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2. Randomized trial of bilateral gene therapy injection for m.11778G>A MT-ND4 Leber optic neuropathy

Author

Newman, Nancy J, Yu-Wai-Man, Patrick, Subramanian, Prem S, Moster, Mark L, Wang, An-Guor, Donahue, Sean P, Leroy, Bart P, Carelli, Valerio, Biousse, Valerie, Vignal-Clermont, Catherine, Sergott, Robert C, Sadun, Alfredo A, Rebolleda Fernández, Gema, Chwalisz, Bart K, Banik, Rudrani, Bazin, Fabienne, Roux, Michel, Cox, Eric D, Taiel, Magali, Sahel, José-Alain, Giulia, Amore, Shweta, Anand, Rudrani, Banik, Piero, Barboni, Valérie, Biousse, Hayley, Boston, Asma, Burale, Michele, Carbonelli, Valerio, Carelli, Celia, Chen, Hui-Chen, Cheng, Steve, Cho, Manuela, Contin, Pietro, D’Agati, DeBusk, Adam A, Julie, De Zaeytijd, Jannah, Dobbs, Lindreth, DuBois, Simona, Esposti, Alcides, Fernandes Filho, Elizabeth, Fortin, Sapna, Gangaputra, Deborah, Gibbs, François, Girmens Jean, Rabih, Hage, Haller, Julia A, Gad, Heilweil, George Baker, Hubbard III, Jeong-Min, Hwang, Laia, Jaumendreu Urquijo, Neringa, Jurkute, Rustum, Karanjia, Wahiba, Khemliche, La Chiara, Morgia, Maria, Massini, Marc, Mathias, Memon, Muhammad A, Susan, Mohamed, Muñoz Negrete, Francisco J, Ghazala, O’Keefe, Shriji, Patel, Paula, Pecen, Peragallo, Jason H, Lise, Plaine, Mary, Preston, Gema, Rebolleda Fernández, Martina, Romagnoli, José-Alain, Sahel, Melissa, SantaMaria, Chuanbin, Sun, Katy, Tai, Heather, Tollis, Irena, Tsui, Tucker, William R, Catherine, Vignal-Clermont, An-Guor, Wang, Saige, Wilkins, and Patrick, Yu-Wai-Man

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Clinical Research, Genetics, Neurosciences, Clinical Trials and Supportive Activities, Eye Disease and Disorders of Vision, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Eye, Humans, DNA, Mitochondrial, Genetic Therapy, Inflammation, Mutation, Optic Atrophy, Hereditary, Leber, LHON REFLECT Study Group, NADH dehydrogenase 4, leber hereditary optic neuropathy, lenadogene nolparvovec, mitochondrial DNA, recombinant adeno-associated virus vector 2, Medical and Health Sciences, Psychology and Cognitive Sciences, Neurology & Neurosurgery, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

