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3. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial

Author

Abraham, Prema, Aderman, Christopher, Akiyama, Kunihiko, Alfaro, Daniel V., Ali, Fareed A., Amini, Payam, Anzalotta, Andres Emanuelli, Bátor, György, Batlle, Ivan, Berger, Adam, Bhandari, Ramanath, Bridges, William, Brinkmann, Christian, Brown, Jamin, Burgess, Stuart, Calzada, Jorge, Capone Jr., Antonio, Cervena, Dana, Charles, Steven, Chaudhry, Nauman, Chow, David, Clark, W. Lloyd, Conrad III, Paul, Cunningham, Matthew, Dadgostar, Hajir, Dessouki, Amr, Deupree, Dana, Devine, Christopher, Eichenbaum, David, Ernest, Jan, Feltgen, Nicolas, Fenberg, Moss, Ferrone, Philip, Frenkel, Ronald, Friedman, Scott, Gasperini, Julie, Gerstenblith, Adam, Ghorayeb, Ghassan, Giunta, Michel, Goff, Mitchell, Golas, Liliya, Googe Jr., Joseph M., Goren Fein, Jordana, Hagedorn, Curtis, Hagiwara, Akira, Hahn, Paul, Hairston, Richard, Handza, Jason, Hau, Vivienne, Hayashi, Ken, Heier, Jeffrey, Hershberger, Vrinda, Higgins, Patrick, Hirano, Yoshio, Honda, Shigeru, Ikegami, Yasuko, Ishida, Yuichiro, Ishikawa, Isao, Ishii, Kiyoshi, Jablon, Eric P., Jain, Atul, Kaji, Yuichi, Kapoor, Kapil, Kerényi, Ágnes, Kimura, Kazuhiro, Kishino, Genichiro, Kiss, Katalin, Kitaoka, Takashi, Klancnik, James M., Kobayashi, Namie, Kogo, Jiro, Korda, Vladimir, Kruger, Erik, Kusuhara, Sentaro, Lara, Wilfredo, Laud, Ketan, Lee, Seong, Luu, James, Marcus, Dennis, Mein, Calvin, Meleth, Annal, Milibák, Tibor, Mitamura, Yoshinori, Murata, Toshinori, Noge, Sumiyo, Onoe, Hajime, Osher, James, Papp, András, Parschauer, Justin, Patel, Sugat, Patel, Sunil, Pezda, Matthew, Pirouz, Ashkan, Prasad, Pradeep, Punjabi, Omar, Rao, Llewelyn, Roe, Richard, Schadlu, Ramin, Schneider, Eric, Shah, Ankur, Shah, Milan, Shah, Sandeep, Shah, Sumit, Sharma, Ashish, Sheth, Veeral, Shimura, Masahiko, Singerman, Lawrence, Spital, Georg, Stoltz, Robert, Suan, Eric, Suzuma, Kiyoshi, Takahashi, Hidenori, Takamura, Yoshihiro, Takeuchi, Masaru, Tan, Jeffrey, Thomas, Benjamin, Tóth,-Molnár, Edit, Ueda, Tetsuo, Ushida, Hiroaki, Vajas, Attila, Varma, Deepali, Varsányi, Balázs, Veith, Miroslav, Weber, Pamela, Wee, Raymond, Williams, Geoff, Yamada, Haruhiko, Yonekawa, Yoshihiro, Yoshida, Shigeo, Brown, David M, Boyer, David S, Do, Diana V, Wykoff, Charles C, Sakamoto, Taiji, Win, Peter, Joshi, Sunir, Salehi-Had, Hani, Seres, András, Berliner, Alyson J, Leal, Sergio, Vitti, Robert, Chu, Karen W, Reed, Kimberly, Rao, Rohini, Cheng, Yenchieh, Sun, Wei, Voronca, Delia, Bhore, Rafia, Schmidt-Ott, Ursula, Schmelter, Thomas, Schulze, Andrea, Zhang, Xin, Hirshberg, Boaz, Yancopoulos, George D, and Sivaprasad, Sobha

Published
2024
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10. Optimization of individualized faricimab dosing for patients with diabetic macular edema: Protocol for the SWAN open-label, single-arm clinical trial.

