Evaluation of IBI302 Injection in nAMD or DME
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration
Eligibility Criteria
Inclusion criteria Willing and able to sign informed consent form and comply with visit and study procedures per protocol; Male or female patiensubjects ≥ 18 yrs. of age; For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD; 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; BCVA ETDRS letter score of 24-73 in the study eye; Exclusion criteria Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results; Presence of uncontrolled glaucoma in the study eye ; Presence of active intraocular or periocular inflammation or infection; Prior any treatment of following in the study eye: Anti-VEGF therapy or anti-complement therapy; Laser photocoagulation; History of vitreoretinal surgery; Glucocorticoid treatment(intravitreal or peribulbar) ; BCVA score <19 letters in the fellow eye; Anti-VEGF therapy in the fellow eye within 30 days of day 0; 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; 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 90 days of day 0, or attempted to participate in other drug trials during the study; Other conditions unsuitable for enrollment judged by investigatiors.
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Aflibercept
IBI302
only phase II