Leber hereditary optic neuropathy (LHON) is an important example of mitochondrial blindness with the m.11778G>A mutation in the MT-ND4 gene being the most common disease-causing mtDNA variant worldwide. The REFLECT phase 3 pivotal study is a randomized, double-masked, placebo-controlled trial investigating the efficacy and safety of bilateral intravitreal injection of lenadogene nolparvovec in patients with a confirmed m.11778G>A mutation, using a recombinant adeno-associated virus vector 2, serotype 2 (rAAV2/2-ND4). The first-affected eye received gene therapy; the fellow (affected/not-yet-affected) eye was randomly injected with gene therapy or placebo. The primary end point was the difference in change from baseline of best-corrected visual acuity (BCVA) in second-affected/not-yet-affected eyes treated with lenadogene nolparvovec versus placebo at 1.5 years post-treatment, expressed in logarithm of the minimal angle of resolution (LogMAR). Forty-eight patients were treated bilaterally and 50 unilaterally. At 1.5 years, the change from baseline in BCVA was not statistically different between second-affected/not-yet-affected eyes receiving lenadogene nolparvovec and placebo (primary end point). A statistically significant improvement in BCVA was reported from baseline to 1.5 years in lenadogene nolparvovec-treated eyes: -0.23 LogMAR for the first-affected eyes of bilaterally treated patients (P < 0.01); and -0.15 LogMAR for second-affected/not-yet-affected eyes of bilaterally treated patients and the first-affected eyes of unilaterally treated patients (P < 0.05). The mean improvement in BCVA from nadir to 1.5 years was -0.38 (0.052) LogMAR and -0.33 (0.052) LogMAR in first-affected and second-affected/not-yet-affected eyes treated with lenadogene nolparvovec, respectively (bilateral treatment group). A mean improvement of -0.33 (0.051) LogMAR and -0.26 (0.051) LogMAR was observed in first-affected lenadogene nolparvovec-treated eyes and second-affected/not-yet-affected placebo-treated eyes, respectively (unilateral treatment group). The proportion of patients with one or both eyes on-chart at 1.5 years was 85.4% and 72.0% for bilaterally and unilaterally treated patients, respectively. The gene therapy was well tolerated, with no systemic issues. Intraocular inflammation, which was mostly mild and well controlled with topical corticosteroids, occurred in 70.7% of lenadogene nolparvovec-treated eyes versus 10.2% of placebo-treated eyes. Among eyes treated with lenadogene nolparvovec, there was no difference in the incidence of intraocular inflammation between bilaterally and unilaterally treated patients. Overall, the REFLECT trial demonstrated an improvement of BCVA in LHON eyes carrying the m.11778G>A mtDNA mutation treated with lenadogene nolparvovec or placebo to a degree not reported in natural history studies and supports an improved benefit/risk profile for bilateral injections of lenadogene nolparvovec relative to unilateral injections.

Published
2023

3. Indirect Comparison of Lenadogene Nolparvovec Gene Therapy Versus Natural History in Patients with Leber Hereditary Optic Neuropathy Carrying the m.11778G>A MT-ND4 Mutation.

Author

Carelli, Valerio, Newman, Nancy, Yu-Wai-Man, Patrick, Biousse, Valerie, Moster, Mark, Subramanian, Prem, Vignal-Clermont, Catherine, Wang, An-Guor, Donahue, Sean, Leroy, Bart, Sergott, Robert, Klopstock, Thomas, Sadun, Alfredo, Rebolleda Fernández, Gema, Chwalisz, Bart, Banik, Rudrani, Girmens, Jean, La Morgia, Chiara, DeBusk, Adam, Jurkute, Neringa, Priglinger, Claudia, Karanjia, Rustum, Josse, Constant, Salzmann, Julie, Montestruc, François, Roux, Michel, Taiel, Magali, and Sahel, José-Alain

Subjects
Gene therapy, LHON, Leber hereditary optic neuropathy, MT-ND4, Natural history, Visual acuity
Abstract

INTRODUCTION: Lenadogene nolparvovec is a promising novel gene therapy for patients with Leber hereditary optic neuropathy (LHON) carrying the m.11778G>A ND4 mutation (MT-ND4). A previous pooled analysis of phase 3 studies showed an improvement in visual acuity of patients injected with lenadogene nolparvovec compared to natural history. Here, we report updated results by incorporating data from the latest phase 3 trial REFLECT in the pool, increasing the number of treated patients from 76 to 174. METHODS: The visual acuity of 174 MT-ND4-carrying patients with LHON injected in one or both eyes with lenadogene nolparvovec from four pooled phase 3 studies (REVERSE, RESCUE and their long-term extension trial RESTORE; and REFLECT trial) was compared to the spontaneous evolution of an external control group of 208 matched patients from 11 natural history studies. RESULTS: Treated patients showed a clinically relevant and sustained improvement in their visual acuity when compared to natural history. Mean improvement versus natural history was - 0.30 logMAR (+ 15 ETDRS letters equivalent) at last observation (P

Published
2023

7. Eight-Year Outcomes of Bilateral Lateral Rectus Recessions versus Unilateral Recession-Resection in Childhood Basic-Type Intermittent Exotropia

