Author Interviews, Ophthalmology / 30.07.2020 Interview with: CARL D. REGILLO, MD, FACS Carl D. Regillo, MD, FACS Chief, Retina Service Wills Eye Hospital What is the background for the Phase III Archway study? Would you briefly explain what Neovascular Age-Related Macular Degeneration means?  Genentech announced in late July the results from the Phase III Archway study evaluating Port Delivery System (PDS) with ranibizumab (PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD) which showed PDS enabled 98.4% of people to go six months between treatments, while achieving vision outcomes equivalent to those receiving monthly ranibizumab eye injections, a current standard of care. AMD is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading and is a leading cause of blindness for people age 60 and over in the U.S. Neovascular AMD is an advanced form of AMD that can cause rapid and severe vision loss. Approximately 11 million people in the United States have some form of AMD and of those, about 1.1 million have nAMD.  (more…)
Author Interviews, BMJ, Environmental Risks, Ophthalmology / 21.08.2019 Interview with: Professor Suh-Hang Hank Ju, PhD Kaohsiung Medical University Taiwan What is the background for this study? Response: Nitrogen dioxide (NO2) and carbon monoxide (CO) are 2 major traffic pollutants, which have been shown to increase a risk for respiratory and cardiovascular diseases. We previously showed that chronic exposure of NO2 is also associated with dementia. age-related macula degeneration (AMD) is a leading cause of blindness. Given the increase of traffic pollutants in many urbanized cities, we investigated whether these two traffic pollutants are associated with the development of age-related macula degeneration in Taiwan. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology / 13.01.2019 Interview with: Eugene Yu-Chuan Kang, MD. House Staff, Department of Ophthalmology Chang Gung Memorial Hospital Chang Gung University, School of Medicine What is the background for this study?   Response: More and more patients suffered from diabetes mellitus (DM) around the world, as well diabetic complications such as diabetic retinopathy (DR). DR is one of the major causes of blindness in working-age adults. In addition to the cost of treatment for patients with advanced DR, loss of visual function also yields a great burden to the family and society. For advanced DR, surgical interventions such as retinal laser, intravitreal injection, and vitrectomy are needed. However, those surgical interventions for severe DR can only retard or stop disease progression. If DR can be prevented or slowed by medical treatments, the burden of medical costs for treating severe DR may be decreased. Statin, an HMG-CoA reductase inhibitor, was discussed frequently in the recent years. Multiple functions of statins besides their lipid lowering effect were discovered. Previous investigations have reported that statin therapy could reduce mortality rate and decrease risk of cardiovascular diseases. In our study, we wanted to figure out if statin therapy may have any association between diabetic retinopathy.  (more…)
Author Interviews, Compliance, JAMA, Macular Degeneration, Ophthalmology / 25.08.2018 Interview with: Jason Hsu, MD Retina Service, Wills Eye Hospital Associate Professor of Ophthalmology Thomas Jefferson University Mid Atlantic Retina Anthony Obeid MD MPH School of Public Health The University of Sydney · What is the background for this study? What are the main findings?  Response: Neovascular age-related macular degeneration (nAMD) is a vision-threatening disease that often afflicts elderly patients. The introduction of intravitreal anti-vascular endothelial growth factor treatment drastically improved the prognosis of eyes with nAMD. Despite its efficacy, patients require consistent follow-up (sometimes as often as monthly), with ongoing injections to maintain the visual benefits of the drug. Unfortunately, few studies have reported the number of patients that do not follow-up with recommended guidelines. Moreover, there remains limited evidence on the risk factors associated with loss to follow-up. Our study, consisting of 9007 patients with a history of nAMD receiving treatment between 2012 and 2016, evaluated both these parameters. We defined loss to follow-up as having at least one injection without a subsequent follow-up visit within 12 months post-treatment. Using this definition, we found that over 20% of patients are lost to follow-up over the entire study period. We further identified key risk factors associated with loss to follow-up, which included patients of older age, race, patients residing in a region of a lower average adjusted gross income, patients living at greater distances from clinic, patients with active nAMD in only one eye, and patients with worse visual acuity. