Citations 2
Donor Diabetes and 1-Year Descemet Membrane Endothelial Keratoplasty Success Rate
Price, Francis W. , Szczotka‐Flynn, Loretta , Bauza, Colleen , Reed, Zachariah W., Arafah, Baha M. , Greiner, Mark A. , Johnson, Paula, Keeler, Devon B., Pramanik, Sudeep, Soper, Mark, Terry, Mark A., Titus, Michael S. , Verdier, David D. , Kollman, Craig, Lass, Jonathan H. , Lass, Jonathan H., Group, Diabetes Endothelial Keratoplasty Study, Gang, Anjulie, Hall, Taylor, Lynn, A. G., Cole, Shawna, Phelps, Derek, Baratz, Keith H. , Hardtke, Elainey, Treichel, Emily J., Hood, Christopher , Nallasamy, Nambi , Verkade, Angela , Jones, Kristin, Shapiro, Jeremy, Leavy, Lisa, Sinkey, Chris, Tenkman, Lawrence R., Gordon, DJ, Ketcherside, Christopher, Fox, Jenni, Coonfield, Kristy, Vislisel, Jesse M., Sharma, Yogi, Young, Angela M. , Schoenberg, Evan, Kelly, Sharra, Huffman, James L. , Sears, Melinda, Stone, Merisa, Phillips, Paul, Maloney, Charlene, Jun, Albert S. , Maria, Christina, Boyce, Michelle, Kam, Yong, Crosser, Vicki, Chen, Jessica , Straiko, Michael D., Bauer, Alex, Croasdale, Christopher, Brown, Gayle Waldheim, Veldman, Peter B., Evans, Que, Majmudar, Parag A., Epstein, Rachel , Vaidya, N. N., Nykaza, Jim, Venkateswaran, Nandini, Ayres, Brandon D. , Haught, Drew Monteleone, Prasad, Elizabeth, Toti, Gwen, Wier, Jim, Brandsdorfer, Ari, Pape, Denise, Hansen, Mark D., Hardten, David R., Reeves, Sherman W., Dreyer, Allison, Mack, Megan, Hamill, Mark, Nguyen, Jessica , Stanfield, Ryan, Greenwood, Michael , Ernst, Lindsay, Risbrudt, Nick, Saville, Alyson, Castaneda, Leslie, Torres, Nidia, Potts, Luke B. , Alexander, Jamie, Rinn, Jennifer, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Sica, Chris, Buckman, Natalie, Ansin, Amy, Clover, Jameson , Pivoney, Charles, Vizzerra, Anthony, Elbanhawy, Lindsey, Mullins, Monica, Statz, Brianne, Fout, Elizabeth, Drury, Donna, Tavolazzi, Trisha, Lass, Jonathan, Lass, Jonathan, Richards, Leslie, Raghupathy, Sangeetha, Spruill, Rashad, Bauza, Colleen, Beck, Roy, Garrett, Kaitlyn, Reed, Zachariah, Benetz, Beth Ann , Lê, Jimmy T. , Redford, Maryann , Arafah, Baha, Greiner, Mark, Keeler, Devon, Monnier, Vincent M. , Titus, Michael, Verdier, David, Velhuisen, Paul Van, Hawkins, Barbara S., Macsai, Marian S., Patel, Sanjay, Mian, Shahzad I. , Pramanik, Sudeep , Price, Francis, Terry, Mark, Sell, David, Gabrielson, Deanna, Barton, Glenn, Bear, Andrew, Das, Pravamaya, Dawson, Lauren, Dingess, Ryan, Madere, Mark, Wadleigh, Garth, Price, Marianne O. , Mian, Shahzad I. , Patel, Sanjay V. , Pramanik, Sudeep, Titus, Michael S., Beck, Roy W. , Lass, Jonathan H., Group, Diabetes Endothelial Keratoplasty Study, Lynn, Ashlyn, Cole, Shawna, Phelps, Derek, Hardtke, Elainey, Hood, Christopher, Shapiro, Jeremy, Sáles, Christopher S. , Leavy, Lisa, Gordon, DJ, Fox, Jenni, Coonfield, Kristy, Young, Angela, Schoenberg, Evan, Kelly, Sharra, Huffman, James, Sears, Melinda, Stone, Merisa, Srikumaran, Divya S. , Daoud, Yassine J. , Eghrari, Allen Omid , Ali, Muhammad , Crosser, Vicki, Croasdale, Christopher, Brown, Gayle Waldheim, Evans, Que, Epstein, Rachel H. , Nykaza, Jim, Jurkunas, Ula V. , Cheung, Michael, Wier, Jim, Brandsdorfer, Ari, Pape, Denise, Mack, Megan, Hamill, M. Bowes, Nguyen, Jessica, Koo, Ellen H. , Stanfield, Ryan, Risbrudt, Nick, Saville, Alyson, Omar, Ahmed F. , Castaneda, Leslie, Torres, Nidia, Bokosky, John, Cardenas, Ilina, Murphy, Doreen, Priebe, Kinsey, Schmidt, Gregory A. , Elbanhawy, Lindsey, Statz, Brianne, Tavolazzi, Trisha, Lass, Jonathan, Lass, Jonathan, Richards, Leslie, Spruill, Rashad, Bauza, Colleen, Beck, Roy, McCarthy, Chris, Reed, Zachariah, Arafah, Baha, Greiner, Mark, Titus, Michael, Verdier, David, Velhuisen, Paul Van, Aleppo, Grazia , Bateman-House, Alison , Tu, Elmer Yuchen , Patel, Sanjay, Price, Francis, Terry, Mark, Sell, David, Barton, Glenn, Das, Pravamaya, Dingess, Ryan, Madere, Mark, Sengupta, Partha Pratim , Wadleigh, Garth
