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Advancing Therapeutic Development for Dry Age-Related Macular Degeneration (AMD) Workshop in Brief (2015) / Chapter Skim
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Advancing Therapeutic Development forDry Age-Related Macular Degeneration (AMD)-Workshop in Brief
Pages 1-8

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From page 1...
... noted that AMD is one of the leading causes of suffering as individuals grow older, yet there are currently no treatments available for the most common form of AMD, dry AMD. Advancements in drug discovery and development have been limited and slow due to issues surrounding disease characterization, surrogate endpoints, and clinical trial design, according to Cynthia Grosskreutz, Global Translational Medicine Head for Ophthalmology at Novartis Institutes for Biomedical Research, Inc.
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From page 2...
... approximately 6.5 years, during which time the patient experiences gradual visual loss, dark adaptation abnormalities, difficulty reading, and problems with face recognition, she added. Alternatively, the neovascular form of AMD may develop, probably in response to pro-angiogenic factors, said Chew.
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From page 3...
... Enriching the study population for individuals at high risk of rapid progression, or accepting less statistical power, e.g., through higher tolerance of type I or type II errors, might enable more rapid determination of whether to move forward, noted Grosskreutz. According to a few workshop participants, testing multiple dosing regimens in a Phase IIa trial as well as in the confirmatory Phase III trial might also expedite drug development.
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From page 4...
... In addition, she noted the need to better define anatomic descriptors of retinal changes in eyes with GA that are reproducible across larger populations. With a long tradition of research, the availability of standardized protocols, and demonstrated correlation with success in daily activities, David Birch, Chief Scientific and Executive Officer of the Retina Foundation of the Southwest, noted that the gold standard functional measure for assessing AMD progression has been best corrected visual acuity (BCVA)
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From page 5...
... In particular, Potter cited the need to intervene early in a slowly progressing disease, the lack of validated measures to detect early disease and clarity with regard to pathophysiology, the apparent need to attack multiple targets, and the lack of effective treatments. As a result of these and other challenges, many Phase III failures have cast a pall over AD drug development, prompting the search for new strategies that might de-risk the process, he stated.
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From page 6...
... These issues further support the need for collaboration across multiple stakeholder groups, noted David Michelson, Vice President of Clinical Neuroscience and Ophthalmology at Merck Research Laboratories. Workshops such as this one represent an opportunity to bring key stakeholders together to develop a unified approach on how best to study and develop effective treatments for dry AMD.
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From page 7...
... 2009. Patient reported outcome measures: use in medical product development to support labelling claims.
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From page 8...
... National Institute on Alcohol Abuse the National Eye Institute, National Institute of Mental Health, National and Alcoholism Institute of Neurological Disorders and Stroke, National Institute on Katja Brose Cell Press Walter Koroshetz Aging, National Institute on Alcohol Abuse and Alcoholism, National National Institute of Neurological Institute on Drug Abuse, NIH Blueprint for Neuroscience Research, Daniel Burch Disorders and Stroke Pharmaceutical Product Development, and National Center for Complementary and Alternative Medicine; Inc. Alan Leshner Department of Veterans Affairs; Eli Lilly and Company; Fast Forward, American Association for the LLC; Foundation for the National Institutes of Health; the Gatsby Sarah Caddick Advancement of Science Gatsby Charitable Foundation Charitable Foundation; GlaxoSmithKline, Inc.; Johnson & Johnson Husseini Manji Pharmaceutical Research and Development, LLC; Lundbeck Research Rosa Canet-Aviles Johnson & Johnson Pharmaceuticals National Institutes of Health USA; Merck Research Laboratories; The Michael J
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Key Terms

  • drug development
  • dry amd
  • eye institute
  • visual acuity
  • functional ability

  • national eye
  • clinical trial
  • clinical classification
  • functional endpoints
  • visual function

  • merck research
  • multiple targets
  • alternative medicine
  • phase iii
  • low luminance

  • share data
  • macular degeneration
  • alcohol abuse
  • effective treatments
  • national multiple

  • efficient clinical
  • drug abuse
  • assessing amd
  • macular research
  • amd progression

  • amd typically
  • amd patients
  • visual impairment
  • visual loss
  • multiple sclerosis


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