Author

Miller, Aaron M., Olvera, Maria N., Alexander, Monsey L., Curtin, Kathleen Mary, Dillon, Angela C., Gray, Carole L., Jackson, Jorie L., Qadir, Ximena V., Ramos, Cynthia R., Paysse, Evelyn A., Coats, David K., Yen, Kimberly G., Romany, Gihan, Homann, Melynda J., Kong, Lingkun, Law, Christine, Churchill, Sarah, MacSween, Lesley E., Hoover, Darren L., Huston, Pamela A., Racan, Pamela M., Soros, Kari E., Sala, Nicholas A., Sala, Nicholas Anthony, Johnson, Catherine, Sala, Allyson, Zeto, V. Lori, Donahue, Sean P., Wilkins, Carsyn Saige, Biernacki, Ronald J., Campbell, Megan K., Fraine, Lisa A., Ruark, Scott T., Crouch, Eric, Crouch, Earl R., Jr., Ventura, Gaylord G., Fritz, Carolina Andrea, Anderson, Jill S., Areaux, Raymond G., Jr, Holleschau, Ann M., Harder, Jessica Ann, May, Laura M., Merrill, Kim S., Schweigert, Anna I., Petersen, David B., Pickens, Tori S., McMurtrey, J. Ryan, Morrell, Beth A., Repka, Michael X., Liu, Xiaonong, Christoff, Alex, Silbert, David I., Modjesky, Heather, Woodall, Hayley L., Summers, Allison I., Kuo, Annie F., Wilson, Lorri B., Rauch, Paula, Lee, Jessy, Casey, Grant A., Narain, Srianna, Woodruff, Kevin, Ticho, Benjamin H., Clausius, Deborah A., Allen, Megan, Quebbemann, Micaela N., Shah, Birva K., Bothun, Erick D., Holmes, Jonathan M., Mohney, Brian G., Wernimont, Suzanne M., Czaplewski, Lindsay L., Eastman, Stacy L., Huisman, Jordan Joseph, Klaehn, Lindsay D., Kramer, Andrea M., Kroening, Rose M., Priebe, Debbie M., Wohlers, Moriah A., Jensen, Allison A., Flanagan, Maureen A., Tolbert, Tiffany Talia, Traboulsi, Elias, Ghasia, Fatema F., Meador, Angela M., McOwen, Diana Christine, Enyedi, Laura B., Jones, Sarah K., Kashyap, Namita, Loud, Rachel N., Waters, Amy L., Marsh, Justin D., Bond, Lezlie L., Ariss, Michelle M., Dent, Rebecca J., Phillips, Paul H., Lowery, Robert Scott, Haley, Wendy Jean, Brown, Shaina, Colon, Beth, Cupit, Shawn L., Holtorf, Hannah L., Sanders, Hayley Elizabeth, Bowsher, James D., Cheeseman, Edward W., Weas, Nikki M., Bradham, Carol U., Rahmani, Bahram, Ranaivo, Hantamalala Ralay, Cruz, Karla G., De Leon, Erika A., Klauer, Anthony Jeffrey, Tzanetakos, Vivian, McCoy Vrablec, Laura, Orge, Faruk H., Richards, Leslie, Baird, Alicia Marie, Glaser, Stephen R., Yost, Kasey L., Flores, Odalis R., Herlihy, Erin P., Taira, Alyssa, Alexander, Jessica, Gladstone, Amy, Kiens, Bridget Ann, Tews, Lyndsey A., Whitehead, George F., Shea, Caroline J., Stillman, SueAnn Marie, Nye, Christina N., Bartiss, Michael John, McGaw, Tennille F., Davis, Patricia L., Hulett, Katie R., Twite, Jacqueline, Bradfield, Yasmin S., Adler, Angela M., Anderson, Kristin A., Kraker, Raymond T., Beck, Roy W., Austin, Darrell S., Boyle, Nicole M., Chandler, Danielle L., Connelly, Patricia L., Conner, Courtney L., Donahue, Quayle, Fimbel, Brooke P., Henderson, Robert J., Hoepner, James E., Kaplon, Joseph D., Melia, B. Michele, Ortiz, Gillaine, Robinson, Julianne L., Stutz, Kathleen M., Sutherland, Desirae R., Toro, David O., Woodard, Victoria C., Wu, Rui, Cotter, Susan A., Birch, Eileen E., Christiansen, Stephen P., Hatt, Sarah R., Leske, David A., Melia, Michele, O’Hara, Mary, Pang, Yi, Romanchuck, Kenneth, Tamkins, Susanna M., Wallace, David K., Wheeler, David T., Bhatt, Amit, Chen, Angela M., Cheung, Nathan L., Cobb, Patricia, Colon, Beth J., Crouch, Eric R., Dean, Trevano W., Erzurum, S. Ayse, Esposito, Christina A., Fang, Caroline C., Gray, Michael E., Gunton, Kammi B., Hopkins, Kristine B., Jastrzembski, Benjamin G., Jenewein, Erin C., Jordan, Catherine O., Kraus, Courtney, Kurup, Sudhi P., Lazar, Elizabeth L., Li, Zhuokai, Lorenzana, Ingryd, McDowell, Paula S., Morrison, Ann M., Morrison, David G., Nylin, Elyse, Parker, Sue M., Patel, Reena, Plaumann, Maureen D., Pollack, Karen, Raghuram, Aparna, Retnasothie, Dashaini V., Roberts, Tawna L., Scheiman, Mitchell M., Shah, Veeral S., Superstein, Rosanne, Titelbaum, Jenna R., Vricella, Marilyn, Yamada, Tomohiko, Astle, William F., Christian, Melanie L., Everett, Donald F., Freedman, Sharon F., Good, William V., Lambert, Scott R., Lee, Katherine A., London, Richard, Manh, Vivian M., Manny, Ruth E., Pineles, Stacy L., Rogers, David L., Schweinler, Bonita R., Silver, Jayne L., Suh, Donny W., Verderber, Lisa C., Weise, Katherine K., Diener-West, Marie, Baker, John D., Davis, Barry, Higgins, Rosemary D., Poff, Stephen W., Saunders, Richard A., and Tychsen, Lawrence

