دورية أكاديمية
Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration.
| العنوان: | Randomized Phase IIb Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-Related Macular Degeneration. |
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| المؤلفون: | Freeman WR; Jacobs Retina Center, University of California San Diego, La Jolla, California. Electronic address: wrfreeman@health.ucsd.edu., Bandello F; Department of Ophthalmology, University Vita-Salute Scientific Institute, Hospital San Raffaele, Milan, Italy., Souied E; Centre Hospitalier Creteil, Service Universitaire d'Ophthalmologie, Creteil, France., Guymer RH; Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, and Department of Surgery (Ophthalmology), University of Melbourne, Melbourne, Australia., Garg SJ; Mid Atlantic Retina, the Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania., Chen FK; Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, and Department of Surgery (Ophthalmology), University of Melbourne, Melbourne, Australia; Centre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), the University of Western Australia, Nedlands, Western Australia, Australia., Rich R; Retina Consultants of Southern Colorado PC, Colorado Springs, Colorado., Holz FG; Department of Ophthalmology, University of Bonn, Bonn, Germany., Patel SS; West Texas Retina, Abilene, Texas., Kim K; Data and Statistical Sciences, Allergan, an AbbVie company, Irvine, California., López FJ; Eye Care Development, Allergan, an AbbVie company, Irvine, California. |
| مؤلفون مشاركون: | BEACON Study Group |
| المصدر: | Ophthalmology. Retina [Ophthalmol Retina] 2023 Jul; Vol. 7 (7), pp. 573-585. Date of Electronic Publication: 2023 Mar 10. |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase II; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Published by Elsevier Inc. on behalf of American Academy of Ophthalmology Country of Publication: United States NLM ID: 101695048 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2468-6530 (Electronic) Linking ISSN: 24686530 NLM ISO Abbreviation: Ophthalmol Retina Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Published by Elsevier Inc. on behalf of American Academy of Ophthalmology, [2017]- |
| مواضيع طبية MeSH: | Geographic Atrophy*/diagnosis , Geographic Atrophy*/drug therapy , Geographic Atrophy*/etiology , Macular Degeneration*/complications , Macular Degeneration*/diagnosis , Macular Degeneration*/drug therapy, Humans ; Retina ; Drug Delivery Systems/adverse effects ; Intravitreal Injections |
| مستخلص: | Purpose: To evaluate the safety and efficacy of repeat injections of Brimonidine Drug Delivery System (Brimo DDS) Generation 2 (Gen 2) containing 400-μg brimonidine in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Design: A phase IIb, randomized, multicenter, double-masked, sham-controlled, 30-month study (BEACON). Participants: Patients diagnosed with GA secondary to AMD and multifocal lesions with total area of > 1.25 mm 2 and ≤ 18 mm 2 in the study eye. Methods: Enrolled patients were randomized to treatment with intravitreal injections of 400-μg Brimo DDS (n = 154) or sham procedure (n = 156) in the study eye every 3 months from day 1 to month 21. Main Outcome Measures: The primary efficacy endpoint was GA lesion area change from baseline in the study eye, assessed with fundus autofluorescence imaging, at month 24. Results: The study was terminated early, at the time of the planned interim analysis, because of a slow GA progression rate (∼ 1.6 mm 2 /year) in the enrolled population. Least squares mean (standard error) GA area change from baseline at month 24 (primary endpoint) was 3.24 (0.13) mm 2 with Brimo DDS (n = 84) versus 3.48 (0.13) mm 2 with sham (n = 91), a reduction of 0.25 mm 2 (7%) with Brimo DDS compared with sham (P = 0.150). At month 30, GA area change from baseline was 4.09 (0.15) mm 2 with Brimo DDS (n = 49) versus 4.52 (0.15) mm 2 with sham (n = 46), a reduction of 0.43 mm 2 (10%) with Brimo DDS compared with sham (P = 0.033). Exploratory analysis showed numerically smaller loss over time in retinal sensitivity assessed with scotopic microperimetry with Brimo DDS than with sham (P = 0.053 at month 24). Treatment-related adverse events were usually related to the injection procedure. No implant accumulation was observed. Conclusions: Multiple intravitreal administrations of Brimo DDS (Gen 2) were well tolerated. The primary efficacy endpoint at 24 months was not met, but there was a numeric trend for reduction in GA progression at 24 months compared with sham treatment. The study was terminated early because of the lower-than-expected GA progression rate in the sham/control group. Financial Disclosure(s): Proprietary or commercial disclosures may be found after the references. (Copyright © 2023 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Investigator: F Chen; R Guymer; JF Korobelnik; E Souied; F Holz; F Ziemssen; F Bandello; E Campos; C GrignoloEandi; E Midena; E Peiretti; G Staurenghi; F Viola; C Bailey; SD Esposti; T Jackson; G Menon; S Pagliarini; F Quhill; A Antoszyk; L Brooks; D Callanan; K Csaky; A Edwards; D Eichenbaum; W Freeman; S Garg; AT Ghuman; V Gonzalez; S Gupta; R Hamilton; R Khurana; D Kunimoto; B Kuppermann; A Lauer; SY Lee; R Maturi; S Patel; R Reddy; R Rich; M Rivellese; S Rose; Z Segal; R Wong Keywords: Age-related macular degeneration; Brimonidine; Geographic atrophy; Implant; Nonexudative |
| تواريخ الأحداث: | Date Created: 20230311 Date Completed: 20230710 Latest Revision: 20231116 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.oret.2023.03.001 |
| PMID: | 36906177 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2468-6530 |
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| DOI: | 10.1016/j.oret.2023.03.001 |