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https://www.readbyqxmd.com/read/28654629/predictors-of-one-year-visual-outcomes-after-anti-vascular-endothelial-growth-factor-treatment-for-neovascular-age-related-macular-degeneration
#1
Laurent Kodjikian, Evelyne Decullier, Eric H Souied, Adeline Roux, Gilles Aulagner, Laure Huot
PURPOSE: To determine predictors of best-corrected visual acuity (BCVA) outcomes 1 year after ranibizumab or bevacizumab treatment for neovascular age-related macular degeneration, within the French Study Group Avastin versus Lucentis for neovascular age-related macular degeneration (GEFAL). METHODS: Patients aged ≥50 years presenting subfoveal neovascular age-related macular degeneration were randomized to receive ranibizumab or bevacizumab (3 monthly intravitreal injections followed by an as-needed regimen)...
June 20, 2017: Retina
https://www.readbyqxmd.com/read/28651442/a-randomized-single-blind-phase-i-trial-invictan-1-assessing-the-bioequivalence-and-safety-of-bi-695502-a-bevacizumab-biosimilar-candidate-in-healthy-subjects
#2
Willem Hettema, Christopher Wynne, Benjamin Lang, Mario Altendorfer, Niklas Czeloth, Ragna Lohmann, Sandeep Athalye, Dorothee Schliephake
OBJECTIVES: This Phase I trial (INVICTAN(®)-1) evaluated three-way bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin(®), Genentech; EU-approved Avastin, Roche). METHODS: Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary endpoint to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early...
June 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28620705/topical-bevacizumab-treatment-in-aniridia
#3
Ruth Lapid-Gortzak, Nathalie T Y Santana, Carla P Nieuwendaal, Maarten P Mourits, Ivanka J E van der Meulen
PURPOSE: To report the results of long-term topical treatment with bevacizumab (Avastin) 5 mg/mL eyedrops in a case of aniridia-related neovacularization of the cornea. METHODS: Interventional case report. A female patient with aniridia had a decrease in the best corrected visual acuity from 0.32 to 0.02 in the OS over the course of 4 years, secondary to central corneal neovascularization and epithelial breakdown. Vision in the OD was 0.2. In 2008, at age 28, a shared decision was made to start off-label treatment with bevacizumab eyedrops 0...
June 15, 2017: International Ophthalmology
https://www.readbyqxmd.com/read/28613352/comparison-of-ranibizumab-and-bevacizumab-for-macular-edema-secondary-to-retinal-vein-occlusions-in-routine-clinical-practice
#4
Mehnaz Khan, Karen M Wai, Fabiana Q Silva, Sunil Srivastava, Justis P Ehlers, Aleksandra Rachitskaya, Amy Babiuch, Ryan Deasy, Peter K Kaiser, Andrew P Schachat, Alex Yuan, Rishi P Singh
BACKGROUND AND OBJECTIVE: To determine outcomes of intravitreal ranibizumab (IVR) (Lucentis; Genentech, South San Francisco, CA) versus bevacizumab (IVB) (Avastin; Genentech, South San Francisco, CA) for treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) in routine clinical practice. PATIENTS AND METHODS: A retrospective study identified treatment-naïve patients with ME secondary to RVO where treatment with either IVB or IVR was initiated...
June 1, 2017: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/28594907/gastrointestinal-cancer-cells-treatment-with-bevacizumab-activates-a-vegf-autoregulatory-mechanism-involving-telomerase-catalytic-subunit-htert-via-pi3k-akt-hif-1%C3%AE-and-vegf-receptors
#5
Nadine Mahfouz, Roula Tahtouh, Nada Alaaeddine, Joelle El Hajj, Riad Sarkis, Ray Hachem, Issam Raad, George Hilal
BACKGROUND: Targeting angiogenesis has been considered a promising treatment of choice for a large number of malignancies, including gastrointestinal cancers. Bevacizumab is an anti-vascular endothelial growth factor (anti-VEGF) being used for this purpose. However, treatment efficacy is largely questioned. Telomerase activity, responsible for cancer cell immortality, is detected in 85-95% of human cancers and is considered a potential regulator of VEGF. The aim of our study was to investigate the interrelationship between VEGF and hTERT in gastrointestinal cancers and to explore cell response to a combined inhibition of telomerase and VEGF...