Published
2024
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8. Safety of Lenadogene Nolparvovec Gene Therapy Over 5 Years in 189 Patients With Leber Hereditary Optic Neuropathy

Author

VIGNAL-CLERMONT, CATHERINE, YU-WAI-MAN, PATRICK, NEWMAN, NANCY J., CARELLI, VALERIO, MOSTER, MARK L., BIOUSSE, VALERIE, SUBRAMANIAN, PREM S., WANG, AN-GUOR, DONAHUE, SEAN P., LEROY, BART P., SADUN, ALFREDO A., KLOPSTOCK, THOMAS, SERGOTT, ROBERT C., REBOLLEDA FERNANDEZ, GEMA, CHWALISZ, BART K., BANIK, RUDRANI, TAIEL, MAGALI, ROUX, MICHEL, and SAHEL, JOSÉ-ALAIN

Published
2023
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9. Prepare Now For The Universal Proxy Card

Author

Donahue, Sean M. and Newell, John O.

Subjects
Judicial opinions, Proxy, Business, general, Business
Abstract

The U. S. Securities and Exchange Commission has shaken up proxy contest rules by changing a simple piece of paper. The 'universal proxy card' will level the playing field between [...]

Published
2022

10. Doses of medial rectus muscle recessions for divergence insufficiency-type esotropia

Author

Miller, Aaron M., primary, Holmes, Jonathan M., additional, Wu, Rui, additional, Kraker, Raymond T., additional, Crouch, Eric R., additional, Lee, Katherine A., additional, Del Monte, Monte A., additional, Marsh, Justin D., additional, Kraus, Courtney L., additional, Wallace, David K., additional, Colburn, Jeffrey D., additional, Kemp, Pavlina S., additional, Cotter, Susan A., additional, Beck, Roy W., additional, Alvarez, Gillaine, additional, Austin, Darrell S., additional, Boyle, Nicole M., additional, Chandler, Danielle L., additional, Connelly, Patricia L., additional, Conner, Courtney L., additional, Dean, Trevano W., additional, Donahue, Quayleen, additional, Fimbel, Brooke P., additional, Henderson, Robert J., additional, Hercinovic, Amra, additional, Hoepner, James E., additional, Kaplon, Joseph D., additional, Li, Zhuokai, additional, Melia, B. Michele, additional, Robinson, Julianne L., additional, Shah, Jennifer A., additional, Toro, David O., additional, Jenewein, Erin C., additional, Felius, Joost, additional, Collins, Megan E., additional, Leske, David A., additional, Astle, William F., additional, Birch, Eileen E., additional, Chen, Angela M., additional, Christian, Melanie L., additional, Christiansen, Stephen P., additional, Crouch, Earl R., additional, Donahue, Sean P., additional, Enyedi, Laura B., additional, Erzurum, S. Ayse, additional, Everett, Donald F., additional, Freedman, Sharon F., additional, Good, William V., additional, Lambert, Scott R., additional, London, Richard, additional, Manh, Vivian M., additional, Manny, Ruth E., additional, Morrison, David G., additional, Pineles, Stacy L., additional, Ranaivo, Hantamalala Ralay, additional, Repka, Michael X., additional, Ruark, Scott T., additional, Schweinler, Bonita R., additional, Silver, Jayne L., additional, Summers, Allison I., additional, Verderber, Lisa C., additional, and Weise, Katherine K., additional

