Evidence map›Paper›PMID 33330959›Full record

Trial reportAdvances in therapy2021

Efficacy and Safety of Intravitreal Aflibercept Injection in Japanese Patients with Neovascular Glaucoma: Outcomes from the VENERA Study.

Masaru Inatani, Tomomi Higashide, Kenji Matsushita, Daisuke Nagasato, Hitoshi Takagi, Mari Ueki, Yasuyuki Takai, Ken Miyazaki, Yuji Iwamoto, Masato Kobayashi and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03639675 (A Single-arm, Non-randomized and Open-label Phase 3 Study Evaluating the Efficacy, Safety and Tolerability of Intravitreal Aflibercept in Japanese Patients With Neovascular Glaucoma), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03639675 phase3completednot on this map

A Single-arm, Non-randomized and Open-label Phase 3 Study Evaluating the Efficacy, Safety and Tolerability of Intravitreal Aflibercept in Japanese Patients With Neovascular Glaucoma (NVG)

TypeinterventionalSponsorBayerRan2018 to 2019Enrolled16ConditionsGlaucoma, NeovascularArmsAflibercept (EYLEA, BAY86-5321), Topical IOP-lowering drugs
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Anti-vascular endothelial growth factor for neovascular glaucoma.The Cochrane database of systematic reviews · 2023
    Pooled it
  4. Trial
  5. Article
  6. Observational
  7. Review
  8. Review
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 2 countries.

Masaru InataniDepartment of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan. inatani@u-fukui.ac.jp.
Tomomi HigashideDepartment of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
Kenji MatsushitaDepartment of Ophthalmology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Daisuke NagasatoDepartment of Ophthalmology, Saneikai Tsukazaki Hospital, Hyogo, Japan.
Hitoshi TakagiDepartment of Ophthalmology, St. Marianna University School of Medicine, Kanagawa, Japan.
Mari UekiDepartment of Ophthalmology, Osaka Medical College, Takatsuki, Osaka, Japan.
Yasuyuki TakaiDepartment of Ophthalmology, Faculty of Medicine, Shimane University, Shimane, Japan.
Ken MiyazakiBayer Yakuhin, Ltd., Osaka, Japan.
Yuji IwamotoBayer Yakuhin, Ltd., Osaka, Japan.
Masato KobayashiBayer Yakuhin, Ltd., Osaka, Japan.
Sergio LealBayer Consumer Care AG, Basel, Switzerland.
Bayer (Japan) · JPBayer (Switzerland) · CHKanazawa University · JPOsaka Medical and Pharmaceutical University · JPOsaka University · JPShimane University · JPSt. Marianna University School of Medicine · JPUniversity of Fukui · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNeovascular glaucoma is characterized by neovascularization of the iris and anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may decrease intraocular pressure (IOP) and improve neovascularization. The VENERA study assessed the efficacy and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma.

methodsThis was a 5-week, single-arm, nonrandomized, open-label, phase 3 study performed at 7 study sites in Japan that enrolled Japanese patients with anterior segment neovascularization and IOP > 25 mmHg who had not undergone (within 30 days prior), nor were imminently scheduled to undergo (within 8 days following) intraocular surgeries, including panretinal photocoagulation (PRP). Patients received background therapy plus 2 mg IVT-AFL at baseline. Background therapy with systemic IOP-lowering drugs was prohibited for 3 days before day 1 and until IOP evaluation at week 1. The primary endpoint was the change in IOP from baseline to week 1 and the secondary endpoint was the proportion of patients with an improvement of ≥ 1 grade of neovascularization of the angle (NVA) from baseline to week 1.

resultsSixteen patients received treatment (full analysis set); the per-protocol set comprised 15 patients. The mean IOP decreased from 34.1 mmHg at baseline to 25.8 mmHg at week 1 (mean change, -8.3 mmHg [95% confidence interval; CI -12.2 to -4.4; P = 0.0004]). At week 1, 81.3% of patients had an improvement in the grade of neovascularization of the iris (NVI) and 50.0% of patients had an improvement in NVA grade. The proportion of patients with controlled IOP (≤ 21 mmHg) was 43.8% (95% CI 19.8-70.1) at week 1, and increased to 56.3% at week 2 and 86.7% at week 5. The most common ocular treatment-emergent adverse event was eye pain, which occurred in 4 patients (25.0%).

conclusionsIVT-AFL was associated with statistically significant and clinically meaningful IOP reductions, without concomitant use of systemic IOP-lowering drugs or PRP. The safety profile was consistent with the known safety profile of IVT-AFL. These findings supplement those from the previous VEGA study, and suggest that IVT-AFL may be a potential treatment option for patients with neovascular glaucoma.

trial registrationClinicaltrials.gov identifier NCT03639675.

Indexed as

Glaucoma, NeovascularAngiogenesis InhibitorsBevacizumabHumansIntraocular PressureIntravitreal InjectionsJapanReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptAngiogenesis InhibitorsBevacizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAnti-vascular endothelial growth factorAnti-VEGFIntraocular pressureIntravitreal afliberceptNeovascular glaucomaNeovascularization of the angleNeovascularization of the irisNVG

Identifiers

PMID33330959
PMCPMC7889553
OpenAlexW3112012936

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.