2017: PloS One
https://www.readbyqxmd.com/read/28591284/quality-of-bevacizumab-avastin%C3%A2-repacked-in-single-use-glass-vials-for-intravitreal-administration
#6
Michelle A A Sugimoto, Vicente de Paulo Coelho Peixoto de Toledo, Mariem Rodrigues Ribeiro Cunha, Virginia M Carregal, Rodrigo Jorge, Pedro Leão, Sílvia Ligorio Fialho, Armando Silva-Cunha
Purpose: Avastin® (bevacizumab) is an anti-vascular endothelial growth factor (VEGF) monoclonal antibody given as an off-label drug by intravitreal administration for treatment of ocular diseases. The drug's clinical application and its cost-benefit profile has generated demand for its division into single-use vials to meet the low volume and low-cost doses necessary for intraocular administration. However, the safety of compounding the drug in single-use vials is still under discussion...
March 2017: Arquivos Brasileiros de Oftalmologia
https://www.readbyqxmd.com/read/28515673/growth-of-mcf-7-breast-cancer-cells-and-efficacy-of-anti-angiogenic-agents-in-a-hydroxyethyl-chitosan-glycidyl-methacrylate-hydrogel
#7
Hejing Wang, Junmin Qian, Yaping Zhang, Weijun Xu, Juxiang Xiao, Aili Suo
BACKGROUND: Breast cancer negatively affects women's health worldwide. The tumour microenvironment plays a critical role in tumour initiation, proliferation, and metastasis. Cancer cells are traditionally grown in two-dimensional (2D) cultures as monolayers on a flat solid surface lacking cell-cell and cell-matrix interactions. These experimental conditions deviate from the clinical situation. Improved experimental systems that can mimic the in vivo situation are required to discover new therapies, particularly for anti-angiogenic agents that mainly target intercellular factors and play an essential role in treating some cancers...
2017: Cancer Cell International
https://www.readbyqxmd.com/read/28458922/bevacizumab-avastin-and-thermal-laser-combination-therapy-for-peripapillary-choroidal-neovascular-membranes
#8
Sean D Adrean, Scott Grant, Siyang Chaili
Objective. This is a retrospective interventional case series describing the results of 5 eyes from 5 patients with symptomatic peripapillary choroidal neovascularization (CNVM) receiving initial bevacizumab treatment followed by thermal laser and bevacizumab combination therapy. Methods. Patients received intravitreal bevacizumab injections until the lesions were well-defined. Thermal laser ablation was then administered and followed by an additional bevacizumab injection after one week. Visual outcomes, OCT changes, and rates of recurrence were recorded and analyzed...
2017: Journal of Ophthalmology
https://www.readbyqxmd.com/read/28413496/clinical-observation-of-the-efficacy-of-bevacizumab-combined-with-argon-green-laser-in-treating-fundus-macular-edema
#9
Yi Shao, Yao Yu, Cheng Li, Chong-Gang Pei, Ping Tu, Yun Han, Gui-Ping Gao
We studied the clinical efficacy of Bevacizumab combined with argon green laser in treating fundus macular edema. From May 2009 to April 2013, 78 patients seeking treatment for macular edema in the First Affiliated Hospital of Nanchang University were enrolled in this study. Patients were randomly divided into two groups: i) The experimental group (n=39) and the control group (n=39). Patients in the experimental group were treated with Bevacizumab (Avastin(®)) combined with argon green laser, and those in the control group were treated exclusively with argon green laser...
