The study employed a multicenter, randomized, sham - controlled, single masked design.  (Clinical Trial), A Multicenter, Randomized, Sham-control, Proof-of-concept Study of Intravitreal LFG316 in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration, 55 Years and older   (Adult, Older Adult), Tucson, Arizona, United States, 85704-5614, Beverly Hills, California, United States, 90211, Pasadena, California, United States, 91105-3153, Sacramento, California, United States, 95841, Colorado Springs, Colorado, United States, 80909, Fort Myers, Florida, United States, 33912-7125, Winter Haven, Florida, United States, 33880, Boston, Massachusetts, United States, 02114, Grand Rapids, Michigan, United States, 49546, Charlotte, North Carolina, United States, 28210, Silverdale, Washington, United States, 98383. 12 Novartis Q1 Results | April 28, 2020 | Novartis Investor Presentation As of April 24, 2020 1. Available online at: https://ClinicalTrials.gov/show/ NCT01527500 (accessed November 19, 2018). ... " Complement Inhibition with the C5 Blocker LFG316 in Severe COVID-19." The defense system consists of retinal innate immune cells (including microglia, perivascular macrophages, and a small population of dendritic cells) and the complement system. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. Principal Investigator: C. Stephen Foster, M.D., F.A.C.S., F.A.C.R. Known or suspected hereditary complement deficiency Talk with your doctor and family members or friends about deciding to join a study. Severe concurrent co-morbidities that are a likely caused by underlying autoimmune diseases other than PNH Certain conditions will exclude patients from this study, such as specific medications and endophthalmitis. This site uses cookies. “A couple of patients with intraocular inflammation and a few patients with raised IOP were similar to [the rates] we’ve seen previously with intravitreal injections,” Zamiri said. x. Cmax usually happens within a few hours after the dose is taken. For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Cardiff University, 2112, Division of Infection and Immunity, Cardiff, United Kingdom of Great Britain and Northern Ireland; Complement Inhibition with the C5 Blocker LFG316 in Severe COVID-19. Male and female patients between the age of 18-75 (inclusive), or 18-65 (applicable in Czech Republic) with a diagnosis of PNH prior to screening This study examines the effect of intravitreal LFG316 on patients with active non-infectious uveitis. Complement activation in the retina is an important part of chronic inflammation and may contribute to retinal pathology in these disease states. Targeting the complement system for the management of retinal inflammatory and degenerative diseases. LFG316 is a C5-specific mAb developed by Novartis. This site complies with the HONcode standard for trustworthy health information: verify here. Mean change in GA lesion growth from baseline to Day 169 and Day 505. This site is intended for a global audience. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). “LFG316 has an acceptable safety profile ... for further development, but monthly treatment with LFG316 monotherapy was not efficacious, ... Zamiri reports she is a consultant for Novartis. Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set), n=number of participants, h=hours after the last administered dose e.g. Novartis Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD). 40 A phase 2 study of intravitreal LFG316 has been completed in patients with neovascular age-related macular degeneration, but the results have yet to be published (NCT01535950). If the mean concentration is 0.00, that means there is no drug in the bloodstream, n=number of participants, h=scheduled sampling time, PART B: Tmax (Time of Maximum concentration observed). Maxitrol® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) Prescribing Information. With currently more than 100 distinct drugs in research and development, MorphoSys has one of the broadest pipelines in the biotechnology industry, including unique approaches that aim to help patients with conditions such as cancer, Alzheimer’s disease, infectious diseases, cardiovascular dysfunction and … Get the latest research information from NIH: You have reached the maximum number of saved studies (100). It is in phase 2 clinical trials for a number of complement related diseases, including Paroxysmal nocturnal hemoglobinuria (PNH), AMD, and non-infectious uveitis. Standard ophthalmic exams are part of each exam (about once a month). COVID-19 is an emerging, rapidly evolving situation. Read our, ClinicalTrials.gov Identifier: NCT01527500, Interventional An Open-label Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316, an Anti-C5 Monoclonal Antibody in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) 2.4 LFG316 (Novartis) A proof‐of‐concept phase I study is currently investigating LFG316 in untreated PNH patients in Japan (NCT02534909); the primary endpoint of the study is biological efficacy, as measured by LDH change.

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