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1. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2

Author

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

Published
2024
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4. Heterogeneity in disease activity, frequency of treatments, and visual outcomes among patients with retinal vein occlusion: relationship between injection need and vision with as-needed ranibizumab.

Author

Bhisitkul, Robert B., Campochiaro, Peter A., Blotner, Steven, Quezada-Ruiz, Carlos, Liu, Mimi, and Haskova, Zdenka

Abstract

Background/aims We characterised the relationships between monitoring frequency, ranibizumab injection need and vision in patients receiving as-needed (pro re nata; PRN) ranibizumab for macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in this post-hoc analysis of SHORE and HORIZON. Methods Patients aged 18 years and older with macular oedema due to BRVO/CRVO were included in this analysis. Injection frequency and best-corrected visual acuity (BCVA) were evaluated by PRN injection frequency in the PRN dosing phase (months (M) 7-15) of SHORE and through 12 months of HORIZON. Prespecified PRN re-treatment criteria for each trial were based on protocol-prespecified BCVA and optical coherence tomography outcomes. Results After the initial 7 monthly ranibizumab injections, patients in SHORE gained a mean of 18.3 letters from baseline. Patients randomised to PRN, on average, maintained these gains. However, some patients experienced additional mean gains, whereas others suffered losses (range 4.0 (95% CI 0.7 to 7.3) to -4.6 (95% CI -11.8 to 2.6) letters in patients who received 0 and 6-7 PRN injections, respectively). In BRAVO and CRUISE (lead-in trials), patients experienced mean gains from baseline to M6 (monthly dosing) of 19.3 and 15.0 letters, respectively, with gains maintained with PRN from M6 to M12. However, mean BCVA changes from baseline to M12 varied in HORIZON (range -0.4 (95% CI -2.5 to 1.6) to -3.6 (95% CI -6.2 to -1.0) letters in patients who received zero and six injections, respectively, during the preceding PRN phase of BRAVO and CRUISE). Conclusion The BRVO/CRVO population is heterogenous with a varied response to ranibizumab treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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5. 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

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

Published
2022
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7. TENAYA and LUCERNE

Author

Khanani, Arshad M., primary, Kotecha, Aachal, additional, Chang, Andrew, additional, Chen, Shih-Jen, additional, Chen, Youxin, additional, Guymer, Robyn, additional, Heier, Jeffrey S., additional, Holz, Frank G., additional, Iida, Tomohiro, additional, Ives, Jane A., additional, Lim, Jennifer I., additional, Lin, Hugh, additional, Michels, Stephan, additional, Quezada Ruiz, Carlos, additional, Schmidt-Erfurth, Ursula, additional, Silverman, David, additional, Singh, Rishi, additional, Swaminathan, Balakumar, additional, Willis, Jeffrey R., additional, Tadayoni, Ramin, 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 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, Chao, Daniel, additional, Chaudhry, Nauman, additional, Chee, Caroline, additional, Cheek, Andrew, 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, Vega, Alvaro Fernandez, 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, Sola, Federico Furno, 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, Ulla, Francisco Gomez, additional, Gomi, Fumi, additional, Gonzalez, Victor, additional, Graff, Jordan, additional, Gupta, Sunil, additional, Guthoff, Rainer, 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, 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, Lobo, Rodrigo Montemayor, 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. Wilk, 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, Regillo, Carl, 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, Yzer, Suzanne, 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, Lith-Verhoeven, Janneke Van, additional, Varsanyi, Balazs, additional, Viola, Francesco, 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, Hyeong Gon, additional, Yu, Seung Young, additional, Yurieva, Tatiana, additional, Zambrano, Alberto, additional, Zatorska, Barbara, additional, and Zeolite, Carlos, additional