Author

Hirano, Takao, Murata, Toshinori, Nakao, Shintaro, Shimura, Masahiko, Nozaki, Miho, Suzuma, Kiyoshi, Nagaoka, Taiji, Sugimoto, Masahiko, Takamura, Yoshihiro, Murakami, Tomoaki, Iwasaki, Keisuke, Tsujimura, Jun, and Yoshida, Shigeo

Subjects
VISION, MACULAR edema, VISION disorders, PEOPLE with diabetes, CAREGIVERS
Abstract

Purpose: In patients with diabetic macular edema (DME) from YOSEMITE/RHINE, dual angiopoietin-2/vascular endothelial growth factor-A (VEGF-A) inhibition with faricimab resulted in visual/anatomic improvements with extended dosing. The SWAN trial (jRCTs031230213) will assess the efficacy, durability, and safety of faricimab during the treatment maintenance phase in patients with DME using a treat-and-extend (T&E)-based regimen adapted to clinical practice and the characteristics of patients achieving extended dosing intervals. Methods: SWAN is a 2-year, open-label, single-arm, interventional, multicenter trial enrolling adults with center-involving DME. All patients will receive three initial faricimab 6.0 mg doses every 4 weeks (Q4W). From week 12 onwards, in patients without active DME, dosing intervals will be extended in 8-week increments up to Q24W. In contrast, patients with active DME (central subfield thickness [CST] >325 μm and intraretinal fluid [IRF] or subretinal fluid [SRF] resulting in vision loss/disease aggravation) will receive a dose within a day and the dosing interval will be shortened by 4 weeks to a minimum of Q8W relative to the previous dosing interval. Recruitment commenced in August 2023 across a planned 16 sites in Japan. Results: The primary endpoint is change in best-corrected visual acuity (BCVA) from baseline at 1 year (averaged over weeks 52, 56, and 60). Key secondary endpoints include: change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire scores over time; proportion of patients with BCVA (decimal visual acuity) ≥0.5, ≥0.7, ≥1.0, or ≤0.1; proportion of patients with absence of DME, and IRF and/or SRF over time. Safety endpoints include incidence/severity of ocular/nonocular adverse events. Conclusions: The SWAN trial is expected to provide evidence to support individualized faricimab dosing regimens, with the potential to reduce the burden of frequent treatments on patients, caregivers, and healthcare systems. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Identification of genes contributing to attenuation of rat model of galactose‐induced cataract by pyruvate.

Author

Masuda, Fuuga, Inami, Mayumi, Takamura, Yoshihiro, Inatani, Masaru, and Oki, Masaya

Subjects
LABORATORY rats, CATARACT, OXIDATIVE stress, FUNCTIONAL analysis, TREATMENT effectiveness, GALACTOSE, PYRUVATES
Abstract

Cataracts are a disease that reduces vision due to opacity formation of the lens. Diabetic cataracts occur at young age and progress relatively quickly, so the development of effective treatment has been awaited. Several studies have shown that pyruvate inhibits oxidative stress and glycation of lens proteins, which contribute to onset of diabetic cataracts. However, detailed molecular mechanisms have not been revealed. In this study, we attempted to reduce galactose‐induced opacity by pyruvate with rat ex vivo model. Rat lenses were extracted and cultured in galactose‐containing medium to induce lens opacity. After opacity had developed, continued culturing with pyruvate in the medium resulted in a reduction of lens opacity. Subsequently, we conducted microarray analysis to investigate the genes that contribute to the therapeutic effect. We performed quantitative expression measurements using RT‐qPCR for extracted genes that were upregulated in cataract‐induced lenses and downregulated in pyruvate‐treated lenses, resulting in the identification of 34 candidate genes. Functional analysis using the STRING database suggests that metallothionein‐related factors (Mt1a, Mt1m, and Mt2A) and epithelial‐mesenchymal transition‐related factors (Acta2, Anxa1, Cd81, Mki67, Timp1, and Tyms) contribute to the therapeutic effect of cataracts. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Intraocular Pressure-Lowering Effect of Intraocular Lens Refixation in Patients with Elevated Intraocular Pressure Due to Intraocular Lens Subluxation.

