The Study of Drug 601 in Patients With Diabetic Macular Edema (DME)

Inclusion Criteria:

• Sign informed consent form and willing to be visited at the time specified in thetrial

• Age >= 18 years and age =< 75 years

• Diagnosis of type 1 or type 2 diabetes

• Hemoglobin (HbA1c) value =< 11%

• The study eye must meet the following criteria

• Diabetic macular edema with central fovea involvement and visual impairment insubjects;

• Best corrected visual acuity letter score (ETDRS)>= 19 (i.e., 20/400 or better)and <= 73 (i.e., 20/40 or worse)in the study eye;

• CRT ≥ 275 μm;

• No optometric media opacity and pupil shrinkage.

• Best corrected visual acuity letter score (ETDRS) > =24 (i.e., 20/320 or better)in thefellow eyes

Exclusion Criteria:

• Any eye has active ocular infections (e.g.,blepharitis, keratitis, scleritis,conjunctivitis);

• The study eye has proliferative diabetic retinopathy (PDR), except for the PDR withregression after panretinal photocoagulation, and Inactive, fibrotic PDR

• History of vitreous hemorrhage in the study eye within 2 months before screening

• Structural retinal damage with fovea in the study eye (e.g. retinal pigmentepithelium(RPE) atrophy, retinal fibrosis, laser scarring, dense hard exudation), orresearchers believe that the study eye has other retinal damage that may hinder visualimprovement after macular edema subsides

• In addition to diabetic retinopathy, there are other causes of macular edema or visualchanges in the study eye. Ophthalmic conditions (e.g.,retinal vein occlusion (RVO) Choroidal neovascularization,retinal detachment, macular hole, retinal traction in macular region, epiretinal membrane,etc.)

• Iris neovascularization in the study eye;

• Uncontrollable glaucoma in the study eye (defined as intraocular pressure afterantiglaucoma medication>= 25 mm Hg), or glaucoma filtering surgery history;

• Researchers believe that cataract in the study eye may affect the judgement ofexamination or test results, or surgical treatment is required in 6 months followingscreening

• The study eye has no lens( except intraocular lens)

• History of Intraocular injection for corticosteroids (e.g. triamcinolone) at any timein the past 3 months, or corticosteroids injection around the eyes within one monthbefore screening

• History of vitrectomy in the studyeye

• History of panretinal photocoagulation in the study eye in the past 6 months beforescreening; or panretinal photocoagulation may be required following screening

• Study eye have received more than two local/grid retinal photocoagulation treatments,or history of local/grid retinal photocoagulation treatments in the study eye in thepast 3 months before screening

• History of anti-VEGF drugs treatments(e.g. Abercept, Pigatani Sodium, Razumab,Bevacizumab, etc.) in any eye or system within 3 months before screening;

• History of any intraocular surgery (e.g. cataract surgery, YAG posterior capsulotomy,etc) in the study eye within 3 months before screening;

• History of ophthalmic surgery involving macular areas (e.g. PDT, maculartransposition) in the study eye, except for local/grid retinal photocoagulation Any of the following general condition are present:

• Uncontrolled blood pressure control (defined as systolic blood pressure > 150 mmHg ordiastolic pressure > 95 mmHg after antihypertensive medication

• The subjects is suffering from systemic infections and requiring oral, intramuscularor intravenous medication

• History of stroke, transient ischemic attack, myocardial infarction or acutecongestive heart failure in the past 6 months before screening;

• Medicines with toxicity to the lens, retina or optic nerve (deferoxamine,chloroquine,hydroxychloroquine (chloroquine), tamoxifen and phenol etc.) is being usedor may be used during the study period

• Diagnosed systemic immune diseases (e.g. ankylosing spondylitis and systemic lupuserythematosus etc.), or any uncontrolled clinical problem (e.g. AIDS, malignanttumors, active hepatitis, serious mental, neurological, cardiovascular, respiratoryand other systemic diseases, etc.)

• History of allergy to fluorescein sodium and allergies to protein products fortreatment or diagnosis, history of allergy to more than two drugs and/or non-drugfactors, or suffering from allergic diseases now Any of the following laboratory tests abnormalities:

• Diabetic patients with uncontrolled blood glucose (fasting blood glucose >= 8.8mmol/L);

• Renal function impairment (Cr is 1.5 times higher than the upper limit of normalvalues in the local laboratory) Liver dysfunction (ALT or AST is 2 times higher thanthe upper limit of normal value in the local laboratory).

• Abnormal coagulation function (prothrombin time >= the upper limit of normal value for 3 seconds) and activated partial thromboplastin time >= the upper limit of normalvalue for 10 seconds) Patients with childbearing age with any of the following conditions:

• Those who do not use effective contraceptive measures; The following are not excluded:

1. Natural amenorrhea for more than 12 months, or natural amenorrhea for 6 months and theserum follicle-stimulating hormone level > 40 mIU/mL;

2. Bilateral ovariectomy with/without hysterectomy for more than 6 weeks;

3. Use acceptable contraceptive methods(Sterilization, hormone contraception,Intrauterinedevice, double barrier method)

4. Be able to use reliable contraceptives throughout the study period and stick to theend of the visit, (Unacceptable contraceptive methods include regular abstinence bycalendar, ovulation, body temperature measurement, post-ovulation and fertilization invitro);

• Pregnancy and lactation women (pregnancy is defined as urinary pregnancy testpositive in this study)

• Participation in any other drug clinical trials (except vitamins and minerals) inthe past 1 month before screening

• Researchers think it needs to be ruled out.