دورية أكاديمية
[Aflibercept in a real-world setting: the AURIGA study : 24-month results of the German cohort of treatment-naïve patients with macular edema following retinal vein occlusion receiving intravitreal aflibercept].
| العنوان: | [Aflibercept in a real-world setting: the AURIGA study : 24-month results of the German cohort of treatment-naïve patients with macular edema following retinal vein occlusion receiving intravitreal aflibercept]. |
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| عنوان ترانسليتريتد: | Aflibercept im klinischen Alltag: die AURIGA-Studie : 24-Monats-Ergebnisse der deutschen Kohorte behandlungsnaiver Patienten mit Makulaödem bei retinalem Venenverschluss unter Therapie mit intravitrealem Aflibercept. |
| المؤلفون: | Wachtlin J; Sankt Gertrauden Krankenhaus, Paretzer Str. 12, 10713, Berlin, Deutschland. Joachim.Wachtlin@sankt-gertrauden.de.; MHB, Medizinische Hochschule Brandenburg, Neuruppin, Deutschland. Joachim.Wachtlin@sankt-gertrauden.de., Kaymak H; Internationale Innovative Ophthalmochirurgie GbR, Düsseldorf, Deutschland., Hoerauf H; Augenklinik, Universitätsmedizin Göttingen, Göttingen, Deutschland., Allmeier H; Bayer Consumer Care AG, Basel, Schweiz., Machewitz T; Bayer AG, Berlin, Deutschland., Scholz P; Bayer Vital GmbH, Leverkusen, Deutschland., Schürks M; Bayer Vital GmbH, Leverkusen, Deutschland., Feltgen N; Augenklinik, Universitätsmedizin Göttingen, Göttingen, Deutschland.; Augenklinik, Universitätsspital Basel, Basel, Schweiz. |
| المصدر: | Die Ophthalmologie [Ophthalmologie] 2024 Aug; Vol. 121 (8), pp. 650-657. Date of Electronic Publication: 2024 Jul 08. |
| نوع المنشور: | Journal Article; Multicenter Study; English Abstract |
| اللغة: | German |
| بيانات الدورية: | Publisher: Springer Medizin Country of Publication: Germany NLM ID: 9918402288106676 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2731-7218 (Electronic) Linking ISSN: 2731720X NLM ISO Abbreviation: Ophthalmologie Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Heidelberg] : Springer Medizin, [2022]- |
| مواضيع طبية MeSH: | Receptors, Vascular Endothelial Growth Factor*/administration & dosage , Receptors, Vascular Endothelial Growth Factor*/therapeutic use , Recombinant Fusion Proteins*/administration & dosage , Recombinant Fusion Proteins*/therapeutic use , Recombinant Fusion Proteins*/adverse effects , Retinal Vein Occlusion*/drug therapy , Retinal Vein Occlusion*/complications , Macular Edema*/drug therapy , Intravitreal Injections* , Visual Acuity*/drug effects, Humans ; Male ; Female ; Aged ; Germany ; Middle Aged ; Prospective Studies ; Treatment Outcome ; Angiogenesis Inhibitors/therapeutic use ; Angiogenesis Inhibitors/administration & dosage ; Angiogenesis Inhibitors/adverse effects ; Follow-Up Studies ; Tomography, Optical Coherence |
| مستخلص: | Background: AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept 2 mg (IVT-AFL) treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) and diabetic macular edema. Here we present the 24-month data from the German cohort of treatment-naïve patients with ME due to RVO. Methods: Treatment-naïve patients with ME secondary to RVO were treated with IVT-AFL 2 mg in the routine clinical practice. The primary endpoint was mean change in visual acuity (VA, early treatment diabetic retinopathy, ETDRS, letters) at month 12 compared to baseline. Analyses were descriptive. Results: Analysis included 130 patients with RVO (n = 61, 46.9% with central RVO, n = 69, 53.1% with branch RVO). The mean (± SD) time the