Evidence map›Paper›PMID 37924483›Full record

ArticleOphthalmology and therapy2024

Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema in Routine Clinical Practice: Results from the 24-Month AURIGA Observational Study.

Simone Donati, Chang-Hao Yang, Xun Xu, Marco Mura, Audrey Giocanti-Aurégan, Hans Hoerauf, Helmut Allmeier, Tobias Machewitz, Kristian T Johnson, Elina Santoro and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03161912 (An Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

NCT03161912 completednot on this map

An Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting

TypeobservationalSponsorBayerRan2017 to 2021Enrolled2,481ConditionsMacular EdemaArmsAflibercept (Eylea, BAY86-5321)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

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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 10 institutions in 9 countries.

Simone DonatiDepartment of Medicine and Surgery, University of Insubria, Via Guicciardini 9, 21100, Varese, Italy. simone.donati@uninsubria.it.ORCID http://orcid.org/0000-0002-6920-7021
Chang-Hao YangDepartment of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan.
Xun XuDepartment of Ophthalmology, Shanghai General Hospital, Shanghai, China.ORCID http://orcid.org/0000-0002-4246-4343
Marco MuraKing Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia.ORCID http://orcid.org/0000-0001-5283-5366
Audrey Giocanti-AuréganHôpital Avicenne, Sorbonne Paris Nord University, Bobigny, France.ORCID http://orcid.org/0000-0002-7918-7845
Hans HoeraufAugenklinik, Universitätsmedizin Göttingen, Göttingen, Germany.
Helmut AllmeierBayer Consumer Care AG, Basel, Switzerland.ORCID http://orcid.org/0000-0002-5165-4851
Tobias MachewitzBayer AG, Berlin, Germany.
Kristian T JohnsonBayer U.S. LLC, Cambridge, MA, USA.
Elina SantoroSurgut Regional Clinical Hospital, Surgut, Russia.
AURIGA study investigators
Bayer (Germany) · DEBayer (Switzerland) · CHBayer (United States) · USKing Khaled Eye Specialist Hospital · SANational Taiwan University · TWShanghai First People's Hospital · CNSurgut State University · RUUniversitätsmedizin Göttingen · DEUniversité Sorbonne Paris Nord · FRUniversity of Insubria · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) in the treatment of diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion in routine clinical practice. The 24-month outcomes in the DME cohort from across 11 participating countries are reported here.

methodsAURIGA (NCT03161912) was a prospective observational study. The study enrolled eligible patients with DME for whom the decision to treat with IVT-AFL had previously been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month 12 (M12). All statistical analyses were descriptive.

resultsIn 1478 treatment-naïve and 384 previously treated patients with DME, the mean (95% confidence interval) change in VA from baseline was +6.7 (5.7, 7.6) and +7.4 (5.5, 9.4) letters by M12 and +5.9 (4.9, 6.9) and +8.1 (6.1, 10.1) letters by M24 (baseline [mean ± standard deviation]: 56.0 ± 19.8 and 50.8 ± 19.5 letters), respectively; 25.9% of treatment-naïve and 32.8% of previously treated patients achieved ≥ 15-letter gains by M24. The mean change in central retinal thickness from baseline to M24 was -110 (-119, -102) µm in treatment-naïve patients and -169 (-188, -151) µm in previously treated patients. By M6, M12, and M24, treatment-naïve patients had received 3.8 ± 1.7, 4.9 ± 2.8, and 5.7 ± 3.9 injections, respectively, and previously treated patients had received 3.9 ± 1.5, 4.9 ± 2.4, and 6.2 ± 3.6 injections, respectively. The safety profile of IVT-AFL was consistent with previous studies.

conclusionIn AURIGA, treatment-naïve and previously treated patients with DME achieved clinically relevant functional and anatomic improvements following IVT-AFL treatment for up to 24 months in routine clinical practice. Even with the decreasing injection frequency observed, these gains were largely maintained throughout the study, suggesting long-term durability of the positive effects of IVT-AFL treatment. Infographic available for this article.

trial registrationClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017). INFOGRAPHIC.

Indexed as

Anti-vascular endothelial growth factorDiabetesDiabetic macular edemaDiabetic retinopathyIntravitreal afliberceptObservational studyReal-world evidenceRetinal disease

Identifiers

PMID37924483
PMCPMC10776528
OpenAlexW4388338109

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.