Published
2024
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10. 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., Khanani, Arshad M., Quezada Ruiz, Carlos, Basu, Karen, Ferrone, Philip J., Brittain, Christopher, Figueroa, Marta S., Lin, Hugh, Holz, Frank G., Patel, Vaibhavi, Lai, Timothy Y.Y., Silverman, David, Regillo, Carl, Swaminathan, Balakumar, Viola, Francesco, Cheung, Chui Ming Gemmy, Wong, Tien Y., Abbey, Ashkan, Abdulaeva, Elmira, Abraham, Prema, Adan Civera, Alfredo, Agostini, Hansjurgen, Alezzandrini, Arturo, Alfaro, Virgil, Almony, Arghavan, Altay, Lebriz, Amini, Payam, Antoszyk, Andrew, Aradi, Etelka, Arias, Luis, Arnold, Jennifer, Asaria, Riaz, Astakhov, Sergei, Astakhov, Yury, Awh, Carl C., Balaratnasingam, Chandra, Banerjee, Sanjiv, Baumal, Caroline, Becker, Matthias, Belfort, Rubens, Bratko, Galina, Bridges, William Z., Brown, Jamin, Brown, David M., Budzinskaya, Maria, Buffet, Sylvia, Burgess, Stuart, Byon, Iksoo, Larsen, Michael, Sørensen, Torben L., Heier, Jeffrey S., Khanani, Arshad M., Quezada Ruiz, Carlos, Basu, Karen, Ferrone, Philip J., Brittain, Christopher, Figueroa, Marta S., Lin, Hugh, Holz, Frank G., Patel, Vaibhavi, Lai, Timothy Y.Y., Silverman, David, Regillo, Carl, Swaminathan, Balakumar, Viola, Francesco, Cheung, Chui Ming Gemmy, Wong, Tien Y., Abbey, Ashkan, Abdulaeva, Elmira, Abraham, Prema, Adan Civera, Alfredo, Agostini, Hansjurgen, Alezzandrini, Arturo, Alfaro, Virgil, Almony, Arghavan, Altay, Lebriz, Amini, Payam, Antoszyk, Andrew, Aradi, Etelka, Arias, Luis, Arnold, Jennifer, Asaria, Riaz, Astakhov, Sergei, Astakhov, Yury, Awh, Carl C., Balaratnasingam, Chandra, Banerjee, Sanjiv, Baumal, Caroline, Becker, Matthias, Belfort, Rubens, Bratko, Galina, Bridges, William Z., Brown, Jamin, Brown, David M., Budzinskaya, Maria, Buffet, Sylvia, Burgess, Stuart, Byon, Iksoo, Larsen, Michael, and Sørensen, Torben L.

Abstract

Background: Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD). Methods: TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300). Findings: Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [−1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [–1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121

Published
2022

11. 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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12. TENAYA and LUCERNE

Author

Khanani, Arshad M., primary, Guymer, Robyn H., additional, Basu, Karen, additional, Boston, Heather, additional, Heier, Jeffrey S., additional, Korobelnik, Jean-François, additional, Kotecha, Aachal, additional, Lin, Hugh, additional, Silverman, David, additional, Swaminathan, Balakumar, additional, Willis, Jeffrey R., additional, Yoon, Young Hee, additional, and Quezada-Ruiz, Carlos, additional

Published
2021
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14. Reply

Author

Heier, Jeffrey S., primary, Singh, Rishi P., additional, Wykoff, Charles C., additional, Csaky, Karl G., additional, Lai, Timothy Y. Y., additional, Loewenstein, Anat, additional, Schlottmann, Patricio G., additional, Paris, Liliana P., additional, Westenskow, Peter D., additional, and Quezada-Ruiz, Carlos, additional

Published
2021
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24. Desgarros retinianos gigantes tratados con vitrectomía calibre 23, abordaje bimanual, sin cerclaje escleral y sin tocar el cristalino.

Author

Quezada-Ruiz, Carlos and Cano-Hidalgo, René Alfredo

Subjects
RETINAL injuries, HEALTH outcome assessment, VITRECTOMY, VITREOUS body surgery, RETINAL detachment
Abstract

Copyright of Cirugía y Cirujanos is the property of Publicidad Permanyer SLU and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2014

25. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2.