April 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/28409646/intravitreal-bevacizumab-alters-type-iv-collagenases-and-exacerbates-arrested-alveologenesis-in-the-neonatal-rat-lungs
#10
Arwin M Valencia, Charles L Cai, Jeffrey Tan, Thomas J Duggan, Gloria B Valencia, Jacob V Aranda, Kay D Beharry
Purpose/Aim: Intravitreal bevacizumab (Avastin) is an irreversible vascular endothelial growth factor (VEGF) inhibitor used off-label to treat severe retinopathy of prematurity in extremely low gestational age neonates. VEGF and matrix metalloproteinases (MMPs) and the tissue inhibitors of metalloproteinases (TIMPs) participate in lung maturation. We tested the hypothesis that intravitreal bevacizumab enters the systemic circulation and has long-lasting effects on lung MMPs. MATERIALS AND METHODS: Neonatal rats were exposed to: (1) hyperoxia (50% O2); (2) intermittent hypoxia (IH) (50% O2 with brief episodes of 12% O2); or (3) room air (RA) from birth (P0) to P14...
April 2017: Experimental Lung Research
https://www.readbyqxmd.com/read/28357118/a-phase-1-study-comparing-the-proposed-biosimilar-bs-503a-with-bevacizumab-in-healthy-male-volunteers
#11
Naoyuki Tajima, Alberto Martinez, Fumiaki Kobayashi, Ling He, Peter Dewland
This is a randomized, double-blind, single-dose, parallel group phase 1 study to assess pharmacokinetic similarity, safety, and tolerability of BS-503a, a proposed bevacizumab biosimilar. A total of 114 male healthy subjects were randomized (1:1) to receive a single 3 mg/kg intravenous dose of either BS-503a or bevacizumab (Avastin(®)). Pharmacokinetic (PK) blood samples were collected up to Day 78, and serum drug concentrations were measured using a validated enzyme-linked immunosorbent assay. Pharmacokinetic similarity was evaluated using area under the serum concentration-time curve from zero to infinity (AUC inf) as a primary PK parameter, and maximum serum concentration (Cmax) and area under the serum concentration-time curve from zero to the last measurable time (AUC last) as secondary PK parameters...
April 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28301412/large-silicone-droplets-after-intravitreal-bevacizumab-avastin
#12
Robert L Avery, Alessandro A Castellarin, Dilsher S Dhoot, Dante J Pieramici, Maʼan A Nasir, Nathan C Steinle, Logan P Avery, Gabriel M Gordon
PURPOSE: Despite its off-label status, intravitreal bevacizumab is the most commonly used intraocular anti-vascular endothelial growth factor agent. Regulation of compounding pharmacies has recently increased to make compounded pharmaceuticals safer. Despite these changes, a marked increase in symptomatic, large silicone oil droplets following intravitreal bevacizumab injections was noticed. METHODS: Retrospective chart review was performed. Within a single private practice, patients who were noted to have large or symptomatic silicone oil bubbles after an intravitreal injection were reviewed...
March 15, 2017: Retinal Cases & Brief Reports
https://www.readbyqxmd.com/read/28297041/fluorescein-angiography-versus-optical-coherence-tomography-angiography-in-macular-telangiectasia-type-i-treated-with-bevacizumab-therapy
#13
Nicolas A Yannuzzi, Ninel Z Gregori, Luiz Roisman, Nisha Gupta, Brian E Goldhagen, Raquel Goldhardt
This is a report of microvascular changes seen on fluorescein angiography (FA) and optical coherence tomography angiography (OCTA) in a 47-year-old man with macular telangiectasia Type 1 (MacTel1) after a 7-year bevacizumab (Avastin; Genentech, South San Francisco, CA) treatment course. OCTA allowed for clear visualization of most telangiectasias and aneurysms in the deep capillary plexus, with only few microvascular dilatations in the superficial plexus. In addition, areas of capillary dropout in the superficial and deep vascular plexa located near telangiectasias were documented on OCTA...
March 1, 2017: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/28297035/short-term-effects-of-early-switching-to-ranibizumab-or-aflibercept-in-diabetic-macular-edema-cases-with-non-response-to-bevacizumab
#14
Mohammed Ashraf, Ahmed A R Souka, Hassan ElKayal
BACKGROUND AND OBJECTIVES: To study the effect of early switching to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in cases of diabetic macular edema (DME) that have shown no response to bevacizumab (Avastin; Genentech, South San Francisco, CA). PATIENTS AND METHODS: A retrospective study involving 59 eyes of 45 patients with DME previously treated with bevacizumab. Patients were switched either to ranibizumab or aflibercept...
