2.6. Evaluation Criteria
PDR, ocular adverse, peripheral lesions
ADVERSE EVENTS, SECONDARY, LEAKAGE
The primary endpoint was the mean percent change in ischemic index at each assessment point compared with baseline. The secondary endpoints were: (i) fraction of the participants who progressed to PDR, (ii) DME-related changes compared with baseline, (iii) changes in the thickness of cerebrospinal fluid (CSF) and the retinal volume, (iv) visual acuity, (v) improvement and deterioration of the eye compared with baseline, (vi) vascular leakage, and (vii) changes in severity and frequency of peripheral lesions compared with baseline measured at each assessment time point.Safety endpoints included: (i) incidence and characteristics of adverse events after study drug administration; (ii) incidence and characteristics of ocular adverse events; and (iii) physical examination, vital signs, electrocardiogram, and clinical laboratory examination findings related to the administration of the investigational drug.