Author

Khanani, Arshad M., Kotecha, Aachal, Chang, Andrew, Chen, Shih-Jen, Chen, Youxin, Guymer, Robyn, Heier, Jeffrey S., Holz, Frank G., Iida, Tomohiro, Ives, Jane A., Lim, Jennifer I., Lin, Hugh, Michels, Stephan, Quezada Ruiz, Carlos, Schmidt-Erfurth, Ursula, Silverman, David, Singh, Rishi, Swaminathan, Balakumar, Willis, Jeffrey R., and Tadayoni, Ramin

Subjects
*MACULAR degeneration, *BISPECIFIC antibodies, *CLINICAL trials, *VASCULAR endothelial growth factors, *POLYPOIDAL choroidal vasculopathy
Abstract

To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A. TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials. Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older. Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen. Efficacy analyses included change in best-corrected visual acuity (BCVA) from baseline at 2 years (averaged over weeks 104, 108, and 112) and proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. Safety analyses included ocular adverse events (AEs) in the study eye through study end at week 112. Of 1326 patients treated across TENAYA/LUCERNE, 1113 (83.9%) completed treatment (n = 555 faricimab; n = 558 aflibercept). The BCVA change from baseline at 2 years was comparable between faricimab and aflibercept groups in TENAYA (adjusted mean change, +3.7 letters [95% confidence interval (CI), +2.1 to +5.4] and +3.3 letters [95% CI, +1.7 to +4.9], respectively; mean difference, +0.4 letters [95% CI, −1.9 to +2.8]) and LUCERNE (adjusted mean change, +5.0 letters [95% CI, +3.4 to +6.6] and +5.2 letters [95% CI, +3.6 to +6.8], respectively; mean difference, −0.2 letters [95% CI, −2.4 to +2.1]). At week 112 in TENAYA and LUCERNE, 59.0% and 66.9%, respectively, achieved Q16W faricimab dosing, increasing from year 1, and 74.1% and 81.2%, achieved Q12W or longer dosing. Ocular AEs in the study eye were comparable between faricimab and aflibercept groups in TENAYA (55.0% and 56.5% of patients, respectively) and LUCERNE (52.9% and 47.5% of patients, respectively) through week 112. Treat-and-extend faricimab treatment based on nAMD disease activity maintained vision gains through year 2, with most patients achieving extended dosing intervals. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Machine Learning to Predict Faricimab Treatment Outcome in Neovascular Age-Related Macular Degeneration.

Author

Kikuchi Y, Kawczynski MG, Anegondi N, Neubert A, Dai J, Ferrara D, and Quezada-Ruiz C

Abstract

Purpose: To develop machine learning (ML) models to predict, at baseline, treatment outcomes at month 9 in patients with neovascular age-related macular degeneration (nAMD) receiving faricimab., Design: Retrospective proof of concept study., Participants: Patients enrolled in the phase II AVENUE trial (NCT02484690) of faricimab in nAMD., Methods: Baseline characteristics and spectral domain-OCT (SD-OCT) image data from 185 faricimab-treated eyes were split into 80% training and 20% test sets at the patient level. Input variables were baseline age, sex, best-corrected visual acuity (BCVA), central subfield thickness (CST), low luminance deficit, treatment arm, and SD-OCT images. A regression problem (BCVA) and a binary classification problem (reduction of CST by 35%) were considered. Overall, 10 models were developed and tested for each problem. Benchmark classical ML models (linear, random forest, extreme gradient boosting) were trained on baseline characteristics; benchmark deep neural networks (DNNs) were trained on baseline SD-OCT B-scans. Baseline characteristics and SD-OCT data were merged using 2 approaches: model stacking (using DNN prediction as an input feature for classical ML models) and model averaging (which averaged predictions from the DNN using SD-OCT volume and from classical ML models using baseline characteristics)., Main Outcome Measures: Treatment outcomes were defined by 2 target variables: functional (BCVA letter score) and anatomical (percent decrease in CST from baseline) outcomes at month 9., Results: The best-performing BCVA regression model with respect to the test coefficient of determination (R 2 ) was the linear model in the model-stacking approach with R 2 of 0.31. The best-performing CST classification model with respect to test area under receiver operating characteristics (AUROC) was the benchmark linear model with AUROC of 0.87. A post hoc analysis showed the baseline BCVA and the baseline CST had the most effect in the all-model prediction for BCVA regression and CST classification, respectively., Conclusions: Promising signals for predicting treatment outcomes from baseline characteristics were detected; however, the predictive benefit of baseline images was unclear in this proof-of-concept study. Further testing and validation with larger, independent datasets is required to fully explore the predictive capacity of ML models using baseline imaging data., Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (© 2023 by the American Academy of Ophthalmology.)

Published
2023
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27. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration.

