دورية أكاديمية

A phase 2/3, multicenter, randomized, double-masked, 2-year trial of pegaptanib sodium for the treatment of diabetic macular edema.

التفاصيل البيبلوغرافية
العنوان: A phase 2/3, multicenter, randomized, double-masked, 2-year trial of pegaptanib sodium for the treatment of diabetic macular edema.
المؤلفون: Sultan MB; Pfizer Inc, New York, New York 10017, USA. marla.b.sultan@pfizer.com, Zhou D, Loftus J, Dombi T, Ice KS
مؤلفون مشاركون: Macugen 1013 Study Group
المصدر: Ophthalmology [Ophthalmology] 2011 Jun; Vol. 118 (6), pp. 1107-18. Date of Electronic Publication: 2011 May 06.
نوع المنشور: Clinical Trial, Phase II; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 7802443 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-4713 (Electronic) Linking ISSN: 01616420 NLM ISO Abbreviation: Ophthalmology Subsets: MEDLINE
أسماء مطبوعة: Publication: 2000- : New York : Elsevier
Original Publication: Rochester, Minn., American Academy of Ophthalmology.
مواضيع طبية MeSH: Aptamers, Nucleotide/*administration & dosage , Diabetic Retinopathy/*drug therapy , Macular Edema/*drug therapy, Adult ; Aged ; Aged, 80 and over ; Diabetic Retinopathy/complications ; Diabetic Retinopathy/physiopathology ; Dose-Response Relationship, Drug ; Female ; Fluorescein Angiography ; Fundus Oculi ; Humans ; Intravitreal Injections ; Macula Lutea/pathology ; Macular Edema/etiology ; Macular Edema/physiopathology ; Male ; Middle Aged ; Treatment Outcome ; Vascular Endothelial Growth Factor A ; Visual Acuity ; Young Adult
مستخلص: Purpose: To confirm the safety and compare the efficacy of intravitreal pegaptanib sodium 0.3 mg versus sham injections in subjects with diabetic macular edema (DME) involving the center of the macula associated with vision loss not due to ischemia.
Design: Randomized (1:1), sham-controlled, multicenter, parallel-group trial.
Participants: Subjects with DME.
Intervention: Subjects received pegaptanib 0.3 mg or sham injections every 6 weeks in year 1 (total = 9 injections) and could receive focal/grid photocoagulation beginning at week 18. During year 2, subjects received injections as often as every 6 weeks per prespecified criteria.
Main Outcome Measures: The primary efficacy endpoint was the proportion gaining ≥ 10 letters of visual acuity (VA) from baseline to year 1. Safety was monitored throughout.
Results: In all, 260 (pegaptanib, n = 133; sham, n = 127) and 207 (pegaptanib, n = 107; sham, n = 100) subjects were included in years 1 and 2 intent-to-treat analyses, respectively. A total of 49 of the 133 (36.8%) subjects from the pegaptanib group and 25 of the 127 (19.7%) from the sham group experienced a VA improvement of ≥ 10 letters at week 54 compared with baseline (odds ratio [OR], 2.38; 95% confidence interval, 1.32-4.30; P = 0.0047). For pegaptanib-treated subjects, change in mean VA from baseline by visit was superior (P<0.05) to sham at weeks 6, 24, 30, 36, 42, 54, 78, 84, 90, 96, and 102. At week 102, pegaptanib-treated subjects gained, on average, 6.1 letters versus 1.3 letters for sham (P<0.01). Fewer pegaptanib- than sham-treated subjects received focal/grid laser treatment (week 54, 31/133 [23.3%] vs 53/127 [41.7%], respectively, P = 0.002; week 102, 27/107 [25.2%] vs 45/100 [45.0%], respectively, P = 0.003). The pegaptanib treatment group showed significantly better results on the National Eye Institute-Visual Functioning Questionnaire than sham for subscales important in this population. Pegaptanib was well tolerated; the frequencies of discontinuations, adverse events, treatment-related adverse events, and serious adverse events were comparable in the pegaptanib and sham groups.
Conclusions: Patients with DME derive clinical benefit from treatment with the selective vascular endothelial growth factor antagonist pegaptanib 0.3 mg. These findings indicate that intravitreal pegaptanib is effective in the treatment of DME and, taken together with prior study data, support a positive safety profile in this population.
Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
(Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
فهرسة مساهمة: Investigator: A Bird; D D'Amico; J Herson; R Klein; M Wallisch; S de Gronckel; L Danielson; E Quinaz; K Wang; S Balbueno; B Mikusova; HW Spiller; P Cameron; M Sawa; S Wallace; M Altaweel; R Danis; A Domalpally; S Alexander; E Corkery; M Daywalt; K Dohm; R Endres; A Goulding; J Reimers; R Susman; H Wabers; T Whilhelmson; J White; L Lim; T Wong; P Mitchell; M Kralinger; M Stur; M Avila; M Farah; J Lavinsky; D Maberly; S Olivier; P Rosemont; J Dusova; J Ernest; I Fiser; P Kolar; J Rehak; M Larsen; JP Berrod; F Devin; F Koenig-Supiot; P Massin; G Soubrane; S Dithmar; F Holz; A Joussen; A Lappas; KU Bartz-Schmidt; G Spital; P Wiedemann; I Vergados; R Azad; S Jalali; P Murthy; M Nagpal; F Bandello; P Lanzetta; R Lattanzio; U Menchini; J Keunen; J Figueira; GM Sarra; P Trittibach; C Brand; J Talks; K Carnevale; TA Ciulla; TB Connor; D Elliott; TR Friberg; CA Garcia; VH Gonzalez; N Gross; LS Halperin; HL Hudson; G Kokame; E Lit; DM Marcus; S Patel; P Pavan; R Rosa; D Sang; D Sang; M Singer; MP Varenhorst; J Wells; AP Adamis; F Betts; K Burke; ET Cunningham; K Curtiss; M Goldbaum; DR Guyer; E Harrison; B Katz; C Liss; H Masonson; D O'Shaughnessy; R Archer; R Barbeito; R Bojko; M Borgstadt; R Carlin; P Chappell; C Cobles; J Culhane; B Davisson; M Elkins; D Eveleth; S Fernstrom; K Franklin; F Houghton; dH Edward Hume; J Hilary Jones; K Kirschner; K Kwok; P Lee; A Littel; K Lock; S Lyster; P Machado; T Maeda-Chubachi; A Maute; A Mulvaney; B O'Neill; D Paggiarino; K Quinto-Olegario; A Pleil; C Stewart; G Wilson; E Yan; M Zurlo
المشرفين على المادة: 0 (Aptamers, Nucleotide)
0 (Vascular Endothelial Growth Factor A)
2H1PA8H1EN (pegaptanib)
تواريخ الأحداث: Date Created: 20110503 Date Completed: 20110811 Latest Revision: 20220330
رمز التحديث: 20231215
DOI: 10.1016/j.ophtha.2011.02.045
PMID: 21529957
قاعدة البيانات: MEDLINE
الوصف
تدمد:1549-4713
DOI:10.1016/j.ophtha.2011.02.045