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Steven A Giannos, Edward R Kraft, Zhen-Yang Zhao, Kevin H Merkley, Jiyang Cai
PURPOSE: Studies were conducted to investigate dilute solutions of the monoclonal antibody (mAb) bevacizumab, mAb fragment ranibizumab and fusion protein aflibercept, develop common procedures for formulation of low concentration mAbs and identify a stabilizing formulation for anti-VEGF mAbs for use in in vitro permeation studies. METHODS: Excipient substitutions were screened. The most stabilizing formulation was chosen. Standard dilutions of bevacizumab, ranibizumab and aflibercept were prepared in PBS, manufacturer's formulation, and the new formulation...
February 28, 2018: Pharmaceutical Research
Aljoscha S Neubauer, Christos Haritoglou, Michael W Ulbig
BACKGROUND: In the treatment of center-involving diabetic macular edema, despite initial therapy with an anti-VEGF compound, an insufficient response may occur. Further therapy options include a switch of anti-VEGF products or to corticosteroid implants, such as Fluocinolone acetonide or Dexamethasone. OBJECTIVES: Firstly, to investigate systematically which evidence-based study data are available describing the efficacy of in-label treatments after primary anti-VEGF treatment, secondly, to investigate which costs go along for the healthcare provider...
February 16, 2018: Klinische Monatsblätter Für Augenheilkunde
David M Brown, William C Ou, Tien P Wong, Rosa Y Kim, Daniel E Croft, Charles C Wykoff
PURPOSE: To evaluate the effect of targeted retinal photocoagulation (TRP) on visual and anatomic outcomes and treatment burden in eyes with diabetic macular edema (DME). DESIGN: Phase I/II prospective, randomized, controlled clinical trial. PARTICIPANTS: Forty eyes of 29 patients with center-involved macular edema secondary to diabetes mellitus. METHODS: Eyes with center-involved DME and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/32 and 20/320 (Snellen equivalent) were randomized 1:1 to monotherapy with 0...
January 11, 2018: Ophthalmology
Edward H Wood, Ryan J Whitted, Thomas W Stone, Ricky D Isernhagen, William J Wood, Diana M Holcomb, John W Kitchens
BACKGROUND AND OBJECTIVE: Ranibizumab (Lucentis; Genentech, South San Francisco, CA) is used off-label for the treatment of choroidal neovascularization secondary to ocular histoplasmosis syndrome (OHS). This study prospectively evaluates the safety and efficacy of two treatment paradigms utilizing ranibizumab 0.5 mg: one or three initial injections followed by monthly visits with PRN treatment through Month 12. PATIENTS AND METHODS: In this prospective, open-label study, 21 subjects were evaluated monthly and retreated during the pro re nata treatment phase if specific criteria were met, including loss of vision, increase in subretinal fluid, or hemorrhage...
January 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
Elena Lucenti, Alessandra Forni, Chiara Botta, Lucia Carlucci, Clelia Giannini, Daniele Marinotto, Alessandro Pavanello, Andrea Previtali, Stefania Righetto, Elena Cariati
The performance of solid luminogens depends on both their inherent electronic properties and their packing status. Intermolecular interactions have been exploited to achieve persistent room-temperature phosphorescence (RTP) from organic molecules. However, the design of organic materials with bright RTP and the rationalization of the role of interchromophoric electronic coupling remain challenging tasks. Cyclic triimidazole has been shown to be a promising scaffold for such purposes owing to its crystallization-induced room-temperature ultralong phosphorescence (RTUP), which has been associated with H-aggregation...
December 18, 2017: Angewandte Chemie
Svetlana N Tultseva, Yury S Astakhov, Sergei A Novikov, Pavel A Nechiporenko, Alla B Lisochkina, Andranik Y Ovnanyan, Sergei Y Astakhov
Purpose: We compared the efficacy and safety of ranibizumab versus ranibizumab plus scatter laser photocoagulation (SLP) in patients with chronic post-central retinal vein occlusion (CRVO) macular edema (ME). Methods: This prospective non-randomized pilot study included 250 patients with peripheral retinal ischemia and CRVO-related ME. The mean follow-up period was 24.5 ± 6.5 months. The clinical assessments conducted included best corrected visual acuity, optical coherence tomography, and multi-field fluorescein angiography with measurement of the ischemic area...
