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104. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials

Author

Heier, Jeffrey S, primary, Khanani, Arshad M, additional, Quezada Ruiz, Carlos, additional, Basu, Karen, additional, Ferrone, Philip J, additional, Brittain, Christopher, additional, Figueroa, Marta S, additional, Lin, Hugh, additional, Holz, Frank G, additional, Patel, Vaibhavi, additional, Lai, Timothy Y Y, additional, Silverman, David, additional, Regillo, Carl, additional, Swaminathan, Balakumar, additional, Viola, Francesco, additional, Cheung, Chui Ming Gemmy, additional, Wong, Tien Y, additional, Abbey, Ashkan, additional, Abdulaeva, Elmira, additional, Abraham, Prema, additional, Adan Civera, Alfredo, additional, Agostini, Hansjurgen, additional, Alezzandrini, Arturo, additional, Alfaro, Virgil, additional, Almony, Arghavan, additional, Altay, Lebriz, additional, Amini, Payam, additional, Antoszyk, Andrew, additional, Aradi, Etelka, additional, Arias, Luis, additional, Arnold, Jennifer, additional, Asaria, Riaz, additional, Astakhov, Sergei, additional, Astakhov, Yury, additional, Awh, Carl C., additional, Balaratnasingam, Chandra, additional, Banerjee, Sanjiv, additional, Baumal, Caroline, additional, Becker, Matthias, additional, Belfort, Rubens, additional, Bratko, Galina, additional, Bridges, William Jr. Z, additional, Brown, Jamin, additional, Brown, David M., additional, Budzinskaya, Maria, additional, Buffet, Sylvia, additional, Burgess, Stuart, additional, Byon, Iksoo, additional, Cagini, Carlo, additional, Calzada, Jorge, additional, Cameron, Stone, additional, Campochiaro, Peter, additional, Carlson, John, additional, Carneiro, Angela, additional, Chan, Clement, additional, Chang, Emmanuel, additional, Chang, Andrew, additional, Chao, Daniel, additional, Chaudhry, Nauman, additional, Chee, Caroline, additional, Cheek, Andrew, additional, Chen, Shih-Jen, additional, Chen, San-Ni, additional, Cheung, Gemmy, additional, Chexal, Saradha, additional, Chittum, Mark, additional, Chow, David, additional, Cole, Abosede, additional, Connolly, Brian, additional, Cornut, Pierre Loic, additional, Couvillion, Stephen, additional, Danzig, Carl, additional, Daskalov, Vesselin, additional, Dessouki, Amr, additional, Devin, Francois, additional, Dollin, Michael, additional, Dolz, Rosa, additional, Downey, Louise, additional, Dreyer, Richard, additional, Dugel, Pravin, additional, Eichenbaum, David, additional, Eldem, Bora, additional, Engstrom, Robert, additional, Escobar, Joan Josep, additional, Eter, Nicole, additional, Faber, David W., additional, Falk, Naomi, additional, Feiner, Leonard, additional, Fernandez Vega, Alvaro, additional, Ferrone, Philip, additional, Figueroa, Marta, additional, Fine, Howard, additional, Fineman, Mitchell, additional, Fox, Gregory M., additional, Francais, Catherine, additional, Franco, Pablo, additional, Fraser-Bell, Samantha, additional, Fung, Nicholas, additional, Furno Sola, Federico, additional, Gale, Richard, additional, Garcia-Layana, Alfredo, additional, Gasperini, Julie, additional, Gawecki, Maciej, additional, Ghanchi, Faruque, additional, Gill, Manjot, additional, Giunta, Michel, additional, Glaser, David, additional, Goldstein, Michaella, additional, Gomez Ulla, Francisco, additional, Gomi, Fumi, additional, Gonzalez, Victor, additional, Graff, Jordan, additional, Gupta, Sunil, additional, Guthoff, Rainer, additional, Guymer, Robyn, additional, Haas, Anton, additional, Hampton, Robert, additional, Hatz, Katja, additional, Hayashi, Ken, additional, Heier, Jeffrey, additional, Herba, Ewa, additional, Hershberger, Vrinda, additional, Higgins, Patrick, additional, Holekamp, Nancy, additional, Honda, Shigeru, additional, Howard, James, additional, Hu, Allen, additional, Huddleston, Stephen, additional, Iida, Tomohiro, additional, Imaizumi, Hiroko, additional, Ito, Yasuo, additional, Ito, Yasuki, additional, Itty, Sujit, additional, Javey, Golnaz, additional, Javid, Cameron, additional, Kaga, Tatsushi, additional, Kaluzny, Jakub, additional, Kang, Se Woong, additional, Kapoor, Kapil, additional, Karabas, Levent, additional, Kawasaki, Tsutomu, additional, Kelty, Patrick, additional, Kerenyi, Agnes, additional, Khanani, Arshad, additional, Khoramnia, Ramin, additional, Khurana, Rahul, additional, Kimura, Kazuhiro, additional, Klein-Mascia, Kendra, additional, Kobayashi, Namie, additional, Kodjikian, Laurent, additional, Koizumi, Hideki, additional, Kokame, Gregg, additional, Kulikov, Alexey, additional, Kwong, Henry, additional, Kwun, Robert, additional, Lai, Timothy, additional, Lai, Chi-Chun, additional, Lalonde, Laurent, additional, Lanzetta, Paolo, additional, Larsen, Michael, additional, Lavina, Adrian, additional, Lee, Won