Evidence map›Paper›PMID 35503499›Full record

Trial reportAdvances in therapy2022

Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in the ALTAIR Study: 96-Week Outcomes in the Polypoidal Choroidal Vasculopathy Subgroup.

Annabelle A Okada, Kanji Takahashi, Masahito Ohji, SungChul Charles Moon, Tobias Machewitz, Koji Sasaki, ALTAIR Study Investigators

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2022. 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 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Pachychoroid disease: review and update.Eye (London, England) · 2025
    Review
  10. Article
  11. Two-year outcomes of intravitreal brolucizumab for neovascular age-related macular degeneration: treat, extend, and stop-protocol.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article
  12. 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

7 authors.

Annabelle A OkadaDepartment of Ophthalmology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan. aokada@e23.jp.ORCID http://orcid.org/0000-0002-8850-8962
Kanji TakahashiDepartment of Ophthalmology, Kansai Medical University, Osaka, Japan.
Masahito OhjiDepartment of Ophthalmology, Shiga University of Medical Science, Otsu, Shiga, Japan.
SungChul Charles MoonDepartment of Medical Affairs and Pharmacovigilance, Bayer AG, Berlin, Germany.
Tobias MachewitzDepartment of Research and Development, Bayer AG, Berlin, Germany.
Koji SasakiDepartment of Medical Affairs and Pharmacovigilance, Bayer Yakuhin Ltd., Osaka, Japan.
ALTAIR Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo explore the efficacy and safety of intravitreal aflibercept (IVT-AFL) proactive, individualized treat-and-extend (T&E) regimens in exudative age-related macular degeneration (AMD) in the subgroup of patients with polypoidal choroidal vasculopathy (PCV) enrolled in the ALTAIR study.

methodsThis was a PCV subgroup analysis of ALTAIR, a 96-week, randomized, open-label, phase 4 study in treatment-naïve patients with exudative AMD in Japan. Following three initial monthly doses, patients received IVT-AFL at week 16 and were randomized 1:1 to T&E regimens with either 2-week (IVT-AFL-2W) or 4-week (IVT-AFL-4W) adjustments. The primary endpoint of ALTAIR was the mean change in best-corrected visual acuity (BCVA) from baseline to week 52. Endpoints were assessed at weeks 52 and 96. Safety analyses were conducted.

resultsA total of 90 patients with PCV were included within the full analysis set. From baseline to week 52, mean [standard deviation (SD)] change in BCVA was + 7.5 (14.7) letters and + 8.2 (11.6) letters in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. From baseline to week 96, 91.3% and 90.9% of patients maintained vision in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. From baseline to week 52, mean (SD) change in central retinal thickness was - 153 (177) µm and -112 (122) µm in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. Overall, 51.1% of patients (IVT-AFL-2W, 43.5%; IVT-AFL-4W, 59.1%) achieved a treatment interval of 16 weeks between weeks 16 and 96. The safety profile of IVT-AFL was consistent with previous studies.

conclusionIn treatment-naïve patients with PCV, IVT-AFL administered using two different T&E regimens improved and maintained functional and anatomic outcomes over 96 weeks while minimizing treatment burden.

trial registrationClinicalTrials.gov identifier, NCT02305238.

Indexed as

Eye DiseasesVascular DiseasesAngiogenesis InhibitorsHumansIntravitreal InjectionsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTomography, Optical CoherenceTreatment OutcomeVisual AcuityafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAnatomic outcomesExudative age-related macular degenerationFunctional outcomesIntravitreal afliberceptPolypoidal choroidal vasculopathyTreat-and-extendTreatment interval

Identifiers

PMID35503499
PMCPMC9123052

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.