June 2020
Volume 61, Issue 7
ARVO Annual Meeting Abstract  |   June 2020
Efficacy and safety of intravitreal aflibercept injection in Japanese patients with neovascular glaucoma: Outcomes from the VEGA and VENERA studies
Author Affiliations & Notes
  • Kenji Matsushita
    Ophthalmology, Osaka University Medical School, Suita, OSAKA, Japan
  • Tomomi Higashide
    Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Osaka, Japan
  • Masaru Inatani
    Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan
  • Yuji Iwamoto
    Bayer Yakuhin, Ltd, Osaka, Japan
  • Masato Kobayashi
    Bayer Yakuhin, Ltd, Osaka, Japan
  • Sergio Leal
    Bayer Consumer Care AG, Pharmaceuticals, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Kenji Matsushita, Alcon Pharma (R), Bayer (R), Kowa (R), Nitten (R), Otsuka (R), Pfizer (R), Santen (R), Senju (R), Sucampo Pharma (R), Yakuhin (R); Tomomi Higashide, None; Masaru Inatani, Bayer (C), Bayer (R); Yuji Iwamoto, Bayer (E); Masato Kobayashi, Bayer (E); Sergio Leal, Bayer (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 4255. doi:
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      Kenji Matsushita, Tomomi Higashide, Masaru Inatani, Yuji Iwamoto, Masato Kobayashi, Sergio Leal; Efficacy and safety of intravitreal aflibercept injection in Japanese patients with neovascular glaucoma: Outcomes from the VEGA and VENERA studies. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4255.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : The VEGA study showed intravitreal aflibercept (IVT-AFL) reduced intraocular pressure (IOP) in patients with neovascular glaucoma (NVG); however, the use of systemic IOP-lowering drugs limited the interpretation of the primary efficacy outcome. The VENERA study was designed to confirm the IOP-lowering effect of IVT-AFL and complement the efficacy evaluation from VEGA without the confounding effect of systemic IOP-lowering drugs.

Methods : VEGA (NCT02396316) was a 13-week, randomized, double-masked, sham-controlled study. VENERA (NCT03639675) was a 5-week, single-arm, open-label study. Both were Phase 3 studies conducted in Japan and, after a run-in phase of topical IOP-lowering drugs, if IOP was >25mmHg, patients received one 2mg dose of IVT-AFL (or sham injection in VEGA). Primary endpoint was change in IOP from baseline (BL) to Week (W) 1. Secondary endpoint was change in neovascularization of the iris (NVI) grade (BL to W1). In VEGA, systemic IOP-lowering drugs were prohibited 24 hours prior to IOP evaluation at BL and at W1; whereas in VENERA, they were prohibited from 3 days prior to BL until IOP evaluation at W1.

Results : Overall, 27 patients per group were included in VEGA. Least squares mean IOP change (BL to W1) was –9.9mmHg (BL 33.0mmHg; W1 24.5mmHg) and –5.0mmHg (BL 36.7mmHg; W1 31.8mmHg) in the IVT-AFL and sham groups, respectively; intergroup difference: −4.9mmHg (95% CI: −10.2, 0.3; P=0.06). Overall, 16 patients were included in VENERA. Mean IOP decreased from 34.1mmHg at BL to 25.8mmHg at W1 (mean change: −8.3mmHg [95% CI: −12.2, −4.4; P=0.0004]). At W1, 70.4% and 11.5% of patients (IVT-AFL and sham, respectively; VEGA) and 81.3% of patients (VENERA) had an improvement in NVI grade. Most common ocular treatment-emergent adverse events were punctate keratitis (9.3%; VEGA) and eye pain (25.0%; VENERA).

Conclusions : In VEGA, addition of IVT-AFL to NVG therapy showed numerically superior and clinically meaningful IOP reductions vs sham at W1 in patients with NVG, narrowly missing the primary endpoint. In VENERA, treatment with IVT-AFL achieved statistically significant and clinically meaningful IOP reductions similar to those of VEGA, while prohibiting systemic IOP-lowering drugs. The safety profile was consistent with the known safety profile of IVT-AFL.

This is a 2020 ARVO Annual Meeting abstract.


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