Author

Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, and Quezada-Ruiz C

Abstract

Purpose: To describe the design and rationale of the phase 3 TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) trials that aimed to assess efficacy, safety, and durability of faricimab, the first bispecific antibody for intraocular use, which independently binds and neutralizes both angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A) versus aflibercept in patients with neovascular age-related macular degeneration (nAMD)., Design: Identical, global, double-masked, randomized, controlled, phase 3 clinical trials., Participants: Adults with treatment-naïve nAMD., Methods: These trials were designed to evaluate patients randomized to receive faricimab 6.0 mg up to every 16 weeks after 4 initial every-4-week doses or aflibercept 2.0 mg every 8 weeks after 3 initial every-4-week doses. The initial doses in the faricimab arm were followed by individualized fixed treatment intervals up to week 60, based on disease activity assessment at weeks 20 and 24, guided by central subfield thickness, best-corrected visual acuity (BCVA), and investigator assessment. The primary efficacy end point was BCVA change from baseline averaged over weeks 40, 44, and 48. Secondary end points included the proportion of patients receiving every-8-week, every-12-week, and every-16-week faricimab and anatomic outcomes. Safety outcomes included incidence and severity of ocular and nonocular adverse events. From week 60, faricimab-treated patients followed a personalized treatment interval (PTI), a novel protocol-driven treat-and-extend regimen with interval adjustment from every 8 weeks to every 16 weeks based on individualized treatment response measured by anatomic criteria, functional criteria, and investigator assessment of patients' disease activity., Main Outcome Measures: Rationale for trial design and PTI approach., Results: The TENAYA and LUCERNE trials were the first registrational trials in nAMD to test fixed dosing regimens up to every 16 weeks based on patients' disease activity in year 1 and incorporate a PTI paradigm during year 2. The PTI approach was designed to tailor treatment intervals to individual patient needs, to reflect clinical practice treatment practice, and to reduce treatment burden., Conclusions: The innovative trial design rationale for the TENAYA and LUCERNE trials included maximizing the benefits of angiopoietin-2 blockade through dosing up to every 16 weeks and PTI regimens based on patients' disease activity while fulfilling health authority requirements for potential registrational efforts., (© 2021 by the American Academy of Ophthalmology.)

Published
2021
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28. [Giant retinal tears treated with lens sparing, bimanual 23 g vitrectomy without scleral buckle].

Author

Quezada-Ruiz C and Cano-Hidalgo RA

Subjects
Eye Injuries surgery, Humans, Myopia complications, Retinal Degeneration complications, Retinal Detachment complications, Retinal Detachment surgery, Retinal Perforations etiology, Retinal Perforations pathology, Retrospective Studies, Scleral Buckling, Treatment Outcome, Versicans deficiency, Visual Acuity, Wounds, Nonpenetrating surgery, Retinal Perforations surgery, Vitrectomy methods
Abstract

Background: A giant retinal tear is defined as a full thickness break in the neurosensory retina that extends circumferentially for 3 or more clock hours around the retina in the presence of a posterior vitreous detachment. It is one of the more complex surgical scenarios that a retina surgeon can face. There is no consensus on the ideal surgical technique; however, the "traditional" approach has been to perform a combined procedure including lensectomy, scleral buckle and vitrectomy., Objective: To report the outcome over 2 years of five patients with giant retinal tears managed with lens sparing, bimanual 23-gauge vitrectomy without scleral buckle., Methods: Retrospective analysis of patients with giant retinal tears managed with lens sparing, bimanual 23-gauge vitrectomy without scleral buckle. Included in the analysis were age, lens status, etiology and size of the tear, pre- and postoperative visual acuity, anatomic success, tamponade used, laser or criopexy where recorded., Results: Three patients had high myopia, one secondary to blunt trauma and one with Wagner-Stickler syndrome were included in the analysis. The size of the tear varied from 120-280°. Anatomic success was achieved in all patients. One patient developed proliferative vitreoretinopathy and was re-operated and the retina remained attached., Conclusions: In this group of selected patients, lens-sparing bimanual 23-gauge vitrectomy without scleral buckle seems a safe and effective option in the management of retinal detachment associated with giant retinal tears. Further prospective and comparative studies are warranted to establish the role of this technique in the treatment of patients with this complex pathology.

Published
2014

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