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LEVEL Study Published in British Journal of Ophthalmology Evaluates Macugen as Maintenance Treatment for Patients with Neovascular Age-Related Macular Degeneration
Palm Beach Gardens, FL - May 18, 2010 - Eyetech Inc. announced today that the British Journal of Ophthalmology (BJO) published online results from the LEVEL study evaluating MacugenTM (pegaptanib sodium) as a maintenance therapy in neovascular age-related macular degeneration (AMD). This large, open-label, uncontrolled, exploratory study enrolled 568 patients who had been treated one to three times for neovascular AMD, primarily with a non-selective VEGF-inhibitor such as ranibizumab or bevacizumab. During this induction phase, the mean visual acuity improved by 15.9 letters (49.6 letters to 65.5 letters). After entering the study, patients were switched to Macugen, a selective VEGF-inhibitor, with the possibility of using additional treatments if needed. At the end of this 54-week maintenance phase, mean final visual acuity was 61.8 letters. From the beginning of the induction phase to the end of maintenance phase, an approximately 16-month follow-up, 41 percent of patients gained at least 3 lines of visual acuity.
The study authors concluded that this induction-maintenance treatment strategy, using non-selective VEGF inhibitors then switching to Macugen, a selective VEGF inhibitor, may be an option for the long-term treatment of neovascular AMD. "A treatment protocol that combines the efficacy of a non-selective VEGF inhibitor with the safety profile of a selective VEGF inhibitor may be an attractive option, since elderly patients with AMD are already at increased risk of hypertension, stroke and other cardiovascular disease," said Thomas R. Friberg, M.D., lead investigator of the LEVEL study and Professor of Ophthalmology and Bio-Engineering at the University of Pittsburgh.
"This treatment approach may be of particular interest to retina specialists and their AMD patients with cardiovascular co-morbidities who require long-term treatment with anti-VEGF drugs to manage their neovascular AMD," continued Dr. Friberg. "Unlike non-selective VEGF inhibitors that should be administered monthly, Macugen is administered every six weeks. This substantially reduces the treatment burden on patients and their families."
Despite the limitations of an uncontrolled study, Macugen when used as a maintenance therapy showed adverse events rates similar to those observed in the pivotal Phase III V.I.S.I.O.N trial at one year. During one year of follow-up, there was no evidence of increased risk of endophthalmitis, retinal detachment of traumatic cataract. Most common ocular adverse events were punctate keratitis, eye pain and vitreous floaters. Reports of serious non-ocular, vascular events (including cardiovascular events) were rare.
About the LEVEL Study
LEVEL (EvaLuation of Efficacy and safety in maintaining Visual acuity with sEquential treatment of neovascuLar AMD) is a Phase IV, prospective, open-label, uncontrolled exploratory study designed to assess the efficacy of Macugen as a maintenance therapy in neovascular AMD patients who had at least one but not more than three prior treatments (induction phase) 30 to 120 days prior to study entry. Patients who showed significant clinical and/or anatomical improvement in their neovascular AMD, as determined by the study investigator, were enrolled in the LEVEL study and administered intravitreal injections of Macugen 0.3 mg every six weeks for 48 weeks with follow-up through week 54.
Additional treatments with other agents were allowed in the study eye at investigators' discretion for deteriorating AMD. Half of patients (283/568) required an additional treatment during the study, which was given approximately 5 months post-baseline on average. Of those who received an additional treatment, 46% required only one such treatment.
The results from the exploratory trial suggest that this induction/maintenance regimen may be a promising approach in the long-term treatment of ...
Ophthalmologist from the city of Hamden, CT, Dr. Jeffrey D. Gold speaks about ophthalmology practice and philosophy in this video interview. An ophthalmologist is doctor that deals with diseases of the eye. An ophthalmologist is a specialist in medical and surgical eye problems. Dr. Jeffrey D. Gold mentions that the roll an ophthalmologist is to treat eye diseases, and diagnose imperfections of the eye. However unlike optometrist an ophthalmologist is certified to perform surgery to correct imperfections of the eye. Dr. Jeffrey. D. Gold is also performs laser eye surgeries of all types. For more videos please visit the following site: *******www.youtube****/user/OphthalmologyHamden?feature=mhee
Dr. Jeffrey Gold, Ophthalmologist in Hamden CT, also serves the cities of: Hamden, North Haven, Bethany, Wallingford, Cheshire, New Haven, Woodbridge, Northford, and Prospect.
When you come into Medical Center Ophthalmology Associates, you'll finally get to see what you've been missing. In addition to vision exams and prescription glasses, we also treat most types of eye conditions and use FDA approved advanced laser technology. So contact our friendly and helpful office staff today to schedule your free consultation.
Get the facts on Laser-Assisted In Situ Keratomileusis (LASIK) & Cataract with this 100%-accurate animated video. Part of Focus Apps' Understanding Disease: Ophthalmology series, the LASIK & Cataract app demonstrates computer-controlled laser surgery. LASIK is used to correct myopia, astigmatism, and hyperopia. Understand cataracts, a condition where a clouded eye lens impairs vision. This happens when the protein balance in the lens is upset. Explore the anatomy of the eye, eye function, refractory errors, correction with LASIK, cataract classification, symptoms, diagnosis, complications, surgery, and recovery.
