Evaluation of IBI302 Injection in nAMD or DME

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Jul 17, 2023

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Eligibility criteria

• • Inclusion criteria
• • 1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol;
• • 2. Male or female patiensubjects ≥ 18 yrs. of age;
• • 3. For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
• • 4. For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;
• • 5. BCVA ETDRS letter score of 24-73 in the study eye;
• • Exclusion criteria
• • 1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
• • 2. Presence of uncontrolled glaucoma in the study eye ;
• • 3. Presence of active intraocular or periocular inflammation or infection;
• 4. Prior any treatment of following in the study eye:
• • 1. Anti-VEGF therapy or anti-complement therapy;
• • 2. Laser photocoagulation;
• • 3. History of vitreoretinal surgery;
• • 4. Glucocorticoid treatment(intravitreal or peribulbar) ;
• • 5. BCVA score \<19 letters in the fellow eye;
• • 6. Anti-VEGF therapy in the fellow eye within 30 days of day 0;
• • 7. Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) or malignant tumor;
• • 8. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
• • 9. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
• • 10. Participated in any clinical study of any other drug within 90 days of day 0, or attempted to participate in other drug trials during the study;
• • 11. Other conditions unsuitable for enrollment judged by investigatiors.