);
7. Contralateral eye BCVA ≥ 34 letters (using ETDRS table, equivalent to snellenvision ≥ 20/200). Note: If both eyes meet the inclusion criteria, the eye withpoor baseline vision is selected as the research eye;
8. At the time of screening and baseline, the investigator judged that thecontralateral eye was expected to not require any anti-VEGF treatment within 3months (PK group only).

Exclusion Criteria:

• If a patient meets any of the following conditions, they cannot enter the study: Eye exclusion criteria:

1. There is structural damage to the center of the macula in the eye, and the bestcorrected vision may not be improved after the macular edema resolves, includingatrophy of retinal pigment epithelial cells, subretinal fibrosis or scarring, andobvious macular ischemia (FFA suggests arching Obvious damage), macular anteriormembrane involving fovea or organic hard exudate (as confirmed by the reading centerbefore randomization);
2. The research eye has iris lesions and neovascular glaucoma;
3. Those who have no eye lens (except intraocular lens);
4. The study eye has active hyperplastic diabetic retinopathy (PDR);
5. The research eye has anyone other than diabetic macular edema that may confuse macularassessment or vision testing (retinal vascular occlusion, retinal detachment, vitreousmacular traction, macular hole, preretinal fibrosis involving the macula, choroidalneovascularization, age Related macular degeneration, etc.);
6. The research eye is accompanied by poorly controlled glaucoma, which is defined as theintraocular pressure still ≥21mmHg after treatment with anti-glaucoma drugs, oraccording to the judgment of the investigator;
7. The research eye has undergone or may have undergone anti-glaucoma surgery during thestudy period (including trabeculectomy, sclerectomy and non-penetrating trabecularsurgery, etc.);
8. The research eye has undergone vitreoretinal surgery or scleral buckling;
9. At the time of screening and baseline, the study eye had received laserphotocoagulation (total retina or macular laser photocoagulation) within 90 days (including 90 days) or during the study period;
10. At the time of screening and baseline, the study eye had any intraocular or perocularsurgery within 90 days (including 90 days) (except for yttrium-aluminum-garnet (YAG)lens capsule incision and eyelid surgery for more than 30 days) ;
11. A history of uveitis in any eye;
12. Any eye has active ocular inflammation or infection (bacterial, viral, parasitic orfungal infection);
13. At the time of screening and baseline, any eye had received intraocular anti-VEGFtreatment within the first 90 days (including 90 days), such as ranibizumab,bevacizumab, abercept, compacept, etc.;
14. At the time of screening and baseline, any eye has received intraocular, periocular,and subconjunctival corticosteroid treatment within the first 90 days (including 90days); Exclusion criteria for abnormal conditions in laboratory inspection:
15. Abnormal liver and kidney function (this test specifies that ALT and AST should not behigher than the upper limit of the normal value of the laboratory in the center by 2.5times; Crea and BUN should not be higher than the upper limit of the normal value ofthe laboratory in the center by 2 times);
16. Abnormal blood coagulation function (prothrombin time ≥ upper limit of normal value 3seconds, activated partial thromboplastin time ≥ upper limit of normal value 10seconds);
17. Any one of the infected patients: active hepatitis B (if HBsAg(+) requires HBV DNAmust be> 500 IU/mL or the hospital maximum limit), hepatitis C, AIDS or syphilis (positive RPR test); Other exclusion criteria:
18. Myocardial infarction or stroke occurred within 6 months before the first dose;
19. Poorly controlled diabetes [defined as glycated hemoglobin (HbA1c)>9%)];
20. Accompanied by uncontrollable hypertension (defined as blood pressure >150/100 mmHgafter treatment with antihypertensive drugs);
21. Patients who took large doses of oral or injectable corticosteroids and other hormonaldrugs (>10 mg prednisolone or the same dose/day) within 6 months before screening, butpatients who used steroid drugs for inhalation, nasal cavity or local skin small dosesexcept;
22. Those who have undergone surgery within 1 month and have not healed, or according tothe investigator's judgment;
23. There is a history of contraindications to the study drug, metabolic dysfunction,physical examination results, or a disease or symptom that is reasonably suspected ofbeing based on clinical laboratory results is a contraindication to the study drug,which may affect the judgment of the study results, or make the subject suffer Higherrisk of complications;
24. Allergy or contraindications to known research drugs or their ingredients, fluoresceinor povidone iodine;
25. Those who participated in clinical trials of any drugs (except vitamins and minerals)or devices 90 days before the first dose (including 90 days);
26. Women who are pregnant, pregnant or breastfeeding (pregnancy is defined as a positiveblood/urine pregnancy test in this trial); male or female subjects of fertility do notagree to the entire study period and within 3 months after the end of the visit periodTake appropriate contraceptive measures (such as IUD, birth control pills or condoms,etc.). For women who have not been menopausal or have been menopausal but have not metthe menopause time continuously for more than 12 months, and have not undergonesterilization surgery (ovarian and/or hysterectomy), they are defined as havingfertility. The definition of fertility may be adjusted according to local standards ineach region. Note: High-efficiency contraception methods include total abstinence, IUD, doublebarrier method (eg condom + diaphragm with spermicides, implanted contraceptives,hormonal contraceptives [contraceptives, implanted contraceptives, transdermalPatches, hormone-vaginal devices or sustained-release injections], or the partner hasundergone a vasectomy and is confirmed to have no sperm);
27. The researchers believe that there are other conditions that need to be excluded.