July 2017: Arquivos Brasileiros de Oftalmologia
Farid Menaa, Barkat Ali Khan, Bushra Uzair, Abder Menaa
Sickle cell retinopathy (SCR) is the most representative ophthalmologic complication of sickle cell disease (SCD), a hemoglobinopathy affecting both adults and children. SCR presents a wide spectrum of manifestations and may even lead to irreversible vision loss if not properly diagnosed and treated at the earliest. Over the past decade, multidisciplinary research developments have focused upon systemic, genetic, and ocular risk factors of SCR, enabling the clinician to better diagnose and manage these patients...
2017: Journal of Multidisciplinary Healthcare
François Griaud, Andrej Winter, Blandine Denefeld, Manuel Lang, Héloïse Hensinger, Frank Straube, Mirko Sackewitz, Matthias Berg
Patent expiration of first-generation biologics and the high cost of innovative biologics are 2 drivers for the development of biosimilar products. There are, however, technical challenges to the production of exact copies of such large molecules. In this study, we performed a head-to-head comparison between the originator anti-VEGF-A Fab product LUCENTIS® (ranibizumab) and an intended copy product using an integrated analytical approach. While no differences could be observed using size-exclusion chromatography, capillary electrophoresis-sodium dodecyl sulfate and potency assays, different acidic peaks were identified with cation ion exchange chromatography and capillary zone electrophoresis...
November 2017: MAbs
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No abstract text is available yet for this article.
August 2017: Eye
E Cariati, X Liu, Y Geng, A Forni, E Lucenti, S Righetto, S Decurtins, S-X Liu
The second-order nonlinear optical (NLO) properties of two tetrathiafulvalene (TTF)-fused electron donor-acceptor dyads have been determined using the Electric Field Induced Second Harmonic generation (EFISH) technique and theoretically rationalized. Dyads TTF-dppz (1) and TTF-BTD (2) were obtained by direct fusion of a TTF electron donor unit either with a dipyrido[3,2-a:2',3'-c]phenazine (dppz) or a benzothiadiazole (BTD) electron acceptor moiety. Dyad 1 acts as a reversible acido-triggered NLO switch by protonation/deprotonation at two nitrogen atoms of the dppz acceptor moiety induced by sequential exposure to HCl and ammonia vapors...
August 23, 2017: Physical Chemistry Chemical Physics: PCCP
Rui-Hong Ju, Man-Sha He, Jin-Tong Hou, Meng-Yuan Li, Jing-Lin Zhang, Zhe-Ming Wu
OBJECTIVE: To evaluate the changes in retinal functions using multifocal electroretinography (mfERG) following intravitreal injection of Lucentis for treatment of wet age-related macular degeneration. METHODS: This prospective study was conducted in 14 patients (9 men and 5 women, 14 eyes) with wet age-related macular degeneration receiving treatment with intravitreal injections of ranibizumab (Lucentis) in our hospital between October, 2014 and January, 2016. All the patients received the treatment following a 1+PRN protocol and after the initial injection, the patients were followed up monthly for 6 months to decide if additional injections were needed...
July 20, 2017: Nan Fang Yi Ke da Xue Xue Bao, Journal of Southern Medical University
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
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
Ana R Santos, Miguel  Costa, Christian Schwartz, Dalila Alves, João Figueira, Rufino Silva, Jose G Cunha-Vaz
PURPOSE: To identify baseline optical coherence tomography morphologic characteristics predicting the visual response to anti-vascular endothelial growth factor therapy in diabetic macular edema. METHODS: Sixty-seven patients with diabetic macular edema completed a prospective, observational study (NCT01947881-CHARTRES). All patients received monthly intravitreal injections of Lucentis for 3 months followed by PRN treatment and underwent best-corrected visual acuity measurements and spectral domain optical coherence tomography at Baseline, Months 1, 2, 3, and 6...