Author

Iwasaki, Kentaro, Komori, Ryohei, Arimura, Shogo, Takamura, Yoshihiro, and Inatani, Masaru

Subjects
PARS plana, OCULAR hypertension, INTRAOCULAR pressure, INTRAOCULAR lenses, SURGICAL complications, VITRECTOMY, TRABECULECTOMY
Abstract

Background and Objectives: To evaluate the surgical outcomes of intraocular lens (IOL) refixation with vitrectomy in patients with elevated intraocular pressure (IOP) due to IOL subluxation. Materials and Methods: Patients with elevated IOP due to IOL subluxation who had undergone IOL refixation with vitrectomy between 1 June 2013 and 31 December 2023 were retrospectively evaluated. The primary outcome measure was surgical success or failure. Surgical success was defined as a reduction of ≥20% in the preoperative IOP or IOP ≤ 21 mmHg (criterion A), IOP ≤ 18 mmHg (criterion B), or IOP ≤ 15 mmHg (criterion C). Reoperation, loss of light perception, and hypotony were considered as surgical failure. The IOP, number of glaucoma medications used, postoperative complications, and visual acuity were evaluated as the secondary outcomes. The surgical outcomes were compared between the glaucoma and ocular hypertension (OH) groups. Results: At 12 months postoperatively, the probability of success was 72.5%, 54.1%, and 28.4% using criterion A, B, and C, respectively, and the mean IOP and mean number of glaucoma medications used had decreased significantly (p < 0.01 and p = 0.03, respectively). Furthermore, the cumulative success rate was significantly higher in the OH group than in the glaucoma (100% vs. 47.4%; p < 0.01) when using criterion A. Additional glaucoma surgery was required only in the glaucoma group. Conclusions: IOL refixation surgery significantly decreases the IOP and number of glaucoma medications required in patients with elevated IOP due to IOL subluxation. Thus, IOL refixation surgery alone without glaucoma surgery might be effective as the primary procedure in such patients. [ABSTRACT FROM AUTHOR]

Published
2024
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19. Characterization of the visually impaired patients with diabetes mellitus in Japan.

Author

Sugihara, Yuka, Takamura, Yoshihiro, Yamada, Yutaka, Morioka, Masakazu, Gozawa, Makoto, Kato, Kumiko, Hirano, Takao, Murao, Fumiko, Shimizu, Miho, Kusuhara, Sentaro, Murakami, Tomoya, Takenaka, Yuki, Okabe, Naoko, Jujo, Tatsuya, Terasaki, Hiroto, Nagasato, Daisuke, Dong, Zhenyu, Yoshida, Shigeo, Ogura, Shuntaro, and Yasuda, Kanako

Subjects
*DIABETIC retinopathy, *DIABETES, *PEOPLE with diabetes, *PEOPLE with visual disabilities, *HEALTH facilities, *VISION disorders
Abstract

