Thirty eyes per treatment group were required if one assumed a 10% dropout rate. With this sample size,
there is a 20% chance for a failure to detect a true mean difference of at least 50 μm between the treatment groups (type I error), or for an incorrect conclusion that a difference of at least 50 μm exists between the treatment groups (type II error). A total of 48 patients with center-involved DME in at least 1 eye were identified during the study period. Forty-five patients (60 eyes; IV ranibizumab: 28 eyes, IV bevacizumab: 32 eyes) were included in the outcomes analyses; www.selleckchem.com/products/pd-0332991-palbociclib-isethionate.html all patients were included in the safety analyses. The 3 patients excluded from the outcomes analyses consisted of 1 patient in the IV ranibizumab group who developed Staphylococcus aureus endophthalmitis after the first injection (this patient chose to exit the study and he did not complete any further study visits); 1 patient in the IV bevacizumab group who developed advanced posterior subcapsular cataract, which precluded adequate
SDOCT images, after the ninth follow-up visit; and 1 patient from the IV bevacizumab group who missed 3 consecutive follow-up visits. Another patient in the IV ranibizumab group developed Streptococcus mitis endophthalmitis after the 44-week study visit, but he completed all study visits and his data were included in the analysis. One patient in the IV bevacizumab group developed transient inferior vitreous hemorrhage attributable to acute posterior vitreous detachment at week 36
and was also maintained in the analysis. Fifteen patients with bilateral DME received IV ranibizumab in 1 eye and IV bevacizumab selleck products in the other eye, and 30 patients received unilateral treatment. Forty percent of eyes (24/60) had proliferative diabetic retinopathy treated with PRP at least 6 months before the initial evaluation. Mean duration of DME estimated by the patients’ reported duration of decreased vision was 37.3 months and 38.1 months in the IV bevacizumab and IV ranibizumab groups, respectively. The time interval between the last anti-VEGF or steroid treatment and study enrollment was at least 6 months. In the bevacizumab group, the number of eyes that had received IV triamcinolone, bevacizumab, or ranibizumab prior to entering the during current study was 1, 3, and 2 eyes, respectively; in the ranibizumab group, the number of eyes that had received IV triamcinolone, bevacizumab, or ranibizumab prior to entering the current study was 2, 3, and 2 eyes, respectively. Baseline characteristics are summarized in Table 1. At baseline, mean BCVA (logMAR) ± standard error (SE) was 0.60 (Snellen equivalent: 20/80) ± 0.05 and 0.63 (Snellen equivalent: 20/85) ± 0.06 in the IV bevacizumab and IV ranibizumab groups, respectively (P = .680). Intragroup significant improvement in mean BCVA compared with baseline was observed at all study follow-up visits (P < .05).