Published
2024
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11. Study design and baseline characteristics for the reflect gene therapy trial ofm.11778g>A/ND4-LHON

Author

Nancy J Newman, Valérie Biousse, José-Alain Sahel, Patrick Yu-Wai-Man, Sean Donahue, Gema Rebolleda, Prem S Subramanian, Bart P Leroy, Alfredo A Sadun, Robert C Sergott, Catherine Vignal-Clermont, Bart K Chwalisz, Mark Moster, An-Guor Wang, Valerio Carelli, Rudrani Banik, Fabienne Bazin, Eric Cox, Michel Roux, Magali Taiel, Amore Giulia, Anand Shweta, Banik Rudrani, Barboni Piero, Biousse Valérie, Boston Hayley, Burale Asma, Carbonelli Michele, Carelli Valerio, Chen Celia, Cheng Hui-Chen, Cho Steve, K Chwalisz Bart, Contin Manuela, D’Agati Pietro, A DeBusk Adam, De Zaeytijd Julie, Dobbs Jannah, P Donahue Sean, DuBois Lindreth, Esposti Simona, Fernandes Filho Alcides, Fortin Elizabeth, Gangaputra Sapna, Gibbs Deborah, Girmens Jean François, Hage Rabih, A Haller Julia, Heilweil Gad, Hubbard III GeorgeBaker, Hwang Jeong-Min, Jaumendreu Urquijo Laia, Jurkute Neringa, Karanjia Rustum, Khemliche Wahiba, La Morgia Chiara, P Leroy Bart, Massini Maria, Mathias Marc, A Memon Muhammad, Mohamed Susan, L Moster Mark, J Muñoz NegreteFrancisco, J Newman Nancy, O’Keefe Ghazala, Patel Shriji, Pecen Paula, H Peragallo Jason, Plaine Lise, Preston Mary, Rebolleda Fernández Gema, Romagnoli Martina, A Sadun Alfredo, A Sahel José, SantaMaria Melissa, C Sergott Robert, S Subramanian Prem, Sun Chuanbin, Tai Katy, Tollis Heather, Tsui Irena, R Tucker William, Vignal-Clermont Catherine, Wang An-Guor, Wilkins Saige, and Yu-Wai-Man Patrick

Subjects
Ophthalmology, RE1-994
Abstract

Objective REFLECT is the first randomised, double-masked, placebo-controlled multicentre phase 3 clinical trial that evaluated the efficacy and safety of bilateral intravitreal (IVT) injection of lenadogene nolparvovec in subjects with Leber hereditary optic neuropathy carrying the m.11778G>A mutation.Methods and analysis A total of 98 subjects were enrolled with vision loss of ≤12 months. The subjects were randomised to one of two treatment arms with all subjects receiving an intravitreal (IVT) injection of lenadogene nolparvovec in their first affected eye and the second-affected eye randomised to receive IVT of either lenadogene nolparvovec or placebo.Results The majority of subjects were male with a mean duration of vision loss of 8.3 months. All but one subject experienced bilateral loss of vision at the time of injection. The mean best-corrected visual acuity of first-affected eyes was worse compared with second/not-yet-affected eyes. Analysis of retinal anatomical parameters showed increased thinning in the first-affected eyes when compared with the second/not-yet-affected eyes with both treatment arms showing significant changes compared with unaffected individuals.Conclusion The REFLECT trial is the third and the largest phase 3 clinical study evaluating lenadogene nolparvovec in m.11778G>A Leber hereditary optic neuropathy (LHON) subjects. The observed demographics in REFLECT are consistent with previous reports in LHON subjects in the acute and dynamic phases of LHON disease. Combined with the visual function and anatomical parameters obtained in the previous RESCUE and REVERSE trials, REFLECT has provided a uniformly collected data set that should help direct future LHON clinical trials.