May 2, 2017: Retina
Dilraj S Grewal, Tayler Schwartz, Sharon Fekrat
The authors report the unique response of two patients treated for cystoid macular edema (CME) secondary to central retinal vein occlusion (CRVO) who developed sequential episodes of likely sterile inflammatory responses following separate intravitreal injections of aflibercept (Eylea; Regeneron, Tarrytown, NY) and ranibizumab (Lucentis; Genentech, South San Francisco, CA) despite multiple previous uneventful injections for CME secondary to CRVO. Following the twenty-fifth aflibercept and seventh ranibizumab injection, two patients developed an acute inflammatory response, which was treated empirically with intravitreal antibiotics and topical and oral steroids (in Case 2)...
May 1, 2017: Ophthalmic Surgery, Lasers & Imaging Retina
O Comyn, L Wickham, D G Charteris, P M Sullivan, E Ezra, Z Gregor, G W Aylward, L da Cruz, D Fabinyi, T Peto, M Restori, W Xing, C Bunce, P G Hykin, J W Bainbridge
PurposeOur aim was to evaluate the impact of intravitreal ranibizumab pretreatment on the outcome of vitrectomy surgery for advanced proliferative diabetic retinopathy. The objective was to determine the feasibility of a subsequent definitive trial and estimate the effect size and variability of the outcome measure.Patients and methodsWe performed a pilot randomised double-masked single-centre clinical trial in 30 participants with tractional retinal detachment associated with proliferative diabetic retinopathy...
September 2017: Eye
Faegheh Rezaie, Fatemeh Davami, Kamran Mansouri, Sulmaz Agha Amiri, Ramin Fazel, Reza Mahdian, Noushin Davoudi, Somayeh Enayati, Mohammad Azizi, Vahid Khalaj
AIMS: The E. coli expression system is highly effective in producing recombinant proteins. However, there are some limitations in this system, especially in obtaining correctly folded forms of some complex proteins such as Fab fragments. To improve the solubility and folding quality of Fab fragments, we have examined the effect of simultaneous application of a SUMO fusion tag, EnBase(®) cultivation mode and a redox mutant strain in the E. coli expression system. METHODS AND RESULTS: A bicistronic gene construct was designed to express an anti-VEGF Fab fragment as a model system...
May 8, 2017: Journal of Applied Microbiology
Donald R Nixon, Nicholas Ap Flinn
PURPOSE: This study evaluated visual function and anatomic and vision-related quality-of-life outcomes in recalcitrant neovascular age-related macular degeneration (AMD) subjects switched to aflibercept (Eylea(®)) from ranibizumab (Lucentis(®)). METHODS: In a single-center study conducted in Barrie, ON, 40 patients with persistent fluid despite previous ranibizumab treatment were switched to aflibercept with 3 consecutive monthly doses. Main outcome measure was mean change from baseline to week 12 in Pelli-Robson contrast sensitivity (CS)...
2017: Clinical Ophthalmology
Moritz Vollrath, Julia Engert, Gerhard Winter
Solid lipid implants (SLIs) prepared by twin-screw (tsc) extrusion represent a promising technology platform for the sustained release of pharmaceutical proteins. In this work, we report on two aspects, long-term release and stability of released protein. First, SLIs were produced by tsc-extrusion containing the low melting triglyceride H12 and the high melting triglyceride Dynasan D118. Two different proteins available in a freeze-dried matrix containing hydroxypropyl-β-cyclodextrine (HP-β-CD) were incorporated into the lipid matrix: a monoclonal antibody (mAb) from the IgG1 class and the fab-fragment Ranibizumab (Lucentis(®))...
April 22, 2017: European Journal of Pharmaceutics and Biopharmaceutics
Mihaela Reinsberg, Ralf-Dieter Hilgers, Inger Lüdeke, Khaled Nassar, Swaantje Grisanti, Salvatore Grisanti, Julia Lüke, Matthias Lüke
PURPOSE: To investigate the clinical value of multifocal electroretinography (mfERG) and microperimetry and the effects of intravitreal therapy with ranibizumab (Lucentis(®)) on macular function in the course of neovascular age-related macular degeneration (nAMD). MATERIALS AND METHODS: We conducted a prospective single-arm interventional cohort study with 20 nAMD patients older than 50 years. Examinations were scheduled monthly for 1 year during intravitreal therapy with ranibizumab...
2017: Clinical Ophthalmology
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