JAMA Ophthalmology | October 17, 2025 | Volume: 143 | Issue: 12 | Pages: 1043
10.1001/jamaophthalmol.2025.4253
Importance If the success of Descemet membrane endothelial keratoplasty (DMEK) is not affected by whether the donor has diabetes, then the donor pool should expand. Objective To determine whether the 1-year DMEK success rate is affected by the presence of diabetes in the donor. Design, Setting, and Participants This was a multicenter, double-masked, randomized clinical trial conducted from February 2022 to July 2025 at 28 clinical sites (46 surgeons), with donor corneas provided by 13 eye banks in the US. Included in the study were individuals undergoing low to moderate risk DMEK (95% for Fuchs endothelial corneal dystrophy). Study data were analyzed from April to September 2025. Intervention DMEK performed with a cornea from a donor without or with diabetes, assigned using a minimization procedure (comparable with randomization) to achieve an approximate 2:1 distribution, respectively. Main Outcomes and Measures Graft success at 1 year Results A total of 1097 individuals (1421 study eyes; median [IQR] age, 71 [66-76] years; 631 female [57.5%]) were included in the study. The 1-year cumulative probability of graft success was 96.3% (95% CI, 95.0%-97.5%) among 912 study eyes (64.2%) receiving tissue from donors without diabetes and 97.1% (95% CI, 95.5%-98.4%) among 509 study eyes (35.8%) receiving tissue from donors with diabetes (difference between groups = 0.7 percentage points; 95% CI, −1.2 to 2.6; P = .63). The 1-year cumulative probability of graft success was 96.5% (95% CI, 93.6%-98.9%) in the mild donor diabetes severity subgroup (n = 173) and 97.3% (95% CI, 95.4%-98.8%) in the moderate to severe donor diabetes severity subgroup (n = 336), using a diabetes severity rating scale based on medical history. The rates of primary donor failure, early failure related to surgical complications, and subsequent failure were as follows: 2.5% (23 of 912), 0.7% (6 of 912), and 0.3% (3 of 912), respectively, in recipients of tissue from a donor without diabetes, and 2.6% (13 of 509), 0.4% (2 of 509), and 0%, respectively, among recipients of tissue from a donor with diabetes. There were no failures due to graft rejection. Conclusions and Relevance The 1-year success rate in eyes undergoing DMEK with successfully prepared tissue was very high regardless of donor diabetes status. These results, supported by the separately reported finding that endothelial cell loss and cornea morphometry after 1 year were not affected by donor diabetes status, provide strong support for having no restrictions on the use of tissue from donors with diabetes for DMEK. Trial Registration ClinicalTrials.gov Identifier: NCT05134480
Adjuvant nab -Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial
Tempero, Margaret A. , Pelzer, Uwe , Oh, Do‐Youn , Li, Chung‐Pin , Tortora, Giampaolo , Chang, Heung-Moon, Lopez, Charles D. , Bekaii‐Saab, Tanios , Ko, Andrew H. , Santoro, Armando , Noel, Marcus Smith , Dean, Andrew , Riess, Hanno, Philip, Philip, Moore, Malcolm J. , Goldstein, David , Ferrara, Stefano, Bruchec, Yvan Le, Lu, Brian , Epstein, Richard A. , Vasey, Paul L., Shapiro, Jeremy, Burge, Matthew , Chua, Yu Jo , Harris, Marion , Prager, Gerald W. , Dittrich, Christian , Längle, Friedrich, Philipp‐Abbrederis, Kathrin, Greil, Richard , Stöger, Herbert, Girschikofsky, Michael , Kuehr, Thomas, Laethem, Jean–Luc Van, Laurent, Stéphanie , Ko, Yoo Joung, Dowden, Scot, Kavan, Petr , Tehfe, Mustapha Édouard, Kubala, Eugen, Kohoutek, Milan, Yilmaz, Mette, Parner, Vibeke K., Salminen, Tapio , Soveri, Leena‐Maija , Korkeila, Eija, Taı̈eb, Julien , Artru, Pascal , Guimbaud, Rosine , Turpin, Antony, Kunzmann, Volker , Kreth, Florian, Oettle, Helmut, Karthaus, Meinolf , Folprecht, Gunnar , Kullmann, Frank , Reiser, Marcel , Heinemann, Volker , Wörns, Marcus‐Alexander , Schulz, H. , Garlipp, Benjamin , Chan, Lam Stephen, Juhász, Balázs , Landherr, László, Pintér, Tamás , Kahán, Zsuzsanna , McDermott, Raymond, Power, Derek G. , Siena, Salvatore, Milella, Michèle , Bagalá, Cinzia, Roila, Fausto, Fanello, Silvia, Wilmink, Johanna W. , Groot, Jan Willem de, Creemers, G.J., Rodrigues, Tânia , Tai, David , Mercadé, T. Macarulla, Medina, Manuel Hidalgo, Mena, Alfredo Carrato, Santasusana, Joan Maurel, Oncala, Maria Jose Flor, Martín, Carlos Gómez , Muñoz, Andrés, García, Ruth Vera, Alés, Inmaculada, Rivera, Fernando , Sastre, Javier , Wu, Cheng‐Chung, Tien, Yu‐Wen , Chan, De-Chuan , Hwang, Tsann‐Long , Evans, Jeffry, Wadsley, Jonathan , Chiorean, E. Gabriela , Bendell, Johanna C. , Kindler, Hedy L. , Fernando, Nishan H., Beg, Muhammad Shaalan , LoConte, Noelle K. , Posey, James , Malhotra, Rajat, Sohal, Davendra , Brenner, Warren, Womack, Mark, Seth, Rahul , lyer, Renuka, Bahary, Nathan , Marsh, Robert , Chua, Cynthia C., Reeves, J. N. , Manji, Gulam A. , Sahai, Vaibhav , Messersmith, Wells A. , Zakari, Ahmed, Bullock, Andrea J. , Musher, Benjamin , Kim, Edward , Bajor, David J., Huyck, Tim, Hatoum, Hassan , Xiong, Henry, Pasche, Boris , Lacy, Jill , Olowokure, Olugbenga, Cohn, Allen Lee, Richards, Donald , Martin, Robert C.G. , Paulson, Andrew Scott , Fanta, Paul T. , Krishnamurthi, Smitha , Fuloria, Jyotsna, McDermott, Ray , Turpin, Anthony , O'Reilly, Eileen M , Winter, Jordan Michael , Oh, Do-Youn , Li, Chung-Pin , Tortora, Giampaolo , Bekaii-Saab, Tanios S , Santoro, Armando , Park, Joon Oh , Dean, Andrew , Van Cutsem, Eric , Berlin, Jordan D. , Tabernero, Josep , Biankin, Andrew V , LoConte, Noelle , Taieb, Julien , McDermott, Ray , Prager, Gerald W , Sahai, Vaibhav , O’Reilly, Eileen M. , Frassineti, Giovanni Luca , Shan, Yan‐Shen , Cutsem, Eric Van , Tabernero, Josep , Li, Mingyu , Zhang, George , Biankin, Andrew V. , Reni, Michele , Vasey, Paul, Pavlakis, Nick , Tebbutt, Niall C. , Längle, Friedrich, Dhani, Neesha C. , Tehfe, Mustapha , Pfeiffer, Per , Osterlund, Pia J. , Tougeron, David , Caroli‐Bosc, François‐Xavier , Walter, Thomas , Bachet, Jean‐Baptiste , Block, Andreas, Venerito, Marino , Trojan, Jörg , Lerch, Markus M. , Schulz, Holger, Yau, Thomas , Juhasz, Balazs, Bodoky, Gyorgy , Gianni, Luca , Siena, Salvatore , Falcone, Alfredo , Berardi, Rossana , Costanzo, Francesco Di , Ardizzoni, Andrea , Maiello, Evaristo , Barroso, Eduardo , Sarmento, Cristina, Chee, Cheng Ean , López López, Rafael , Sáez, Berta Laquente, Chan, De‐Chuan , Evans, Jeffry, Corrie, Pippa G. , Cardin, Dana B. , Noonan, Anne M. , George, Thomas J. , Arena, Francis P. , McWilliams, Robert R. , Seth, Rahul, Ramirez, Robert A. , Reeves, James, El-Khoueiry, Anthony B. , Weaver, Robert, Dreicer, Robert , Borad, Mitesh J. , Huyck, Timothy K., Xiong, Henry Q., Oberstein, Paul E.
Journal of Clinical Oncology | December 15, 2022 | Volume: 41 | Issue: 11 | Pages: 2007-2019
PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430 ). METHODS We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m 2 ) + gemcitabine (1,000 mg/m 2 ) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety. RESULTS Two hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 ( nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P = .18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P = .02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P = .045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 ( nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P = .0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P = .0091). Eighty-six percent ( nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events. CONCLUSION The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.