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7. 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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10. 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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11. Risk Factors for Legal Blindness in 237 Japanese Patients with Exogenous Endophthalmitis: A Multicenter Cohort Study from J-CREST.

Author

Yoshimura A, Ishikawa H, Uchida K, Takesue Y, Mori J, Kinoshita T, Morikawa S, Okamoto F, Sawada T, Ohji M, Kanda T, Takeuchi M, Miki A, Kusuhara S, Ueda T, Ogata N, Sugimoto M, Kondo M, Yoshida S, Ogata T, Kimura K, Mitamura Y, Jujo T, Takagi H, Terasaki H, Sakamoto T, Sugisawa T, Komuku-Yamamoto Y, and Gomi F

Subjects
Humans, Retrospective Studies, Male, Risk Factors, Female, Middle Aged, Japan epidemiology, Aged, Adult, Anti-Bacterial Agents therapeutic use, Aged, 80 and over, East Asian People, Endophthalmitis epidemiology, Endophthalmitis microbiology, Endophthalmitis diagnosis, Eye Infections, Bacterial epidemiology, Eye Infections, Bacterial microbiology, Eye Infections, Bacterial diagnosis, Visual Acuity physiology, Blindness etiology, Blindness epidemiology
Abstract

Purpose: We investigated potential risk factors for visual prognosis in Japanese patients with exogenous endophthalmitis., Methods: In this retrospective observational multicenter cohort study, risk factors for legal blindness at 12 weeks after treatment initiation were evaluated based on patient characteristics, initial BCVA, causative events, pathogens, ocular symptoms, duration from symptom onset to initial treatment, and selected treatments., Results: Overall, 23.1% of eyes developed legal blindness. The six risk factors for legal blindness were presence of eye pain, pathogen identification, poor BCVA at the initial visit, longer duration from symptom onset to initial treatment, type of causative event, and type of causative pathogen. Regarding the type of causative pathogen, coagulase-negative staphylococci was associated with a better visual impairment outcome., Conclusion: Exogenous endophthalmitis remains a severe ocular infection; however, it can be managed with rapid treatment, as well as other advances in medical knowledge and technology.

Published
2024
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12. Phase I Study of Tivozanib Eye Drops in Healthy Volunteers and Patients with Neovascular Age-Related Macular Degeneration.

Author

Gomi F, Iida T, Mori R, Horita S, Nakamura H, Nakajima Y, Shiokawa A, and Takahashi K

Abstract

Purpose: To evaluate the safety, pharmacokinetics, and exploratory efficacy of tivozanib eye drops in healthy volunteers and patients with neovascular age-related macular degeneration (nAMD)., Design: This multicenter group-sequential dose escalation phase I study consisted of a placebo-controlled double-masked study of healthy volunteers (cohorts 1 and 2) and an open-label study of patients with nAMD (cohort 3)., Participants: Healthy volunteers: Japanese or White men aged 20 to <50 years. Patients with nAMD with central subfield thickness (CST) ≥300 μm and best-corrected visual acuity score ≥23 letters in the study eye., Methods: In the single-dose cohort of healthy men (cohort 1: steps 1-5), 1 or 2 tivozanib eye drops (30 μL/drop, 5-minute interval; 0.5, 1.0, and 2.0 w/v%) or placebo were administered in 1 eye once. In the multiple-dose cohort of healthy men (cohort 2: steps 1-6), 1 or 2 tivozanib eye drops (0.5, 1.0, and 2.0 w/v%) or placebo were administered 3 times daily in 1 eye for 21 days. In the multiple-dose cohort of patients with nAMD (cohort 3, steps 1-3), 1 or 2 tivozanib eye drops (0.5 and 1.0 w/v%) were administered 3 times daily in 1 affected eye for 21 days., Main Outcome Measures: The safety outcome measures included adverse events (AEs). The pharmacokinetic outcome was serum tivozanib concentration. Among the exploratory efficacy outcomes, CST was evaluated., Results: In total, 40, 48, and 28 participants were enrolled in cohorts 1, 2, and 3, respectively. Serious AEs did not occur in cohorts 1 to 3. The most frequent AE in multiple-dose cohorts was reversible punctate keratitis: placebo arm, 8.3% (healthy men, 1/12); tivozanib arm, 47.2% (healthy men, 17/36) and 14.3% (nAMD, 4/28). Serum tivozanib exposure increased dose-dependently and was similar in healthy men and patients with nAMD. In patients with nAMD, mean CST changes from baseline to day 22 were -27.6 ± 54.88 (0.5 w/v%; 1 drop, 3 times daily), -35.6 ± 49.64 (1.0 w/v%; 1 drop, 3 times daily), and -43.7 ± 55.19 μm (1.0 w/v%; 2 drops, 3 times daily)., Conclusions: Tivozanib eye drops showed a favorable safety profile in healthy Japanese and White men and Japanese patients with nAMD., Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (© 2024 by the American Academy of Ophthalmology.)

Published
2024
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13. Impact of drainage retinotomy on surgical outcomes of retinal detachment: insights from the Japan-Retinal Detachment Registry.