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, Technology / 13.12.2017 Interview with: Dr. Tien Yin Wong MD PhD Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Medical School, National University of Singapore Singapore What is the background for this study? What are the main findings? Response: Currently, annual screening for diabetic retinopathy (DR) is a universally accepted practice and recommended by American Diabetes Association and the International Council of Ophthalmology (ICO) to prevent vision loss. However, implementation of diabetic retinopathy screening programs across the world require human assessors (ophthalmologists, optometrists or professional technicians trained to read retinal photographs). Such screening programs are thus challenged by issues related to a need for significant human resources and long-term financial sustainability. To address these challenges, we developed an AI-based software using a deep learning, a new machine learning technology. This deep learning system (DLS) utilizes representation-learning methods to process large data and extract meaningful patterns. In our study, we developed and validated this using about 500,000 retinal images in a “real world screening program” and 10 external datasets from global populations. The results suggest excellent accuracy of the deep learning system with sensitivity of 90.5% and specificity of 91.6%, for detecting referable levels of DR and 100% sensitivity and 91.1% specificity for vision-threatening levels of DR (which require urgent referral and should not be missed). In addition, the performance of the deep learning system was also high for detecting referable glaucoma suspects and referable age-related macular degeneration (which also require referral if detected). The deep learning system was tested in 10 external datasets comprising different ethnic groups: Caucasian whites, African-Americans, Hispanics, Chinese, Indians and Malaysians (more…)
Author Interviews, Lancet, Macular Degeneration, Ophthalmology / 18.05.2017 Interview with: Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD What is the background for this study? What are the main findings? Response: Patients with wet age-related macular degeneration (AMD) have increased levels of vascular endothelial growth factor (VEGF) in their eyes resulting in growth of abnormal blood vessels that leak fluid into the retina and reduce vision. The current treatment is to inject proteins that block VEGF which initially provides a very good effect, but repeated injections are needed. Patients sometimes are unable to keep up the frequency of visits and injections needed to keep the disease quiet and over time there is often gradual loss of vision. The aim of this study was to test a new approach through which a viral vector is injected into the eye resulting in production of a protein that block VEGF in the eye reducing the need for repeated injections. These are the major findings: 1) Intravitreous injection of an AAV2 vector expressing a protein that blocks vascular endothelial growth factor (VEGF) was safe and well-tolerated. (2) 5 of 10 patients injected with the highest dose (2 × 10¹⁰ vector genomes) had measurable levels of the therapeutic protein in samples removed from the front of the eye- all of these patients had no or very low levels of anti-AAV2 serum antibodies and 4 of the 5 patients who did not show expression had high anti-AAV2 serum antibodies (3) Eleven patients had fluid in or under the retina before vector injection and 6 of them showed substantial reduction of the fluid which is the desired outcome. (more…)
Author Interviews, Macular Degeneration, Ophthalmology, Technology / 17.05.2017 Interview with: Dr Felicity de Cogan PhD Institute of Inflammation and Ageing University of Birmingham What is the background for this study? Response: The University of Birmingham has a unique approach to developing technologies. By locating chemists, engineers, biologists and clinicians in the same department it revolutionised the way research problems are solved. Initially, Felicity de Cogan was researching cell penetrating peptides (CPP) and their uses in microbiology. However, after joining forces with Neuroscientists, Dr Lisa Hill and Professor Ann Logan at the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre (NIHR SRMRC) together with the clinicians and Vision Scientists, Dr Mei Chen and Professor Heping Xu at the Queen’s University Belfast it became evident that there was huge potential to deliver drugs in the eye. This was the start of the project and it developed rapidly from there. (more…)
