Evidence map›Paper›PMID 32016788›Full record

Trial reportAdvances in therapy2020

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial.

Masahito Ohji, Kanji Takahashi, Annabelle A Okada, Masato Kobayashi, Yoshimi Matsuda, Yasuhiro Terano, ALTAIR Investigators

Registry-linked trialAbstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02305238 (A Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration), which is not on this map. Cited by 164 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
164citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT02305238 phase4completednot on this map

A Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration

TypeinterventionalSponsorBayerRan2014 to 2017Enrolled288ConditionsWet Macular DegenerationArmsAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
3 · Its place in the literature

Who cites it

164 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Guideline
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  5. Anti-Vascular Endothelial Growth Factor Therapy Regimens for Polypoidal Choroidal Vasculopathy: A Systematic Review.Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde · 2023
    Pooled it
  6. Pooled it
  7. Disease stability and extended dosing under anti-VEGF treatment of exudative age-related macular degeneration (AMD) - a meta-analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
    Pooled it
  8. Trial
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  10. A post-hoc analysis of intravitreal aflibercept-treated nAMD patients from ARIES & ALTAIR: predicting treatment intervals and frequency for aflibercept treat-and-extend therapy regimen using machine learning.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
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  14. A randomized, open-label, multicenter study of switching to brolucizumab with or without a loading dose for patients with suboptimal anatomically controlled neovascular age-related macular degeneration-the FALCON study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022
    Trial
  15. To investigate treat and extend versus pro re nata regimen in neovascular age-related macular degeneration: results from the IDEM study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022
    Trial
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  19. Review
  20. Article

104 more citing papers are in PubMed but not listed here.

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

7 authors.

Masahito OhjiDepartment of Ophthalmology, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Shiga, Japan. eye.ohji@gmail.com.
Kanji TakahashiDepartment of Ophthalmology, Kansai Medical University, School of Medicine, Hirakata City, Osaka, Japan.
Annabelle A OkadaDepartment of Ophthalmology, Kyorin University, School of Medicine, Mitaka-shi, Tokyo, Japan.
Masato KobayashiBayer Yakuhin Ltd, Marunouchi 1-chome, Chiyoda-ku, Tokyo, Japan.
Yoshimi MatsudaBayer Yakuhin Ltd, Umeda 2-chome, Kita-ku, Osaka, Japan.
Yasuhiro TeranoBayer Yakuhin Ltd, Umeda 2-chome, Kita-ku, Osaka, Japan.
ALTAIR Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).

methodsAdults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2- or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96.

resultsBaseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2- and 4-week groups, respectively. From baseline, mean change in BCVA was + 9.0 and + 8.4 letters (week 52) and + 7.6 and + 6.1 letters (week 96); mean change in central retinal thickness was - 134.4 µm and - 126.1 µm (week 52) and - 130.5 µm and - 125.3 µm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports.

conclusionsIVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were maintained to week 96. Outcomes were similar between the 2- and 4-week groups.

trial registrationClinicalTrials.gov identifier, NCT02305238.

Indexed as

AgedAged, 80 and overAngiogenesis InhibitorsDrug Administration ScheduleFemaleHumansIntravitreal InjectionsMacular DegenerationMaleMiddle AgedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTreatment OutcomeVisual AcuityafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAfliberceptAnti-vascular endothelial growth factor agentsExudative age-related macular degenerationOphthalmologyTreat-and-extend

Identifiers

PMID32016788
PMCPMC7089719

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.