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Tomomi Higashide, Masaru Inatani, Kenji Matsushita, Mari Ueki, Toshiaki Kubota, Yuji Iwamoto, Masato Kobayashi, Sergio Leal; Efficacy and Safety of Intravitreal Aflibercept Injection (IAI) in Neovascular Glaucoma (NVG): The VEGA Study.. Invest. Ophthalmol. Vis. Sci. 2019;60(9):2398.
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VEGA compared IAI with sham on change of intraocular pressure (IOP) in Japanese patients with NVG.
A randomized 13-week, double-masked, sham-controlled Phase 3 study. Patients with NVG and elevated IOP due to neovascularization (NV) received ≥3 classes of topical IOP-lowering drugs (run-in phase). After the run-in phase, if IOP was >25 mmHg, patients were randomized to IAI or sham injection at baseline (BL). Panretinal photocoagulation (PRP) was allowed at any time. Systemic IOP-lowering drugs were prohibited 24 hours prior to IOP evaluation at BL and Week (W) 1. If retreatment criteria were met, sham patients received IAI at W1, 5, and 9, while IAI patients received sham injections at W1 and IAI at W5 and 9. The primary endpoint was IOP change from BL to W1 (preinjection). Change in NVI grade from BL to W1 was the secondary endpoint. Changes in NV grades and proportion of patients with IOP≤21 mmHg and efficacy results of sham patients receiving IAI at W1 were evaluated at W2.
The full analysis set (FAS) included 27 patients per group while the per protocol set (PPS) included 26 per group. Baseline demographics were balanced, while IOP, primary diagnosis, disease duration and NV grades showed imbalances. Mean IOP change (BL to W1) favored IAI (–9.9; BL, 33.0mmHg; W1, 24.5mmHg) vs sham (–5.0mmHg; BL, 36.7mmHg; W1, 31.8 mmHg; intergroup difference, –4.9mmHg, P=0.06 FAS, P=0.04 PPS). At W1 IAI and sham respectively showed IOP≤21 mmHg in 44.4% vs 7.4%; improvement in NV of the iris (NVI) grade in 70.4% vs 11.5% and in NV of the anterior chamber (NVA) grade in 59.3% vs 11.5%. At W1, 81.5% of sham patients received IAI. In this group, mean IOP changed by –11.8mmHg from 33.7mmHg (W1) to 22.0 mmHg (W2). At W2, this group showed IOP≤21mmHg in 68.2%; improvement in NVI grade in 66.7% and in NVA grade in 57.1%. Outcomes were maintained to W13, with a tendency toward further improvement. Most patients (IAI=77.8% and sham=74.1%) received only 1 IAI. Most common ocular treatment-emergent adverse event in the study eye was punctate keratitis (9.3%).
Within 1 week of treatment, addition of IAI to NVG therapy showed clinically meaningful IOP reductions vs sham in Japanese patients with NVG, narrowly missing the primary endpoint. For most patients, only 1 IAI was required. The safety profile of IAI was similar to previous pivotal studies of IAI in other indications.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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