A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema

Inclusion criteria

• Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
• Male or female subjects with age of 18~80 yrs.
• Diagnosis of diabetes mellitus(type 1 or 2), and current regular use of insulin or other injectable drugs or oral anti-hyperglycaemic agent for the treatment of diabetes.
• Visual impairment was caused by DME involving the macular fovea.
• Central macular sub-field thickness (CST) ≥320μm according to OCT.
• BCVA score of 24-73 letters using ETDRS charts (in 4 meters) in the study eye.
• Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.

Exclusion criteria

• Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
• PDR in the study eye.
• Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye.
• Active rubeosis in the study eye.
• The equivalent spherical lens≤-8.00D in the study eye.
• The intraocular pressure>21 mmHg in the study eye.
• Active ocular or periocular inflammation/infection in either eye.
• Prior any treatment of following in the study eye:

• Intravitreal anti-VEGF treatment within 3 months prior to baseline;
• Intraocular glucocorticoid injection within 3 months prior to baseline;
• PRP, local/grid laser photocoagulation within 3 months prior to baseline;
• Any intraocular surgery (e.g. cataract surgery) within 90 days prior to baseline;
• The eyes were treated with lasik posterior capsulotomy or glaucoma filtration, radiotherapy 30 days before baseline;
• Currently untreated diabetes mellitus or previously untreated DM subjects who initiated oral or injectable antidiabetic medication or insulin <90 days;
• HbA1c of >10% within 28 days prior to baseline;
• Presence of any systemic disease: including but not limited to unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
• History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
• Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
• Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
• Other conditions unsuitable for enrollment judged by investigators