Comparing the Effectiveness of Bevacizumab to Ranibizumab in Patients with Exudative Age-Related Macular Degeneration. The BRAMD Study
| Autor: | Marcel G. W. Dijkgraaf, Tunde Peto, Greet Dijkman, F. D. Verbraak, Johanna M. M. Hooymans, Reinier O. Schlingemann, Carel B. Hoyng, Johannes R. Vingerling, Ann-Sofie M E Schauwvlieghe |
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| Přispěvatelé: | Netherlands Institute for Neuroscience (NIN), ANS - Cellular & Molecular Mechanisms, Ophthalmology, Biomedical Engineering and Physics, Clinical Research Unit, Epidemiology |
| Rok vydání: | 2016 |
| Předmět: |
PHARMACOKINETICS
Visual acuity genetic structures Physiology Vision Visual Acuity Social Sciences lcsh:Medicine Infographics Sensory disorders Donders Center for Medical Neuroscience [Radboudumc 12] law.invention Macular Degeneration 0302 clinical medicine Randomized controlled trial law Medicine and Health Sciences Psychology Geriatric Ophthalmology lcsh:Science Multidisciplinary Pharmaceutics Research Support Non-U.S. Gov't Retinal Degeneration Middle Aged Charts Body Fluids Multicenter Study Bevacizumab Choroidal neovascularization Treatment Outcome Research Design Randomized Controlled Trial Physical Sciences Retinal Disorders Sensory Perception TRIAL medicine.symptom Anatomy Statistics (Mathematics) medicine.drug Research Article medicine.medical_specialty Computer and Information Sciences Clinical Research Design Research and Analysis Methods 03 medical and health sciences Drug Therapy Double-Blind Method Ocular System Ophthalmology Ranibizumab Journal Article medicine Confidence Intervals Humans Comparative Study Aged Intention-to-treat analysis business.industry Data Visualization lcsh:R Biology and Life Sciences Macular degeneration medicine.disease Confidence interval eye diseases Vitreous Body Geriatrics Macular Disorders 030221 ophthalmology & optometry Wet Macular Degeneration Eyes lcsh:Q Adverse Events sense organs business Head 030217 neurology & neurosurgery Mathematics Neuroscience |
| Zdroj: | PLoS One, 11, 5 PLoS ONE, Vol 11, Iss 5, p e0153052 (2016) PLoS ONE PLoS One, 11(5). Public Library of Science PLoS ONE, 11(5). Public Library of Science PLoS One (print), 11(5):e0153052. Public Library of Science PLoS ONE, 11(5):e0153052. PUBLIC LIBRARY SCIENCE PLoS One, 11 PLoS ONE, 11(5) Schauwvlieghe, A M E, Dijkman, G, Hooymans, J M, Verbraak, F D, Hoyng, C B, Dijkgraaf, M G W, Peto, T, Vingerling, J R & Schlingemann, R O 2016, ' Comparing the Effectiveness of Bevacizumab to Ranibizumab in Patients with Exudative Age-Related Macular Degeneration. The BRAMD Study ' PloS one, vol. 11, no. 5, pp. e0153052 . DOI: 10.1371/journal.pone.0153052 |
| ISSN: | 1932-6203 |
| Popis: | Contains fulltext : 167677.PDF (Publisher’s version ) (Open Access) PURPOSE: To compare the effectiveness of bevacizumab and ranibizumab in the treatment of exudative age-related macular degeneration (AMD). DESIGN: Multicentre, randomized, controlled, double-masked clinical trial in 327 patients. The non-inferiority margin was 4 letters. PATIENTS: Patients >/= 60 years of age with primary or recurrent sub- or juxtafoveal choroidal neovascularization (CNV) secondary to AMD with a total area of CNV < 12 disc areas and a best corrected visual acuity (BCVA) score between 20 and 78 letters on an EDTRS like chart in the study eye. METHODS: Monthly intravitreal injections with 1.25 mg bevacizumab or 0.5 mg ranibizumab were given during one year. Intention to treat with last observation carried forward analysis was performed. MAIN OUTCOME MEASURES: Primary outcome was the change in BCVA in the study eye from baseline to 12 months. RESULTS: The mean gain in BCVA was 5.1 (+/-14.1) letters in the bevacizumab group (n = 161) and 6.4 (+/-12.2) letters in the ranibizumab group (n = 166) (p = 0.37). The lower limit of the 95% confidence interval of the difference in BCVA gain was 3.72. The response to bevacizumab was more varied; 24% of patients showed a gain of >/=15 letters, 11% a loss of >/=15 letters and 65% a gain or loss < 15 letters compared to 19%, 5% and 76% respectively for ranibizumab (p = 0.038). No significant differences in absolute CRT and CRT change (p = 0.13) or in the presence of subretinal or intraretinal fluid (p = 0.14 and 0.10, respectively) were observed. However, the presence of any fluid on SD-OCT (subretinal and/or intraretinal) differed significantly (p = 0.020), with definite fluid on SD-OCT in 45% of the patients for bevacizumab versus 31% for ranibizumab. The occurrence of serious adverse events and adverse events was similar, with 34 SAEs and 256 AEs in the bevacizumab group and 37 SAEs and 299 AEs in the ranibizumab group (p = 0.87 and p = 0.48, respectively). CONCLUSIONS: Bevacizumab was not inferior to ranibizumab. The response to bevacizumab was more varied with higher percentages of both gainers and losers and more frequently observed retinal fluid on SD-OCT at 12 months when compared to the ranibizumab group. TRIAL REGISTRATION: Trialregister.nl NTR1704. |
| Databáze: | OpenAIRE |
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