Aims/Introduction: To conduct a multicenter survey of visually impaired patients with diabetes mellitus (DM) and to identify the physical and ocular characteristics that lead to blindness in Japan. Materials and Methods: Visually impaired patients with diabetes mellitus in Japan were divided into blind and low‐vision groups according to the World Health Organization classification. Data on parameters related to diabetes mellitus and ocular complications in the right and left eyes were collected from 19 highly advanced medical facilities and compared between the two groups. Results: Among 408 visually impaired persons (blind group: 257, low‐vision group: 151), 72.1% were under 70 years of age. The rates of neovascular glaucoma (NVG) (right eye, P = 0.041; left eye, P = 0.0031) or proliferative diabetic retinopathy (PDR) (right eye: P = 0.014, left eye: P = 0.0047) and the rate of proliferative membrane beyond half of the retinal area (right eye: P = 0.0263, left eye: P = 0.037) were significantly higher in the blind group. The direct cause of visual impairment was retinal atrophy, common in both groups. Neovascular glaucoma and diabetic macular edema were equally prevalent in the blind and low‐vision groups, respectively. Conclusions: In Japan, blind patients with diabetes mellitus are characterized by severe conditions such as neovascular glaucoma and progressive proliferative diabetic retinopathy upon their initial visit to an advanced care facility. These results highlight the importance of monitoring retinopathy through regular ophthalmological examinations, internal medicine, and appropriate therapeutic intervention. [ABSTRACT FROM AUTHOR]

Published
2024
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32. Incidence of endophthalmitis after intravitreal injection of an anti-VEGF agent with or without topical antibiotics

Author

Morioka, Masakazu, Takamura, Yoshihiro, Nagai, Kazuki, Yoshida, Shigeo, Mori, Junya, Takeuchi, Masaru, Sawada, Tomoko, Sone, Kumiko, Fukuyama, Hisashi, Kusuhara, Sentaro, Yasukawa, Tsutomu, Murakami, Tomoya, Tabuchi, Hitoshi, Nagasato, Daisuke, Hirano, Takao, Ueda, Tetsuo, Jujo, Tatsuya, Sasajima, Hirofumi, Mitamura, Yoshinori, Ishikawa, Kunihiro, and Inatani, Masaru

Published
2020
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39. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial

Author

Brown, David M, Boyer, David S, Do, Diana V, Wykoff, Charles C, Sakamoto, Taiji, Win, Peter, Joshi, Sunir, Salehi-Had, Hani, Seres, András, Berliner, Alyson J, Leal, Sergio, Vitti, Robert, Chu, Karen W, Reed, Kimberly, Rao, Rohini, Cheng, Yenchieh, Sun, Wei, Voronca, Delia, Bhore, Rafia, Schmidt-Ott, Ursula, Schmelter, Thomas, Schulze, Andrea, Zhang, Xin, Hirshberg, Boaz, Yancopoulos, George D, Sivaprasad, Sobha, Abraham, Prema, Aderman, Christopher, Akiyama, Kunihiko, Alfaro, Daniel V., Ali, Fareed A., Amini, Payam, Anzalotta, Andres Emanuelli, Bátor, György, Batlle, Ivan, Berger, Adam, Bhandari, Ramanath, Bridges, William, Brinkmann, Christian, Brown, Jamin, Burgess, Stuart, Calzada, Jorge, Capone Jr., Antonio, Cervena, Dana, Charles, Steven, Chaudhry, Nauman, Chow, David, Clark, W. Lloyd, Conrad III, Paul, Cunningham, Matthew, Dadgostar, Hajir, Dessouki, Amr, Deupree, Dana, Devine, Christopher, Eichenbaum, David, Ernest, Jan, Feltgen, Nicolas, Fenberg, Moss, Ferrone, Philip, Frenkel, Ronald, Friedman, Scott, Gasperini, Julie, Gerstenblith, Adam, Ghorayeb, Ghassan, Giunta, Michel, Goff, Mitchell, Golas, Liliya, Googe Jr., Joseph M., Goren Fein, Jordana, Hagedorn, Curtis, Hagiwara, Akira, Hahn, Paul, Hairston, Richard, Handza, Jason, Hau, Vivienne, Hayashi, Ken, Heier, Jeffrey, Hershberger, Vrinda, Higgins, Patrick, Hirano, Yoshio, Honda, Shigeru, Ikegami, Yasuko, Ishida, Yuichiro, Ishikawa, Isao, Ishii, Kiyoshi, Jablon, Eric P., Jain, Atul, Kaji, Yuichi, Kapoor, Kapil, Kerényi, Ágnes, Kimura, Kazuhiro, Kishino, Genichiro, Kiss, Katalin, Kitaoka, Takashi, Klancnik, James M., Kobayashi, Namie, Kogo, Jiro, Korda, Vladimir, Kruger, Erik, Kusuhara, Sentaro, Lara, Wilfredo, Laud, Ketan, Lee, Seong, Luu, James, Marcus, Dennis, Mein, Calvin, Meleth, Annal, Milibák, Tibor, Mitamura, Yoshinori, Murata, Toshinori, Noge, Sumiyo, Onoe, Hajime, Osher, James, Papp, András, Parschauer, Justin, Patel, Sugat, Patel, Sunil, Pezda, Matthew, Pirouz, Ashkan, Prasad, Pradeep, Punjabi, Omar, Rao, Llewelyn, Roe, Richard, Schadlu, Ramin, Schneider, Eric, Shah, Ankur, Shah, Milan, Shah, Sandeep, Shah, Sumit, Sharma, Ashish, Sheth, Veeral, Shimura, Masahiko, Singerman, Lawrence, Spital, Georg, Stoltz, Robert, Suan, Eric, Suzuma, Kiyoshi, Takahashi, Hidenori, Takamura, Yoshihiro, Takeuchi, Masaru, Tan, Jeffrey, Thomas, Benjamin, Tóth, Edit, -Molnár, Ueda, Tetsuo, Ushida, Hiroaki, Vajas, Attila, Varma, Deepali, Varsányi, Balázs, Veith, Miroslav, Weber, Pamela, Wee, Raymond, Williams, Geoff, Yamada, Haruhiko, Yonekawa, Yoshihiro, and Yoshida, Shigeo

