PU Conference Series: Euretina 2018

Intravitreal Injection of Aflibercept Shows Promise in Managing Neovascular Glaucoma Intraocular pressure and neovascularization grade were meaningfully reduced one week after injection.

I ntravitreal injection of aflibercept within one week of treatment may reduce intraocular pres- sure (IOP) to a clinically meaningful degree in patients with neovascular glaucoma, according to the results of the phase III VEGA study. The VEGA investigators performed a randomized, double-masked, sham-controlled study to assess the safety and efficacy of intravitreal injection of aflibercept in the management of high IOP among a population of Japanese patients with neovascular glaucoma. Their results were presented by Masaru Inatani, MD, of the University of Fukui in Japan. Patients enrolled in the study were at least 20 years old, with IOP > 25 mmHg attributed to neovascularization of the anterior segment. Prior to randomization, all patients received a run-in pretreatment consisting of topical IOP-lowering drugs from at least three classes. They were then randomized to receive either intravitreal afliber- cept injections or sham injection at baseline and followed for 13 weeks. The primary endpoint was change in IOP from baseline to week 1. Change in neovascularization of the iris grade from baseline to week 1 comprised a secondary endpoint. A total of 54 patients from the intent-to-treat study population contributed data to the full analysis set (n=27 from each arm). A second analysis was performed on a per protocol set, comprising data from 52 patients (n=26 from each arm). The VEGA investigators identified a clinically meaningful reduction in IOP within the afliber- cept-treated arm of the full analysis population, and a statistically significant reduction in IOP within the aflibercept-treated arm of the per protocol popula- tion, both relative to sham. For the full analysis set, the least squares mean IOP change from baseline to week 1 was –9.9 mmHg in the aflibercept arm vs –5.0 mmHg in the sham arm (P = .06). For the per protocol population, the least squares mean IOP change from baseline to week 1 was –10.2 mmHg for the aflibercept arm vs –4.7 mm Hg for the sham arm (P = .04).

At week 1, relative to patients receiving sham at baseline, a greater proportion of patients in the full analysis set who had received aflibercept at baseline experienced IOP ≤ 21 mmHg (44.4% vs 7.4%) and improvement in iris neovascularization grade (70.4% vs 11.5%). These improvements were typically maintained through week 13. Treatment-emergent adverse events occurred in 48.1% of patients in the aflibercept-treated arm and 74.1% of patients in the sham arm. The most com- mon ocular adverse events were punctate keratitis (9.3%) and eye pain (7.4%). This safety profile was similar to the profile previously observed in other aflibercept intravitreal injection studies. Based on these results, the VEGA researchers conclude that, despite narrowly missing the sta- tistical cutoff for a significant result in the primary intention-to-treat study outcome, intravitreal injec- tion of aflibercept offers patients with neovascular glaucoma clinically meaningful reductions in IOP in addition to improvement in anterior segment neovascularization. Notably, patients who met eligibility criteria could receive retreatment at weeks 1, 5, and 9: Patients

8

PRACTICEUPDATE CONFERENCE SERIES • EURETINA 2018