دورية أكاديمية
EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN.
| العنوان: | EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN. |
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| المؤلفون: | Terasaki H; Department of Ophthalmology, Nagoya University Hospital, Nagoya, Japan., Shiraki K; Department of Ophthalmology and Visual Sciences, Osaka City University, Osaka, Japan., Ohji M; Department of Ophthalmology, Shiga University of Medical Science, Otsu, Japan., Metzig C; Bayer AG, Berlin, Germany., Schmelter T; Bayer AG, Berlin, Germany., Zeitz O; Bayer AG, Berlin, Germany., Sowade O; Bayer AG, Berlin, Germany., Kobayashi M; Bayer Pharmaceuticals, Osaka, Japan., Vitti R; Regeneron Pharmaceuticals, Tarrytown, New York., Berliner A; Regeneron Pharmaceuticals, Tarrytown, New York., Shiraga F; Department of Ophthalmology, Okayama University Medical School, Okayama, Japan. |
| المصدر: | Retina (Philadelphia, Pa.) [Retina] 2019 May; Vol. 39 (5), pp. 938-947. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 8309919 Publication Model: Print Cited Medium: Internet ISSN: 1539-2864 (Electronic) Linking ISSN: 0275004X NLM ISO Abbreviation: Retina Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: Philadelphia : Lippincott, [1981?- |
| مواضيع طبية MeSH: | Visual Acuity*, Diabetic Retinopathy/*drug therapy , Macula Lutea/*pathology , Macular Edema/*drug therapy , Receptors, Vascular Endothelial Growth Factor/*administration & dosage , Recombinant Fusion Proteins/*administration & dosage, Aged ; Diabetic Retinopathy/complications ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Intravitreal Injections ; Japan ; Macular Edema/etiology ; Male ; Middle Aged ; Receptors, Vascular Endothelial Growth Factor/antagonists & inhibitors ; Treatment Outcome |
| مستخلص: | Purpose: To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) in Japanese patients with diabetic macular edema (DME). Methods: VIVID-DME was a Phase 3 study comprising patients with DME randomized 1:1:1 to IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 4 weeks until Week 16 then 8-week dosing (2q8), and laser. A total of 403 patients (76 Japanese) were included in this study. VIVID-Japan (72; all Japanese patients) was a nonrandomized, open-label study comprising Japanese patients with DME receiving IAI 2q4 until Week 16, then 2q8. Primary efficacy endpoint (Week 52) of VIVID-DME was mean change from baseline in best-corrected visual acuity; VIVID-Japan evaluated safety and tolerability. Results: Mean change in best-corrected visual acuity (letters) for 2q4, 2q8, and laser groups was +10.6, +10.9, and +1.2 and +9.8, +9.5, and +1.1 in the non-Japanese and Japanese populations of VIVID-DME, respectively. In VIVID-Japan, it was +9.3 for IAI 2q8. Intravitreal aflibercept injection also provided consistently greater benefits for anatomical outcomes versus laser. Adverse events were consistent with the known safety profile of IAI. Conclusion: In Japanese patients with DME, IAI treatment was superior to laser for visual and anatomical outcomes and resulted in efficacy and safety outcomes similar to those in a non-Japanese patient population. |
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| المشرفين على المادة: | 0 (Recombinant Fusion Proteins) 15C2VL427D (aflibercept) EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor) |
| تواريخ الأحداث: | Date Created: 20180223 Date Completed: 20200629 Latest Revision: 20200629 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC6510325 |
| DOI: | 10.1097/IAE.0000000000002100 |
| PMID: | 29470308 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1539-2864 |
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| DOI: | 10.1097/IAE.0000000000002100 |