A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration

Inclusion criteria

• Male or female patient ≥ 50 yrs. of age.
• Active subfoveal CNV secondary to wet AMD, with lesion size ≤ 12 optic discs in the study eye.
• BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.
• Central macular sub-field thickness according to OCT of at least 250 micron.
• Clear stereoscopic fundus photography is obtained while the lens or other media is clear.
• 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.
• Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

• Presence of other causes of CNV other than wet AMD in the study eye.
• Presence of active diabetic retinopathy in the study eye.
• Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
• Prior retinal detachment in the study eye.
• Prior any treatment of following in the study eye:

• Anti-VEGF therapy within 6 months prior to screening;
• Anti-complement therapy;
• Laser photocoagulation;
• Photodynamic therapy;
• Transpupillary thermotherapy
• Intraocular surgery;
• Intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment;
• Presence of any non-AMD disease that may affect visual acuity in the study eye
• Prior anti-VEGF therapy within 1 month before study drug administration or plan of above anti-VEGF therapy in the non-study eye during the whole study.
• Oral steroid drugs within 1 month before study drug administration.
• Presence of active intraocular or periocular inflammation or infection.
• Diabetic patients have any of the following conditions:

• Microvascular and macrovascular complications;
• HbA1c>7.5% when screening;
• Receiving more than two oral hypoglycemic agents;
• Receiving insulin or GLP-1 receptor agonist;
• Hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard treatment);
• Presence of any following laboratory abnormality:

• PLT<100×109/L, INR≥1.5ULN, APTT≥ 10 seconds more than ULN;
• ALT or AST >2ULN;
• Cr or Ur>1.5ULN;
• Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.