Ki, additional, Lee, ji Eun, additional, Lee, Seong, additional, Levy, Jaime, additional, Lindsell, Lucas, additional, Liu, Mimi, additional, London, Nikolas, additional, Lotery, Andrew, additional, Lozano Rechy, David, additional, Luckie, Alan, additional, Maberley, David, additional, Maeno, Takatoshi, additional, Mahmood, Sajjad, additional, Makkouk, Fuad, additional, Marcus, Dennis, additional, Margherio, Alan, additional, Masse, Helene, additional, Matsubara, Hisashi, additional, Maturi, Raj, additional, Mehta, Sonia, additional, Menon, Geeta, additional, Mentes, Jale, additional, Michels, Mark, additional, Mitamura, Yoshinori, additional, Mitchell, Paul, additional, Mohamed, Quresh, additional, Mones, Jordi, additional, Montemayor Lobo, Rodrigo, additional, Montero, Javier, additional, Moore, Jeffrey, additional, Mori, Ryusaburo, additional, Morori-Katz, Haia, additional, Mukherjee, Raj, additional, Murata, Toshinori, additional, Muzyka-Wozniak, Maria, additional, Nardi, Marco, additional, Narendran, Niro, additional, Nicolo, Massimo, additional, Nielsen, Jared, additional, Nishimura, Tetsuya, additional, Noda, Kousuke, additional, Nowinska, Anna, additional, Oh, Hideyasu, additional, Ohr, Matthew, additional, Okada, Annabelle, additional, Oleksy, Piotr, additional, Ono, Shinji, additional, Ozdek, Sengul, additional, Ozturk, Banu, additional, Pablo, Luis, additional, Park, Kyu Hyung, additional, Parke, D. Wilki, additional, Parravano, Maria Cristina, additional, Patel, Praveen, additional, Patel, Apurva, additional, Patel, Sunil, additional, Patel, Sugat, additional, Pauleikhoff, Daniel, additional, Pearce, Ian, additional, Pearlman, Joel, additional, Petkova, Iva, additional, Pieramici, Dante, additional, Pozdeyeva, Nadezhda, additional, Qureshi, Jawad, additional, Raczynska, Dorota, additional, Ramirez Estudillo, Juan, additional, Rathod, Rajiv, additional, Razavi, Hessam, additional, Reilly, Gayatri, additional, Ricci, Federico, additional, Rich, Ryan, additional, Romanowska-Dixon, Bożena, additional, Rosenblatt, Irit, additional, Ruiz Moreno, Jose Maria, additional, Sacu, Stefan, additional, Saedon, Habiba, additional, Saeed, Usman, additional, Sagong, Min, additional, Sakamoto, Taiji, additional, Sandhu, Sukhpal, additional, Sararols, Laura, additional, Saravia, Mario, additional, Schadlu, Ramin, additional, Schlottmann, Patricio, additional, Sekiryu, Tetsuju, additional, Seres, András, additional, Sermet, Figen, additional, Shah, Sumit, additional, Shah, Rohan, additional, Shah, Ankur, additional, Sheidow, Thomas, additional, Sheth, Veeral, additional, Shiragami, Chieko, additional, Sikorski, Bartosz, additional, Silva, Rufino, additional, Singerman, Lawrence, additional, Sisk, Robert, additional, Sørensen, Torben L., additional, Souied, Eric, additional, Spinak, David-J, additional, Staurenghi, Giovanni, additional, Steinmetz, Robert, additional, Stoller, Glenn, additional, Stoltz, Robert, additional, Suan, Eric, additional, Suner, Ivan, additional, Suzanne, Yzer, additional, Tadayoni, Ramin, additional, Takahashi, Kanji, additional, Takayama, Kei, additional, Taleb, Alexandre, additional, Talks, James, additional, Terasaki, Hiroko, additional, Thompson, John, additional, Toth-Molnar, Edit, additional, Tran, Khoi, additional, Tuli, Raman, additional, Uchiyama, Eduardo, additional, Vajas, Attila, additional, Van Lith-Verhoeven, Janneke, additional, Varsanyi, Balazs, additional, Virgili, Gianni, additional, Vogt, Gábor, additional, Völker, Michael, additional, Warrow, David, additional, Weber, Pamela, additional, Wells, John A., additional, Wickremasinghe, Sanjeewa, additional, Wieland, Mark, additional, Williams, Geoff, additional, Williams, Thomas, additional, Wong, David, additional, Wong, King, additional, Wong, James, additional, Wong, Ian, additional, Wong, Robert, additional, Wowra, Bogumil, additional, Wykoff, Charles C., additional, Yamashita, Ayana, additional, Yasuda, Kanako, additional, Yilmaz, Gursel, additional, Yiu, Glenn, additional, Yoneda, Ai, additional, Yoon, Young Hee, additional, Yoreh, Barak, additional, Yu, HyeongGon, additional, Yu, Seung Young, additional, Yurieva, Tatiana, additional, Zambrano, Alberto, additional, Zatorska, Barbara, additional, and Zeolite, Carlos, additional

