Evidence map›Paper›PMID 33330958›Full record

Trial reportAdvances in therapy2021

Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial.

Masaru Inatani, Tomomi Higashide, Kenji Matsushita, Atsuya Miki, Mari Ueki, Yuji Iwamoto, Masato Kobayashi, Sergio Leal, VEGA Investigators

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
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 NCT02396316 (A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 21% 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.

NCT02396316 phase3completednot on this map

A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma

TypeinterventionalSponsorBayerRan2015 to 2016Enrolled54ConditionsGlaucoma, NeovascularArmsAflibercept (Eylea, BAY 86-5321), Sham Injection
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Anti-vascular endothelial growth factor for neovascular glaucoma.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Article
  4. Review
  5. Observational
  6. Article
  7. Review
  8. Review
  9. Review
  10. 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

9 authors at 6 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, Osaka, Japan.
Atsuya MikiDepartment of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
Mari UekiDepartment of Ophthalmology, Osaka Medical College, Takatsuki-City, Osaka, Japan.
Yuji IwamotoBayer Yakuhin, Ltd., Osaka, Japan.
Masato KobayashiBayer Yakuhin, Ltd., Osaka, Japan.
Sergio LealBayer Consumer Care AG, Basel, Switzerland.
VEGA Investigators
Bayer (Switzerland) · CHKanazawa University · JPOsaka Medical and Pharmaceutical University · JPBayer (Japan) · JPThe University of Osaka · 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 the anterior angle chamber. Intravitreal anti-vascular endothelial growth factor agents may improve intraocular pressure (IOP) and neovascularization.

methodsThe VEGA trial assessed the efficacy and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma in a 13-week, randomized, double-masked, sham-controlled, phase 3 study performed at multiple sites in Japan that enrolled patients with anterior segment neovascularization and IOP > 25 mmHg. Patients received background therapy plus IVT-AFL (2 mg) or sham injection at baseline. Patients were re-treated if presenting with IOP > 21 mmHg and incomplete regression of iris neovascularization, receiving additional sham or IVT-AFL injections at week 1 and IVT-AFL injections at weeks 5 and/or 9. Double-masking was maintained throughout. The primary endpoint was change in IOP from baseline to week 1.

resultsFifty-four patients were randomly assigned (full analysis set); the per-protocol set comprised 52 patients. At week 1, the least squares mean change in IOP was -9.9 mmHg for IVT-AFL versus -5.0 mmHg for sham [full analysis set: difference -4.9 mmHg (95% confidence interval -10.2 to 0.3; P = 0.06); per-protocol set: -5.5 mmHg (95% CI -10.8 to -0.2; P = 0.04)]. At week 1, a greater proportion of patients administered IVT-AFL versus sham achieved IOP ≤ 21 mmHg and had improved neovascularization grades. Patients in the sham group who met re-treatment criteria and received IVT-AFL at week 1 [n = 22 (81.5%)] had an additional mean IOP decrease of 9.2 mmHg by week 2, and the proportion with improvement in neovascularization grades increased from 11.5% to 69.2%. Increases in the proportion of patients with improved neovascularization grades and the proportion who achieved IOP control (≤ 21 mmHg) were also observed by week 2 in this group. Overall, 77.8% and 74.1% of patients treated with IVT-AFL and sham/IVT-AFL, respectively, received a single IVT-AFL injection. The most common ocular treatment-emergent adverse event was punctate keratitis (9.3%: 7.4% and 11.1% in the IVT-AFL and sham/IVT-AFL groups, respectively).

conclusionsIVT-AFL was associated with clinically meaningful improvements in IOP control, indicating that IVT-AFL may be a potential treatment option for patients with neovascular glaucoma.

trial registrationClinicaltrials.gov identifier, NCT02396316.

Indexed as

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

Identifiers

PMID33330958
PMCPMC7889669
OpenAlexW3111645684

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.