Author Interviews, Cost of Health Care, JAMA, Macular Degeneration, Ophthalmology, Telemedicine / 02.04.2017 Interview with: John Wittenborn Senior research scientist NORC's Public Health Analytics University of Chicago What is the background for this study? What are the main findings? Response:The emergence of anti-VEGF treatment for wet-form AMD (choroidal neovascularization) has had a dramatic impact on preserving vision for many Americans. However, community-based studies show that most patients are not diagnosed with wet-form AMD until they have already lost a significant, and largely unrecoverable amount of their vision.  Early detection of wet-form AMD is key to effective treatment and the preservation of vision. The ForeseeHome telemonitoring technology provides patients with a means to check their own eyes on a daily basis to detect the earliest signs of vision loss from wet-form AMD. This is a novel technology that has the potential to improve visual health outcomes for AMD patients.  A prior clinical trial (the AREDS-2 HOME study) demonstrated that this technology can detect wet-form AMD earlier, and with less vision loss than standard care alone. However, that is exactly where that study ended as it reported no cost information nor follow-up. Since the end of this study, the device has been cleared by the FDA and approved for reimbursement by Medicare for certain higher risk patients, but no study has yet considered the long-term implications of adoption of this technology. In our analysis, we use a computer simulation model to essentially estimate what will come next, after patients realize earlier detection of wet-form AMD by utilizing home monitoring. Basically, we follow simulated patients from the time they begin monitoring for the rest of their lives, recording the likely impacts of home monitoring on patients’ long term outcomes including visual status, costs and quality of life. We find that home telemonitoring among the population indicated for reimbursement by Medicare would cost $35,663 per quality adjusted life year (QALY) gained.  Medicare would expect to incur $1,312 in net budgetary costs over 10 years for each patient who initiates monitoring.  However, Medicare patients may expect to achieve lifetime net savings when accounting for the chance of avoided vision loss and its associated costs later in life. (more…)
Aging, Author Interviews, Genetic Research, JAMA, Macular Degeneration, Ophthalmology / 08.12.2016 Interview with: dr-anneke-i-den-hollanderAnneke I. den Hollander, PhD Department of Ophthalmology and Department of Human Genetics Donders Institute for Brain, Cognition, and Behaviour Radboud University Medical Center Nijmegen, the Netherland What is the background for this study? What are the main findings? Response: Age-related macular degeneration is caused by a combination of genetic and environmental factors. Rare genetic variants in the complement system have been described in AMD, but their effect remains largely unexplored. In this study we aimed to determine the effect of rare genetic variants in the complement system on complement levels and activity in serum. What are the main findings? Response: Carriers of CFI variants showed decreased FI levels, carriers of C9 Pro167Ser had increased C9 levels, while C3 and FH levels were not altered. Carriers of CFH and CFI variants had a reduced ability to degrade C3b, which for CFI was linked to reduced serum FI levels. (more…)
Author Interviews, Macular Degeneration, Radiology, Stanford / 10.11.2014

Daniel L. Rubin, MD, MS  Assistant Professor of Radiology and Medicine (Biomedical Informatics) Department of Radiology | Stanford University Stanford, CA Interview with: Daniel L. Rubin, MD, MS  Assistant Professor of Radiology and Medicine (Biomedical Informatics) Department of Radiology | Stanford University Stanford, CA 94305-5488 Medical Research: What is the background for this study? What are the main findings? Dr. Rubin: Age-Related Macular Degeneration is the leading cause of blindness and central vision loss among adults older than 65. An estimated 10-15 million people in the United States suffer from the disease, in which the macula — the area of the retina responsible for vision — shows signs of degeneration. While about one of every five people with AMD develop the so-called “wet” form of the disease that can cause devastating blindness. In wet AMD, abnormal blood vessels accumulate underneath the macula and leak blood and fluid. When that happens, irreversible damage to the macula can quickly ensue if not treated quickly. Until now, there has been no effective way to tell which individuals with AMD are likely to convert to the wet stage. Current treatments are costly and invasive — they typically involve injections of medicines directly into the eyeball — making the notion of treating people with early or intermediate stages of Age-Related Macular Degeneration a non-starter. In our study, we report on a computerized method that analyzes images of the retina obtained with a test called spectral domain optical coherence tomography (SD-OCT), and our method can