The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
234
IBI302(dose 1) intravitreal injection given as protocol
IBI302(dose 2) intravitreal injection given as protocol
IBI302(dose 3) intravitreal injection given as protocol
Peking University People's Hospital
Beijing, Beijing Municipality, China
Incidence and severity of ocular and non-ocular adverse events.
To evaluate the number of subjects with ocular and non-ocular adverse events, treatment emergent adverse event, adverse event of special interest, serious adverse events; number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
Time frame: Up to week 20
DLT in each group
Time frame: 7 days
Change of BCVA from baseline by visit
Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: through study completion,an average of 20 weeks
Change of CST from baseline by visit
Central subfield thickness(CST) was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading.
Time frame: through study completion,an average of 20 weeks
Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)
Time frame: through study completion,an average of 20 weeks
The ADA and neutralizing antibody
Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to IBI302 by a validated enzyme-linked immunosorbent assay (ELISA).
Time frame: through study completion,an average of 20 weeks
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Aflibercept intravitreal injection given as protocol