Evidence map›Paper›PMID 37924481›Full record

ArticleOphthalmology and therapy2024

Real-World Management of Macular Edema Secondary to Retinal Vein Occlusion with Intravitreal Aflibercept: 24-month Results from the AURIGA Observational Study.

Audrey Giocanti-Aurégan, Simone Donati, Hans Hoerauf, Helmut Allmeier, Kay D Rittenhouse, Tobias Machewitz, Chang-Hao Yang, AURIGA Study Investigators

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
2.8field-weighted citation impact, top 9% 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, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Article
  6. Correlation between macular perfusion status and visual acuity in retinal vein occlusion.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Article
  7. Genes · 2024
    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

8 authors at 7 institutions in 6 countries.

Audrey Giocanti-AuréganDepartment of Ophthalmology, Hôpital Avicenne, Sorbonne Paris Nord University, AP-HP, 125 Rue de Stalingrad, Cedex 93009, Bobigny, France. audrey.giocanti@aphp.fr.ORCID http://orcid.org/0000-0002-7918-7845
Simone DonatiDepartment of Medicine and Surgery, University of Insubria, Varese, Italy.ORCID http://orcid.org/0000-0002-6920-7021
Hans HoeraufAugenklinik der Universitätsmedizin Göttingen, Göttingen, Germany.
Helmut AllmeierBayer Consumer Care AG, Basel, Switzerland.ORCID http://orcid.org/0000-0002-5165-4851
Kay D RittenhouseBayer USA LLC, Whippany, NJ, USA.ORCID http://orcid.org/0000-0001-7503-5759
Tobias MachewitzBayer AG, Berlin, Germany.
Chang-Hao YangNational Taiwan University Hospital, Taipei, Taiwan.
AURIGA Study Investigators
Bayer (Germany) · DEBayer (Switzerland) · CHBayer (United States) · USNational Taiwan University Hospital · TWUniversitätsmedizin 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) treatment of diabetic macular edema or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice. Here, we report the 24-month outcomes in the RVO cohort from France, Germany, Italy, and Taiwan.

methodsAURIGA (NCT03161912) was a prospective observational study. Eligible patients with RVO were enrolled for whom the decision to treat with IVT-AFL had already 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 (M) 12. All statistical analyses were descriptive.

resultsIn 554 treatment-naïve and 65 previously treated patients with RVO, the respective mean (95% confidence interval) change in VA from baseline was + 12.5 (10.8, 14.3) and + 7.9 (3.3, 12.6) letters by M12 and + 11.4 (9.4, 13.3) and + 4.4 (- 0.6, 9.5) letters by M24 (baseline mean ± standard deviation: 51.0 ± 21.9 and 51.9 ± 20.4 letters); 44.0% of treatment-naïve and 27.9% of previously treated patients reported ≥ 15-letter gains by M24. By M24, the mean change in central retinal thickness from baseline was - 247 (- 267, - 227) µm in treatment-naïve patients and - 147 (- 192, - 102) µm in previously treated patients. From baseline to M6, M12, and M24, treatment-naïve patients received a total of 4.0 ± 1.3, 5.5 ± 2.5, and 6.9 ± 4.2 injections, respectively, and previously treated patients received 3.8 ± 1.5, 5.0 ± 2.2, and 6.3 ± 3.7 injections, respectively. The safety profile of IVT-AFL was consistent with that of previous studies.

conclusionsIn AURIGA, patients with RVO experienced clinically relevant functional and anatomic improvements following IVT-AFL treatment in routine clinical practice. These improvements were largely maintained in treatment-naïve patients over the 24-month study despite the decreasing treatment frequency, suggesting long-term durability of IVT-AFL treatment outcomes. Infographic available for this article.

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

Indexed as

Anti-vascular endothelial growth factorBranch retinal vein occlusionCentral retinal vein occlusionIntravitreal afliberceptMacular edemaObservational studyOptical coherence tomographyReal-world evidenceRetinal diseaseRetinal vein occlusion

Identifiers

PMID37924481
PMCPMC10776559
OpenAlexW4388338266

What Socratic 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 Socratic graph.