March 1, 2017: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/28294622/tracking-antibody-distribution-with-near-infrared-fluorescent-dyes-impact-of-dye-structure-and-degree-of-labeling-on-plasma-clearance
#15
Cornelius Cilliers, Ian Nessler, Nikolas Christodolu, Greg M Thurber
Monoclonal antibodies labeled with near-infrared (NIR) fluorophores have potential use in disease detection, intraoperative imaging, and pharmacokinetic characterization of therapeutic antibodies in both the preclinical and clinical setting. Recent work has shown conjugation of NIR fluorophores to antibodies can potentially alter antibody disposition at a sufficiently high degree of labeling (DoL); however, other reports show minimal impact after labeling with NIR fluorophores. In this work, we label two clinically approved antibodies, Herceptin (trastuzumab) and Avastin (bevacizumab), with NIR dyes IRDye 800CW (800CW) or Alexa Fluor 680 (AF680), at 1...
May 1, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28256268/antiangiogenic-activity-of-a-bevacizumab-loaded-polyurethane-device-in-animal-neovascularization-models
#16
A E R Ferreira, B F M Castro, L C Vieira, G D Cassali, C M Souza, G O Fulgêncio, E Ayres, R L Oréfice, R Jorge, A Silva-Cunha, S L Fialho
PURPOSE: To evaluate the antiangiogenic activity of bevacizumab-loaded polyurethane using two animal models of neovascularization. METHODS: The percentage of blood vessels was evaluated in a chicken chorioallantoic membrane model (n=42) and in the rabbit cornea (n=24) with neovascularization induced by alkali injury. In each model, the animals were randomly divided into the groups treated with the bevacizumab-loaded polyurethane device, phosphate-buffered-saline (negative control) and bevacizumab commercial solution (positive control)...
March 2017: Journal Français D'ophtalmologie
https://www.readbyqxmd.com/read/28238523/posterior-reversible-encephalopathy-syndrome-pres-with-sub-arachnoid-haemorrhage-after-bevacizumab-and-5-fu
#17
Jennifer Massey
PRES is a neurological syndrome characterised by reversible subcortical vasogenic brain oedema in patients with acute neurological signs and symptoms. It occurs in the context of fluctuations in blood pressure, renal failure, autoimmune disorders, eclamptic syndromes and with use of cytotoxic drugs. We present the case of a 60year old female with advanced bowel cancer who was admitted with seizures and sub-arachnoid haemorrhage, with radiographic features of PRES, shortly after receiving bevacizumab (Avastin), a VEGF-inhibitor...
February 23, 2017: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
https://www.readbyqxmd.com/read/28194878/platelet-activated-serum-might-have-a-therapeutic-effect-on-damaged-articular-cartilage
#18
Munetaka Yokoyama, Masato Sato, Yoshiki Tani, Miyuki Yokoyama, Mami Kokubo, Masayuki Yamato, Teruo Okano, Joji Mochida
Platelet-activated serum (PAS) was collected from rabbits. This contains high concentrations of growth factors, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF)-BB, and transforming growth factor-beta (TGF-β). PAS was injected into the knee joints of Japanese White rabbits subjected to anterior cruciate ligament transection (ACL-T) to investigate its therapeutic effects on articular cartilage. The effect of Avastin (an anti-VEGF monoclonal antibody) on VEGF expression was also investigated...
February 14, 2017: Journal of Tissue Engineering and Regenerative Medicine
https://www.readbyqxmd.com/read/28193603/roche-asks-who-to-remove-avastin-from-essential-medicines-list
#19
Deborah Cohen
No abstract text is available yet for this article.
February 13, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28117563/patent-law-s-reproducibility-paradox
#20
Jacob S Sherkow
Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible--their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but also legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine hamper or even actively dissuade reproducible data in patents...
January 2017: Duke Law Journal
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