Author

Fukuyama H, Ishikawa H, and Gomi F

Subjects
Humans, Retrospective Studies, Japan epidemiology, Postoperative Complications surgery, Visual Acuity, Vitrectomy, Treatment Outcome, Retinal Detachment surgery
Abstract

We investigated the impact of drainage retinotomy on the outcome of pars plana vitrectomy for repair of rhegmatogenous retinal detachment (RRD). This study was a retrospective observational multicenter study. All patients were registered with the Japan-Retinal Detachment Registry. We analyzed 1887 eyes with RRD that had undergone vitrectomy and were observed for 6 months between February 2016 and March 2017. We compared the baseline characteristics and postoperative outcomes between eyes with and without drainage retinectomy. We then performed propensity score matching using preoperative findings as covariates to adjust for relevant confounders. Of 3446 eyes, 1887 met the inclusion criteria. Among them, 559 eyes underwent vitrectomy with drainage retinotomy, and 1328 eyes underwent vitrectomy without drainage retinotomy. After propensity score matching, each group comprised 544 eyes. There was no significant difference between the two groups in BCVA at 6 months after vitrectomy (0.181 vs. 0.166, P = 0.23), the primary anatomical success rate (6.3% vs. 4.4%, P = 0.22), or the rate of secondary surgery for ERM within 6 months (1.5% vs. 1.3%, P = 1.0). Drainage retinectomy does not increase the risk of decreased postoperative BCVA, surgical failure, or secondary surgery for ERM within six months outcomes., (© 2024. The Author(s).)

Published
2024
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14. Patterns of anti-vascular endothelial growth factor treatment for chorioretinal vascular diseases: Analysis of a nationwide claims database in Japan.

Author

Gomi F, Kawasaki R, Ogura Y, Iwasaki K, Takeshima T, Yamabe M, and Imai K

Abstract

Background: Although intravitreal anti-vascular endothelial growth factor therapy is currently considered the first-line treatment for chorioretinal vascular diseases in Japan, information regarding its treatment pattern is scarce. This study investigated the patterns of anti-vascular endothelial growth factor treatment for chorioretinal vascular diseases., Methods: A health insurance claims database from acute care hospitals was used to estimate treatment intervals and continuation and drop-out rates regarding the anti-vascular endothelial growth factor. Patients aged ≥50 years diagnosed with neovascular age-related macular degeneration or aged ≥18 years diagnosed with diabetic macular edema or retinal vein occlusion were analyzed., Results: Data were included for 76,535, 49,704, and 37,681 patients with neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, respectively; exactly 8,111, 2,283, and 6,896 received the treatment, respectively. The mean and median interval ranges during the maintenance phase by treatment initiation year were 94-100 and 73-80, 111-120 and 98-102, and 97-103 and 87-93 days for neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, respectively, without any trend over time. A tendency to increase the treatment continuation rate was indicated in later years by Kaplan-Meier curves. The drop-out rate in the treatment initiation year (2016) was 32% from 63% (2009), 53% from 69% (2014), and 36% from 47% (2013) for neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, respectively., Conclusions: For all these diseases, the treatment intervals did not change remarkably, and a tendency toward improved treatment continuation was suggested., Competing Interests: Fumi Gomi (FG) and Ryo Kawasaki (RK) report receiving honoraria for advisory board participation from Novartis Pharma K.K. for the current work. FG reports receiving grant support from Santen, lecture fees from Bayer, Senju, Chugai, Santen, and Novartis, and honoraria for advisory board participation from Senju, Kyowa Kirin, and Boehringer Ingelheim; and serves as a director of the Japanese Ophthalmological Society, Japanese Retina and Vitreous Society, and Japanese Ocular Circulation Society, outside the submitted work. RK belonged to an endowed department funded by Topcon until February 2023; reports receiving research funding from Senju, Nanolux, Tamron, and WHILL, consulting fees from Office Future and Nanolux, and honoraria for lectures from Novartis, Bayer, Kowa, Alcon Japan, and Bausch Lomb; and serves as a delegate member of the Japan Epidemiological Association, a councilor member of the Japanese Society of Cardiovascular Disease Prevention and Japanese Society of Artificial Intelligence in Ophthalmology, an assistant secretary-general of the Asia-Pacific Tele-ophthalmology Society, and a research standing committee member of the Asian Pacific Academy of Ophthalmology, outside the submitted work. Yuichiro Ogura reports receiving grant supports from Boehringer Ingelheim and Novartis, personal fees from Bayer, Novartis, Hoya, Kowa, Alcon, Kyoto Drug Discovery & Development, Senju, Iveric Bio, Apellis Pharmaceutical, Chengdu Kanghong Biotechnology, and Chugai, lecture fees from Bayer, Novartis, Santen, Senju, Sanwa Kagaku, Wakamoto, Otsuka, Topcon, and Nikon, and fee for employment from Genentech; and serves as an executive director of the Japanese Ophthalmological Society, the president of the Japanese Retina and Vitreous Society, a director of the Japanese Society of Ophthalmic Diabetology, Japanese Society for Ocular Circulation, Japanese Society for Microcirculation, and Japanese Society for Ocular Pharmacology, and a board member of the Euretina (European Society of Retina Specialist) and Retina World Congress, outside the submitted work. Masaumi Yamabe and Kota Imai are employees of Novartis Pharma K.K., Japan. Kosuke Iwasaki and Tomomi Takeshima are employees of Milliman Inc., which received funding from Novartis Pharma K.K. to perform the analyses and develop the manuscript., (© 2024 Society for Clinical Epidemiology.)

Published
2024
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