predict, with high accuracy, whether a patient with mild or intermediate Age-Related Macular Degeneration will progress to the wet stage. Our method generates a risk score, a value that predicts a patient’s likelihood of progressing to the wet stage within one year, three years or five years. The likelihood of progression within one year is most relevant, because it can be used to guide a recommendation as to how soon to schedule the patient’s next office visit. In our study, we analyzed data from 2,146 scans of 330 eyes in 244 patients seen at Stanford Health Care over a five-year period. Patients were followed for as long as four years, and predictions of the model were compared with actual instances of conversion to wet AMD. The model accurately predicted every occurrence of conversion to the wet stage of AMD within a year. In approximately 40% of the cases when the model predicted conversion to wet AMD within a year, the prediction was not borne out, however. We are currently refining the model to reduce the frequency of these false positives. (more…)
Author Interviews, General Medicine, Macular Degeneration, Stroke / 31.10.2014 Interview with: Takashi Ueta, M.D., Ph.D. Assistant Professor, Department of Ophthalmology Graduate School and Faculty of Medicine The University of Tokyo Medical Research: What is the background for this study? What are the main findings? Dr. Ueta: In 2009 we had reported an initial systematic review and meta-analysis which include pivotal RCTs but the number of the included studies were only 3 (MARINA, ANCHOR, FOCUS). During the following several years, more trials comparing different dosages and frequencies of ranibizumab treatment were conducted, which made us to update our meta-analysis. Based on our updated meta-analysis, increase in several systemic vascular adverse events was observed: 86% increase in odds ratio (OR) for the risk of cerebrovascular accident (CVA) when 0,5 mg ranibizumab used. 89% increase in OR for the risk of CVA when monthly ranibizumab of any dosage is used. 57% increase in OR for the risk of non-ocular hemorrhage when ranibizumab of any dosage with any frequency is used. (more…)
JAMA, Ophthalmology / 20.09.2014

Szilárd Kiss, MD Director of Clinical Research Director of Compliance  Associate Professor of Ophthalmology Weill Cornell Medical College NewYork-Presbyterian Hospital New York, New York Interview with: Szilárd Kiss, MD Director of Clinical Research Director of Compliance  Associate Professor of Ophthalmology Weill Cornell Medical College NewYork-Presbyterian Hospital New York, New York 10021 Medical Research: What is the background for your study? Dr. Kiss: There has been a good deal of publicity about bevacizumab (Avastin; a Genetech/Roche antibody originally developed for treatment of cancer but now used widely to treat macular degeneration and diabetic retinopathy) being prepared by (mostly unregulated) compounding pharmacies for injection into the eye, and being associated with pathogen contamination. (more…)
Author Interviews, General Medicine, Macular Degeneration, Ophthalmology / 19.03.2014

Chung-Jung Chiu DDS PhD Scientist II, JM USDA Human Nutrition Research Center on Aging Assistant Professor, School of Medicine Tufts University Boston MA Interview with: Chung-Jung Chiu DDS PhD Scientist II, JM USDA Human Nutrition Research Center on Aging Assistant Professor, School of Medicine Tufts University Boston MA 02111 What are the main findings of the study? Answer: In this study, we found that advanced age-related macular degeneration (AMD) is predictable by using clinically readily available information. We devised a simple algorithm to summarize the clinical predictors and showed the validity of our prediction model in both clinic-based and community-based cohorts. We also develop an application (App) for the iPhone and iPad as a practical tool for our prediction model. (more…)
Antioxidants, Author Interviews, Macular Degeneration, Ophthalmology / 20.01.2014

Jie Jin Wang MMed (Clin Epi) MAppStat PhD Professor Australian NHMRC Senior Research Fellow (Level B) Centre for Vision Research Westmead Millennium Institute University of Sydney C24 Westmead Hospital, NSW 2145 Interview with: Jie Jin Wang MMed (Clin Epi) MAppStat PhD Professor Australian NHMRC Senior Research Fellow (Level B) Centre for Vision Research Westmead Millennium Institute University of Sydney C24 Westmead Hospital, NSW 2145 Australia What are the main findings of the study? Answer: We documented a consistent association between high dietary intake of lutein/zeaxanthin (LZ) and a reduced long-term risk of early age-related macular degeneration (AMD) in persons who carry ≥2 risk alleles of either or both the complement factor H (CFH-rs1061170) and/or the age-related maculopathy susceptibility gene 2 (ARMS2-rs10490924) in two older population-based cohorts. (more…)