RVO patients remained in the study was 18.4 ± 7.4 months. The mean VA gain (95% confidence interval) in the overall cohort was +10.9 (7.5-14.2) letters at month 12 and +9.7 (6.1-13.3) at month 24 (baseline VA 56.5 ± 18.9 letters). At 24 months, 67% of RVO patients gained ≥5 letters and 40% gained ≥15 letters. The mean number of injections was 4.4 ± 1.3 up to month 6, 6.2 ± 2.7 up to month 12 and 8.2 ± 4.5 up to month 24. The mean central retinal thickness (CRT) reduction was -206µm (-252 to -160µm) at 12 months and -219µm (-263 to -175µm) at 24 months (baseline CRT 507 ± 177 µm). The safety profile was consistent with that of previous studies. Discussion: In the German AURIGA cohort of treatment-naïve patients with ME secondary to RVO, IVT-AFL 2 mg treatment in clinical practice resulted in rapid and clinically relevant VA gains and a reduction in CRT. These results were largely maintained over 24 months despite the low injection frequency from month 6. (© 2024. The Author(s).) |
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| فهرسة مساهمة: | Keywords: Intravitreal aflibercept; Macular edema; Real world; Retinal vein occlusion; Treatment naïve Local Abstract: [Publisher, German] HINTERGRUND: AURIGA ist die größte prospektive Real-World-Studie zur Behandlung eines Makulaödems (MÖ) nach retinalem Venenverschluss (RVV) oder eines diabetischen Makulaödems mit intravitrealem Aflibercept 2 mg (IVT-AFL). Hier werden die 24-Monats-Daten der deutschen behandlungsnaiven RVV-Kohorte mit MÖ präsentiert. [Publisher, German] Behandlungsnaive RVV-Patienten mit MÖ wurden mit IVT-AFL 2 mg in der klinischen Routine therapiert. Primärer Endpunkt war die mittlere Änderung des Visus (ETDRS-Buchstaben) zu Monat 12 gegenüber dem Ausgangswert. Die Analyse erfolgte deskriptiv. [Publisher, German] Es wurden 130 Patienten mit RVV (n = 61 [46,9 %] mit Zentralvenenverschluss, n = 69 [53,1 %] mit Venenastverschluss) untersucht. Im Mittel (± SD) verblieben die RVV-Patienten für 18,4 ± 7,4 Monate in der Studie. Der mittlere Visusgewinn [95 % Konfidenzintervall] betrug in der Gesamtkohorte +10,9 [7,5; 14,2] Buchstaben zu Monat 12 und +9,7 [6,1; 13,3] zu Monat 24 (Baseline 56,5 ± 18,9 Buchstaben). Nach 24 Monaten hatten 67 % der RVV-Patienten ≥5 Buchstaben, 40 % ≥ 15 Buchstaben gewonnen. Von Baseline betrug die mittlere Injektionszahl 4,4 ± 1,3 bis Monat 6, 6,2 ± 2,7 bis Monat 12 und 8,2 ± 4,5 bis Monat 24. Die durchschnittliche Reduktion der zentralen Netzhautdicke (Ausgangswert 507 ± 177 µm) betrug in der Gesamtkohorte −206 (−252; −160) µm nach 12 Monaten und −219 (−263; −175) µm nach 24 Monaten. Das Sicherheitsprofil entsprach dem früherer Studien. [Publisher, German] In der deutschen AURIGA-Kohorte behandlungsnaiver Patienten mit MÖ infolge RVV unter IVT-AFL-2 mg-Behandlung zeigten sich im klinischen Alltag ein rascher und klinisch relevanter Visusgewinn sowie eine Reduktion der zentralen Netzhautdicke. Diese wurden trotz niedriger Injektionsfrequenz ab Monat 6 über 24 Monate weitestgehend erhalten. |
| المشرفين على المادة: | EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor) 15C2VL427D (aflibercept) 0 (Recombinant Fusion Proteins) 0 (Angiogenesis Inhibitors) |
| تواريخ الأحداث: | Date Created: 20240708 Date Completed: 20240802 Latest Revision: 20240802 |
| رمز التحديث: | 20240802 |
| DOI: | 10.1007/s00347-024-02051-3 |
| PMID: | 38976039 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. | تدمد: | 2731-7218 |
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| DOI: | 10.1007/s00347-024-02051-3 |