Evidence map›Paper›PMID 39287660›Full record

ArticleDie Ophthalmologie2024

[Aflibercept in the clinical routine: the AURIGA study : The 24-month results of the German cohort of treatment-naïve patients with diabetic macular edema receiving intravitreal aflibercept].

Michael Ulbig, Christian Karl Brinkmann, Alireza Mirshahi, Hans Hoerauf, Helmut Allmeier, Tobias Machewitz, Paula Scholz, Georgios Keramas, Ramin Khoramnia, Studienärzte der AURIGA-Studie

Abstract readMulticenter StudyEnglish Abstract
PubMed Publisher
In one paragraph

Article in Die Ophthalmologie, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

10 authors.

Michael UlbigKlinik und Poliklinik für Augenheilkunde der Technischen Universität München, Ismaninger Straße 22, 81675, München, Deutschland. Michael.Ulbig@mri.tum.de.ORCID http://orcid.org/0000-0001-5961-0039
Christian Karl BrinkmannKlinik für Augenheilkunde, Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Deutschland.
Alireza MirshahiAugenklinik Dardenne, Bonn, Deutschland.
Hans HoeraufAugenklinik der Universitätsmedizin Göttingen, Göttingen, Deutschland.
Helmut AllmeierBayer Consumer Care AG, Basel, Schweiz.
Tobias MachewitzBayer AG, Berlin, Deutschland.
Paula ScholzBayer Vital GmbH, Leverkusen, Deutschland.
Georgios KeramasBayer Vital GmbH, Leverkusen, Deutschland.
Ramin KhoramniaUniversitäts-Augenklinik Heidelberg, Heidelberg, Deutschland.
Studienärzte der AURIGA-Studie

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion. This article presents 24-month data from the German cohort of treatment-naïve patients with DME.

methodsTreatment-naïve patients (≥ 18 years) with DME were treated with IVT-AFL at the discretion of the physician in clinical practice. The primary endpoint was mean change in visual acuity (early treatment diabetic retinopathy, ETDRS, letters) at month 12 compared to baseline. Statistical analyses were descriptive.

resultsThe analysis included data from 150 DME patients (54.7% male). At months 6, 12 and 24, mean (95% confidence interval) visual acuity gains of 4.6 (2.6; 6.5), 4.0 (2.1; 6.5) and 5.0 (3.0; 6.9) letters from baseline (mean ±SD: 65.0 ± 15.3 letters) and reductions in retinal thickness of 86µm (109; 64µm), 70µm (94; 43µm) and 75µm (103; 47µm) from baseline (mean ±SD: 391 ± 132 µm), respectively, were achieved. At month 24, 54% of patients gained ≥ 5 letters and 22% ≥ 15 letters. Patients received a mean number of 5.0 ± 1.6 injections until month 6, 7.1 ± 3.2 until month 12 and 9.0 ± 5.3 until month 24, 68% of patients received ≥ 5 injections until month 6 and 56% ≥ 7 injections within the first year. The safety profile was consistent with previous studies. DISCUSSION: In the German AURIGA cohort, treatment-naïve DME patients achieved a clinically relevant gain in visual acuity as well as reduction in central retinal thickness following IVT-AFL treatment in clinical practice. From month 6 onwards, improvements were maintained despite a low injection frequency over 24 months. In comparison with previous real-world studies, care of DME patients in clinical practice seems to have improved; however, there is still room for further improvement.

Indexed as

Diabetic RetinopathyIntravitreal InjectionsMacular EdemaReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVisual AcuityAgedAngiogenesis InhibitorsCohort StudiesFemaleFollow-Up StudiesGermanyHumansMaleMiddle AgedProspective StudiesafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsEvidence-based medicineIntravitreal afliberceptMacular edemaQuality of careReal-world study

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.