Published
2022
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105. Clinical Characteristics and Outcomes of Eyes with Intraocular Inflammation after Brolucizumab: Post Hoc Analysis of HAWK and HARRIER

Author

Singer, Michael, primary, Albini, Thomas A., additional, Seres, András, additional, Baumal, Caroline R., additional, Parikh, Soumil, additional, Gale, Richard, additional, Kaiser, Peter K., additional, Lobach, Iryna, additional, Feltgen, Nicolas, additional, Joshi, Mayur R., additional, Ziemssen, Focke, additional, and Bodaghi, Bahram, additional

Published
2022
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109. Diagnostic Accuracy of Monitoring Tests of Fellow Eyes in Patients with Unilateral Neovascular Age-Related Macular Degeneration: Early Detection of Neovascular Age-Related Macular Degeneration Study

Author

Sivaprasad, Sobha, Banister, Katie, Azuara-Blanco, Augusto, Goulao, Beatriz, Cook, Jonathan A, Hogg, Ruth, Scotland, Graham, Heimann, Heinrich, Lotery, Andrew, Ghanchi, Faruque, Gale, Richard, Menon, Geeta, Downey, Louise, Hopkins, Nicola, Scanlon, Peter, Burton, Ben, Ramsay, Craig, and Chakravarthy, Usha

Subjects
genetic structures, Amsler, OCT, visual acuity, sensitivity and specificity, Fluorescein angiography,diagnostic accuracy, sense organs, neovascular age related macular degeneration, eye diseases
Abstract

OBJECTIVE: To evaluate the diagnostic accuracy of routinely used tests of visual function and retinal morphology compared to fundus fluorescein angiography (FFA) to detect onset of active macular neovascularisation in unaffected fellow eyes of patients with unilateral neovascular age-related macular degeneration (nAMD).DESIGN: Prospective diagnostic accuracy cohort study conducted in 24 eye clinics in the UK over 3 years.PARTICIPANTS: Older adults (>50y) with recently diagnosed unilateral nAMD with a fellow (study) eye free of nAMD.INDEX TESTS: Self-reported vision, Amsler, clinic measured visual acuity, fundus assessment, and spectral domain optical coherence tomography (OCT).REFERENCE STANDARD: FFA.MAIN OUTCOME MEASURE: Sensitivity and specificity of the 5 index tests.RESULTS: Of 552 participants monitored for up to three years, 145 (26.3%) developed active nAMD in the study eye, of whom 120 had an FFA at detection and constituted the primary analysis cohort. Index test positives at nAMD detection in those confirmed by FFA were, self reported vision much worse 5, distortion on Amsler 33, 10-letter decrease in acuity from baseline 36, fundus examination 64; OCT 110. Index test sensitivities % (95% CI) were: self-reported vision 4.2 (1.6 to 9.8); Amsler 33.7 ( 25.1 to 43.5); visual acuity 30.0 ( 22.5 to 38.7); fundus examination 53.8 (44.8 to 62.5) and OCT 91.7 (85.2 to 95.6). All 5 index test specificities were high at 97.0 (94.6 to 98.5), 81.4 [76.4 to 85.5), 66.3 (61.0 to 71.1), 97.6 (95.3, 98.9), and 87.8 (83.8, 90.9), respectively. The combination of OCT with one other index test which was a secondary outcome measure increased sensitivity marginally and decreased specificity for all combinations except fundus examination.CONCLUSION: Tests of self-reported change in vision, unmasking of new distortion, measurements of acuity and fundus checks to diagnose active nAMD performed poorly in contrast to OCT. Our findings support a change to guidelines in clinical practice to monitor for onset of nAMD.