Published
2022
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14. The Dark Knowledge Problem: Why Public Justifications are Not Arguments.

Author

Donahue, Sean

Subjects
*METHODOLOGY, *CITIZENSHIP, *CONSTITUTIONAL law, *POLITICAL science, *VIRTUES
Abstract

According to the Public Justification Principle, legitimate laws must be justifiable to all reasonable citizens. Proponents of this principle assume that its satisfaction requires speakers to offer justifications that are representable as arguments that feature premises which reasonable listeners would accept. I develop the concept of dark knowledge to show that this assumption is false. Laws are often justified on the basis of premises that many reasonable listeners know, even though they would reject these premises on the basis of the further considerations that speakers implicitly rely on for their support. Accommodating the fact of dark knowledge requires us to consider the civic virtue of speakers to be more important for public justification than the acceptability of their arguments to reasonable citizens. I sketch an alternative conception of public justification that incorporates these results and argue that it provides a rationale for ignoring the otherwise sound contributions of some participants in political deliberation. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Accuracy and Reproducibility of Virtual Reality Perimetry in Children.

Author

Pruett, Jaron K., Linton, Edward F., Donahue, Sean P., and Groth, Sylvia L.

Subjects
VIRTUAL reality, PERIMETRY, VIRTUAL reality therapy, INTRACLASS correlation, HEAD-mounted displays, VISUAL fields
Abstract

Purpose: To determine normal threshold values for the 24-2 program of the VisuALL-K (Olleyes, Inc), a portable static automated virtual reality perimeter that uses a video game–based testing modality on an updated version of the algorithm and to repeat the test to assess retest variability. Methods: This prospective cohort study included 19 participants (aged 8 to 17 years) with healthy afferent systems. Participants performed two 24-2 automated perimetry tests on the virtual reality perimeter device. Results: Mean age was 12.7 ± 2.5 years; 53% were boys and 47% were girls. Mean test location threshold was 30.5 ± 4.0 dB for test 1 and 31.3 ± 2.8 dB for test 2. Sensitivity decreased with eccentricity as expected (−0.17 dB per degree). Bland-Altman analysis showed a repeatability coefficient of ±5.1 dB for mean deviation, meaning that 95% of retest values were within ±5 dB of the threshold value for the first test. Higher thresholds for the first test regressed toward the mean values in the second test, indicating a learning effect. Intraclass correlation coefficient for mean deviation between test 1 and test 2 was 0.70 (0.55 to 0.80, P <.0001). Mean time to completion for the virtual reality perimeter was 5.1 ± 1.5 min/eye. Conclusions: The VisuALL-K virtual reality perimeter provided an assessment of the visual field in normal children aged 8 to 17 years. A shallow hill of vision was demonstrated. A notable learning effect was demonstrated, with repeatability difference wider than other published head-mounted display perimeters. [J Pediatr Ophthalmol Strabismus. 2024:61(4):262–266.] [ABSTRACT FROM AUTHOR]

Published
2024
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19. Prevalence of cerebrotendinous xanthomatosis among patients diagnosed with early-onset idiopathic bilateral cataracts: final analysis

Author

Freedman, Sharon F., primary, Del Monte, Monte A., additional, Diva, Ulysses, additional, Donahue, Sean P., additional, Drack, Arlene V., additional, Dutta, Rana, additional, Fung, Simon S.M., additional, Imperiale, Michael, additional, Jordan, Catherine O., additional, Lenhart, Phoebe D., additional, Lim, Maria E., additional, McCourt, Emily A., additional, Nihalani, Bharti R., additional, Sabahi, Tarlan, additional, Stahl, Erin D., additional, Miraldi Utz, Virginia A., additional, Wilson, M. Edward, additional, Yen, Kimberly G., additional, and VanderVeen, Deborah K., additional