Abstract

A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO.

Published
2024
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40. TRAFFIC ACCIDENT–RELATED OPEN GLOBE INJURIES

Author

Okamoto, Yoshifumi, Morikawa, Shohei, Okamoto, Fumiki, Mitamura, Yoshinori, Ishikawa, Hiroto, Ueda, Tetsuo, Sakamoto, Taiji, Sugitani, Kazuhiko, Sawada, Osamu, Mori, Junya, Takamura, Yoshihiro, and Oshika, Tetsuro

Published
2019
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46. Anti-VEGF Monotherapy versus Combined Anti-VEGF and Endpoint Management Laser for Diabetic Macular Edema (END-DME Study)

Author

Nozaki, Miho, primary, Wong, Ian Y, additional, Kawasaki, Ryo, additional, Lee, Joo Eun, additional, Takamura, Yoshihiro, additional, Lee, Ji Eun, additional, Yoshida, Shigeo, additional, Shin, Jae Pil, additional, Kida, Teruyo, additional, Chang, Woohyok, additional, Tsuiki, Eiko, additional, Noma, Hidetaka, additional, and Suzuma, Kiyoshi, additional

Published
2022
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49. Impact of the COVID-19 Pandemic on Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Japan

Author

Komori, Ryohei, primary, Takamura, Yoshihiro, additional, Yamada, Yutaka, additional, Morioka, Masakazu, additional, Matsubara, Hisashi, additional, Hirano, Takao, additional, Mitamura, Yoshinori, additional, Shimizu, Miho, additional, Kusuhara, Sentaro, additional, Murakami, Tomoya, additional, Nihei, Ryotaro, additional, Ueda, Tetsuo, additional, Kunikata, Hiroshi, additional, Jujo, Tatsuya, additional, Terasaki, Hiroto, additional, Nagasato, Daisuke, additional, Noda, Kousuke, additional, Osaka, Rie, additional, Nagai, Kazuki, additional, Yoshida, Shigeo, additional, Nozaki, Miho, additional, Noma, Hidetaka, additional, Ishigooka, Gaku, additional, Takahashi, Aya, additional, Sawada, Osamu, additional, Kimura, Kazuhiro, additional, and Inatani, Masaru, additional

Published
2022
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