Cutting Edge Glaucoma - Issue 2

30 • CUTTING EDGE - GLAUCOMA monitored using a risk-based monitoring approach with one onsite visit at the end of the study. Although an interim analysis at 12 months was performed as planned and interim data cuts pre- sented in scientific meetings (listed above), reported herein is the final analysis, performed after completion of the 24-month visit. Results Demographics, Baseline Characteristics, and Surgical Parameters Overall, 240 eyes (217 patients) entered the study and 219 (200 patients) were enrolled (Fig. 1). A total of 218 eyes of 199 patients received the gelatin implant at 21 sites and were included in the safety population. The number (%) of patients implanted at each site ranged from 1 (0.5) to 28 (14.1) (mean 9.5; median 7.0). Overall, 197/218 (90.4%) eyes completed the 12-month visit; 174/218 (79.8%) completed the 24-month visit, while 44/218 (20.2%) discontinued the study (Fig. 1). No eye was withdrawn due to complications from cataract surgery. Data were comparable in the mITT population, with 182/202 (90.1%) and 161/202 (79.7%) eyes completing the 12- and 24-month visits, respectively, and 41/202 (20.3%) discontinuing the study. Patient demograph- ics and baseline characteristics for the mITT population are summarized in Table 1; a total of 25 (23.6%) eyes in the implant alone group were pseudophakic. Adjunctive antifibrotic therapy (administered by subconjunctival injection) was used in all eyes; 99% received mitomycin C (MMC), while the remaining 1% received 5-fluorouracil (5-FU). The time of administration and absolute doses are detailed in Table 2. Effectiveness In the mITT population ( N = 202), the change standard deviation (SD) in mean IOP from preoperative medicated baseline at 12 months (primary time point) was − 6.5 (5.3) mmHg ( P < 0.001). The change (SD) in mean number of IOP-lowering medications was − 1.7 (1.3) ( P < 0.001). Notably, the changes in both outcomes were also statistically significant at all other post-operative visits ( P < 0.001), reaching − 6.2 (4.9) mmHg and − 1.5 (1.4) at month 24, respec- tively (Fig. 2). The mean percentage change in IOP frommedicated baseline was − 29.3% at month 12 and − 27.8% at month 24 (Fig. 2). Overall, results were similar in both treatment arms. The mean changes in IOP from medi- cated baseline were − 6.6 (5.6) and − 6.4 (5.0) mmHg at month 12 and − 6.4 (5.2) and − 5.9 (4.6) mmHg at month 24 in the implant alone and phaco + implant groups, respectively (P > 0.50). In these groups, the mean changes in IOP-lowering medication count were − 1.8 (1.3) and − 1.6 (1.2) at month 12 and − 1.5 (1.5) and − 1.5 (1.2) at month 24, respectively ( P > 0.48). The mean percentage changes in IOP from medicated baseline were − 29.6 (month 12) and − 28.2% (month 24) in the former group and − 29.1 (month 12) and − 27.2% (month 24) in the latter (Fig. 2).