Published
2021

111. Monsanto's sealed documents reveal the truth behind roundup's toxicological dangers

Author

Gale, Richard and Null, Gary

Subjects
Monsanto Co. -- Records and correspondence, Herbicides -- Safety and security measures, Agricultural chemicals industry -- Records and correspondence, Health
Abstract

The year 2015 wasn't kind to Monsanto. That March, the World Health Organization declared that the company's flagship product, its herbicide glyphosate or Roundup, is a probable human carcinogen. Increasingly, [...]

Published
2016

112. Diagnostic Accuracy of Monitoring Tests of Fellow Eyes in Patients with Unilateral Neovascular Age-Related Macular Degeneration

Author

Sivaprasad, Sobha, primary, Banister, Katie, additional, Azuro-Blanco, Augusto, additional, Goulao, Beatriz, additional, Cook, Jonathan A., additional, Hogg, Ruth, additional, Scotland, Graham, additional, Heimann, Heinrich, additional, Lotery, Andrew, additional, Ghanchi, Faruque, additional, Gale, Richard, additional, Menon, Geeta, additional, Downey, Louise, additional, Hopkins, Nicola, additional, Scanlon, Peter, additional, Burton, Ben, additional, Ramsay, Craig, additional, and Chakravarthy, Usha, additional

Published
2021
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113. Early detection of neovascular age-related macular degeneration: an economic evaluation based on data from the EDNA study.

Author

Hernandez, Rodolfo, Kennedy, Charlotte, Banister, Katie, Goulao, Beatriz, Cook, Jonathan, Sivaprasad, Sobha, Ruth Hogg, Azuara-Blanco, Augusto, Heimann, Heinrich, Dimitrova, Maria, Gale, Richard, Porteous, Mia, Ramsay, Craig R., Chakravarthy, Usha, and Scotland, Graham S.

Abstract

Background/aims To evaluate the cost-effectiveness of non-invasive monitoring tests to detect the onset of neovascular age-related macular degeneration (nAMD) in the unaffected second eye of patients receiving treatment for unilateral nAMD in a UK National Health Service (NHS) hospital outpatient setting. Methods A patient-level state transition model was constructed to simulate the onset, detection, and treatment of nAMD in the second eye. Five index tests were compared: self-reported change in visual function, Amsler test, clinic measured change in visual acuity from baseline, fundus assessment by clinical examination or colour photography, and spectral domain optical coherence tomography (SD-OCT). Diagnosis of nAMD was confirmed by fundus fluorescein angiography (FFA) before prompt initiation of antivascular endothelial growth factor treatment. Quality-adjusted life-years (QALYs) and costs of health and social care were modelled over a 25-year time horizon. Results SD-OCT generated more QALYs (SD-OCT, 5.830; fundus assessment, 5.787; Amsler grid, 5.736, patient's subjective assessment, 5.630; and visual acuity, 5.600) and lower health and social care costs (SD-OCT, £19 406; fundus assessment, £19 649; Amsler grid, £19 751; patient's subjective assessment, £20 198 and visual acuity, £20 444) per patient compared with other individual monitoring tests. Probabilistic sensitivity analysis indicated a high probability (97%-99%) of SD-OCT being the preferred test across a range of cost-effectiveness thresholds (£13 000-£30 000) applied in the UK NHS. Conclusions Early treatment of the second eye following FFA confirmation of SD-OCT positive findings is expected to maintain better visual acuity and health-related quality of life and may reduce costs of health and social care over the lifetime of patients. [ABSTRACT FROM AUTHOR]

Published
2022
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124. Early detection of neovascular age-related macular degeneration: an economic evaluation based on data from the EDNA study

Author

Hernandez, Rodolfo, primary, Kennedy, Charlotte, additional, Banister, Katie, additional, Goulao, Beatriz, additional, Cook, Jonathan, additional, Sivaprasad, Sobha, additional, Hogg, Ruth, additional, Azuara-Blanco, Augusto, additional, Heimann, Heinrich, additional, Dimitrova, Maria, additional, Gale, Richard, additional, Porteous, Mia, additional, Ramsay, Craig R, additional, Chakravarthy, Usha, additional, and Scotland, Graham S, additional

Published
2021
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125. Defining Nonadherence and Nonpersistence to Anti–Vascular Endothelial Growth Factor Therapies in Neovascular Age-Related Macular Degeneration

