3.3.2. Secondary Efficacy Outcomes
PDR, AMD, edema, dilated venous beading, superonasal microvascular abnormalities
PROGRESSION, EDEMA, LEAKAGE, CLINICALLY SIGNIFICANT MACULAR EDEMA
Progression to PDR (ETDRS severity ≥61) was not observed. Changes in DME degree (without AMD, nonclinically significant macular edema): (i) most changes were not observed from baseline; (ii) 2 of 6 eyes (33.33%) assessed as SMD at baseline improved to grade ‘no SMD’ after treatment (V8 and V9); (iii) none of the eyes had a worse edema degree; (iv) no significant changes in CSF thickness and retinal volume were observed between time points before and after drug administration; and (v) no significant changes in best-corrected ETDRS visual acuity were observed compared with baseline.Changes in DRSS scores from baseline: (i) no eye improved 1 or 2 steps; (ii) one eye was categorized as deterioration of 1 or 2 steps; and (iii) no eye had ≥3 steps (improvement or deterioration).Change in vascular leakage rate from baseline: The average leakage index decreased significantly over time (Greenhouse–Geisser F = 6.442, Changes in the severity and frequency of peripheral lesions: (i) retinal hemorrhage/retinal microvascularization: ‘no change’ in severity in 18 eyes (90.00%), ‘best’ in 2 eyes (10.00%), and no changes in the distribution; (ii) venous beading: ‘no change’ in severity compared with baseline for all V9 visits (100.00%), one eye each with dilated venous beading with intraretinal and superonasal microvascular abnormalities; and (iii) severity: ‘unchanged’ in 18 eyes (90.00%), ‘best’ in 2 eyes (10.00%), and no changes in the distribution.