Get the facts on Glaucoma with this 100%-accurate animated video. Part of Focus Apps' Understanding Disease: Ophthalmology series, the Glaucoma app explores the optical system and the various factors that lead to this condition. Glaucoma is a group of eye diseases caused by a buildup of intra-ocular pressure. Also understand the diagnostic and treatment options available
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DETROIT, Jan. 11, 2007 / PRNewswire / â Design was a major focal point again this year at the 2007 North American International Auto Show (NAIAS). Several design-focused events were featured including EyesOn Design Awards, AutoWeek Design Forum, the Michelin Challenge Design and the "My Other Car Isâ¦" student project, as well as exclusive innovative exhibits and many exciting production and concept vehicles.
"Design continues to be an essential element driving our exhibitors who, once again are featuring elaborate displays showcasing jaw-dropping production and concept vehicles," said Robert Thibodeau, Jr., senior co-chairman for the NAIAS 2007. "Each and every year, we see the best in innovation and design that will drive our automotive industry in the future."
In its second year, the EyesOn Design Awards are quickly becoming a highly anticipated event at the NAIAS. Presented by the Detroit Institute of Ophthalmology, the EyesOn Design Awards feature the presentation of international design awards to honor and recognize the most significant automotive designs on display at NAIAS. The categories and award winner's included; Concept Implementation - Cadillac CTS; Aesthetics and Innovation - Chrysler Nassau; Spirit of Industrial Design - Jeep Trailhawk; and Functionality - Kia Kue .
In addition, the AutoWeek Design Forum, in its 14th year, examined and celebrated design as the ultimate differentiating factor. Featured speakers included Robert Boniface, director of design, Advanced Design, General Motors; Moray Callum, design director, North America Car, Ford Motor Company; and Ralph V. Gilles, vice president - JeepÂ®/Truck and Component Design, Chrysler Group.
"It's exciting to have so many unique design events associated with the NAIAS," said Carl Galeana, co-chairman for the NAIAS 2007. "A lot of creativity and hard work goes into designing the vehicles on display, so the NAIAS is proud to have the opportunity to help honor the work of these designers."
The Michelin Challenge Design was created to celebrate, promote, publicize and give visibility to creative thinking and innovation in vehicle design. Candidates of this annual international design competition were presented with the challenge of illustrating outstanding automotive design and safe interaction for a variety of roadway users.
Lastly, transportation design students from Detroit's College for Creative Studies (CCS) and engineering students from the University of Michigan (U-M) were put to task with the "My other car isâ¦" assignment during the 18th annual American Iron and Steel Institute (AISI) summer design internship. Students from CCS and U-M produced exhilarating concept vehicles that targeted Generation X, Baby Boomers and the Millennial generation. The models of these "other car" concepts are displayed at NAIAS 2007.
A new public survey released by the American Academy of Ophthalmology finds that few Americans believe they are at risk for eye disease. Yet more than half of all Americans will have some form of eye disease as they get older.
With diabetes rates continuing to rise in America, the American Academy of Ophthalmology is calling for screenings for diabetic retinopathy during Novemberâs Diabetic Eye Disease Awareness month.
At New Yorks Affordable LASIK we provide complete high quality eye lasik care to our patients.
Emil William Chynn, MD is one of New York City's most experienced and best-trained LASIK surgeons. A diplomate of the American Board of Ophthalmology (ABO), he is a board-certified ophthalmologist.
Nancy Stewart never had vision problems until last year when her eyesight became cloudy. her diagnosis - cataracts. however, her ophthalmologist also found a much more serious problem, damaged blood vessels due to diabetes known as diabetic retinopathy. According to experts many eye diseases don't have any symptoms. but few americans see themselves at risk according to a recent survey by the american academy of ophthalmology. To educate the public and help prevent eye disease, the american academy of ophthalmology is now recommending eye screening starting at age 40. The academy hopes that the new recommendations along with education will help older americans catch eye disease early when it is treatable.
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What do a bungee cord, a pan of frying bacon and lawn-care chemicals have in common? They are just a few of the common items around the house that can cause eye injuries, which a new study from the American Academy of Ophthalmology (Academy) and the American Society of Ocular Trauma (ASOT) reports are increasingly occurring at home. The new Eye Injury Snapshot, a clinical survey of eye injuries across the U.S., found that nearly half of the 2.5 million eye injuries that Americans suffer annually now happen in and around the home in common places like the lawn, garden, kitchen or garage. For more information on this story and others, visit www.NewsInfusion****
At Eye Doctors of Washington DC, our board certified cataract surgeons have performed thousands of cataract surgery cases over the years. Our surgeons are internationally renowned for the excellence in ophthalmology andcommitment to their patients.
Steven Rosenberg MD ..
Pediatric Ophthalmology ..
Medical School: Columbia University ..
Residency: Manhattan Eye and Ear ..
Fellowship: Scottish Rite Children's Medical Center