Author

Okada, Mali, primary, Wong, Tien Yin, additional, Mitchell, Paul, additional, Eldem, Bora, additional, Talks, S. James, additional, Aslam, Tariq, additional, Daien, Vincent, additional, Rodriguez, Francisco J., additional, Gale, Richard, additional, Barratt, Jane, additional, Finger, Robert P., additional, and Loewenstein, Anat, additional

Published
2021
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126. Food fascists: GMO and pesticide manufacturers down and dirty

Author

Gale, Richard and Null, Gary

Subjects
Monsanto Co. -- Customer relations -- Product development, Genetically modified organisms -- Health aspects -- Product development, Animal feeding and feeds -- Health aspects -- Product development, Agricultural chemicals industry -- Customer relations -- Product development, Health
Abstract

After decades of rearing hogs, Danish farmer lb Borup Pedersen was alarmed at the growing incidence of malformations and biological defects among his newborn piglets. Deformities included gaps in piglets' [...]

Published
2015

128. The Percentage Rent Clause: Suggested Contract Language for Leased Auxiliary Operations.

Author

Rose, Edward M. and Gale, Richard N.

Abstract

A college or university thinking of leasing out facilities for an auxiliary activity on campus should consider including a percentage rent provision in the contract, to benefit from increased sales. Issues to consider include definitions and reporting of gross sales, audits of reported sales, and auditing procedures and reporting. (MSE)

Published
1991

132. Ophthalmology research in the UK’s National Health Service: the structure and performance of the NIHR’s Ophthalmology research portfolio

Author

Dawson, Sarah R, Linton, Emma, Beicher, Kris, Gale, Richard, Patel, Praveen, Ghanchi, Faruque, Beresford, Michael W, Poustie, Vanessa, Chakravarthy, Usha, Bourne, Rupert RA, Ashworth, Jane, Bailey, Clare, Downes, Susan, Downey, Louise, George, Sheena, Gottlob, Irene, Hammond, Christopher, Harding, Simon, Jackson, Jonathan, Lotery, Andrew, McKibbin, Martin, Membrey, Luke, Mulholland, Padraig J, Patel, Nishal, Saleh, George M, Sanders, Roshini, Silvestri, Giuliana, Sung, Velota, Varma, Deepali, Votruba, Marcella, Worrell, Emma, Shah, Brinda, Nickson, Ian, Beresford, Michael, Chambers, Emma, Cooper, Sarah, Yelf, Cathy, Hoad, Geraldine, Acton, Michele, Gow, Louise, Broom, Matt, Dickinson, Christine, Mulholland, Padraig, Doug, Manjo, Barry, Robert, and Grp, NIHR Ophthalmology Specialty

Subjects
medicine.medical_specialty, Biomedical Research, business.industry, Specialty, MEDLINE, National health service, Article, State Medicine, United Kingdom, 03 medical and health sciences, Ophthalmology, Improved performance, 0302 clinical medicine, Clinical research, Correspondence, 030221 ophthalmology & optometry, medicine, Research studies, Humans, Portfolio, Observational study, business, 030217 neurology & neurosurgery
Abstract

Purpose-\ud \ud To report on the composition and performance of the portfolio of Ophthalmology research studies in the United Kingdom’s National Institute for Health Research (NIHR) Clinical Research Network (UK CRN).\ud \ud Methods-\ud \ud Ophthalmology studies open to recruitment between 1 April 2010 and 31 March 2018 were classified by: sub-specialty, participant age, gender of Chief Investigator, involvement of genetic investigations, commercial/ non-commercial, interventional/observational design. Frequency distributions for each covariate and temporal variation in recruitment to time and target were analysed.\ud \ud Results-\ud \ud Over 8 years, 137,377 participants were recruited (average of 15,457 participants/year; range: 5485–32,573) with growth by year in proportion of commercial studies and hospital participation in England (76% in 2017/18). Fourteen percent of studies had a genetic component and most studies (82%) included only adults. The majority of studies (41%) enrolled patients with retinal diseases, followed by glaucoma (17%), anterior segment and cataract (13%), and ocular inflammation (6%). Overall, 68% of non-commercial studies and 55% of commercial studies recruited within the anticipated time set by the study and also recruited to or exceeded the target number of participants.\ud \ud Conclusions-\ud \ud High levels of clinical research activity, growth and improved performance have been observed in Ophthalmology in UK over the past 8 years. Some sub-specialties that carry substantial morbidity and a very high burden on NHS services are underrepresented and deserve more patient-centred research. Yet the NIHR and its CRN Ophthalmology National Specialty Group has enabled key steps in achieving the goal of embedding research into every day clinical care.

Published
2018

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