Published
2023
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20. Ocular complications following treatment in the Postnatal Growth and Retinopathy of Prematurity (G-ROP) Study

Author

Binenbaum, Gil, Tomlinson, Lauren A., Duros, Trang B., Ying, Gui-shuang, Maguire, Maureen G., Brightwell-Arnold, Mary, Shaffer, James, Blanco, Maria, Brown, Trina, Helker, Christopher P., Barry, Gerard P., Fisher, Marilyn, Battaglia, Maria V., Drach, Alex M., Donohue, Pamela, Repka, Michael X., Doherty, Megan, Dow, Dorothy, Shepard, Jennifer A., Reynolds, James D., Connelly, Erin, Cheeseman, Edward, Bradham, Carol, McAlpine, Allison, Sunthankar, Sudeep, Shirer, Kinsey, Abbasian, Javaneh, Lim, Janet, Yang, Michael, Alfano, Elizabeth L., Cobb, Patricia, Rogers, David, Fellows, Rae R., Loh, Kaitlyn, McGregor, Madeline A., Mustafa, Thabit, Reem, Rachel E., Russell, Tess, Stattler, Rebecca, Oravec, Sara, Young, David, Siu, Andrea, Kanemori, Michele, Wang, Jingyun, Haider, Kathryn, Hynes, Elizabeth, Bell, Edward F., Dumitrescu, Alina V., Klein, Jonathan M., Ajjarapu, Avanthi S., Cress, Gretchen A., Funk, Bethany M., Johnson, Claire L., Platt, Angela C., Khazaeni, Leila, Dunbar, Jennifer, Hawkins, Kelley, Lee, Sharon, Sung, Lily, Bhola, Rahul, Bottorff, Michelle, Dimova, Neviana, Keith, Rachel, Thomas, Laura, Anderson, Jill, Gross, Jordan, Holleschau, Ann Marie, Kramer, Andrea, Morrison, David, Donahue, Sean, Fukuda, Neva, Owings, Sandy, Ruark, Scott, Siatkowski, R. Michael, Bhatti, Faizah, Bergman, Vanessa, Corff, Karen, Harkey, Kari, Manfredo, Amy, Talsania, Shrenik, Whisenhunt, Terri, Kirpalani, Haresh, Quinn, Graham E., Dawson, Lindsay, Chen, Wendy S., Jackson, Deidrya, Davitt, Bradley, Govreau, Dawn, Breuer, Linda, Noonan, September, Hoffman, Robert, Beachy, Joanna, Harrison, Deborah, Bernhisel, Ashlie, Carlstrom, Bonnie, Farnsworth, Katie Jo, de Alba Campomanes, Alejandra G., Kemmer, Jacquelyn, Neiman, Alexandra, Sitati-Ng’Anda, Sarah, Baran, Francine, Tarczy-Hornoch, Kristina, Eaton, Lauren, Najm-Tehrani, Nasrin, Isaac, Maram, Knighton, Robin, Khitri, Monica Ralli, Del Signore, Madeline, Dembofsky, Cynthia, Meyer, Andrew, Flaherty, Karen, Harris, Tracey, Heeneke, Jamie, Fecarotta, Christopher M., Hendricks, Dorothy, Fisher, Alicia Olivant, Paullin, Mark, Zupancic, John, and Ying, Gui-Shuang

Published
2018
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21. Single grading vs double grading with adjudication in the telemedicine approaches to evaluating acute-phase retinopathy of prematurity (e-ROP) study

Author

Quinn, Graham E., Wade, Kelly, Baumritter, Agnieshka, Duros, Trang B., Erbring, Lisa, Repka, Michael X., Shepard, Jennifer A., Emmert, David, Herring, C. Mark, VanderVeen, Deborah, Johnston, Suzanne, Wu, Carolyn, Mantagos, Jason, Ledoux, Danielle, Winter, Tamar, Weng, Frank, Mansfield, Theresa, Bremer, Don L., McGregor, Mary Lou, Jordan, Catherine Olson, Rogers, David L., Fellows, Rae R., Brandt, Suzanne, Mann, Brenda, Wallace, David, Freedman, Sharon, Jones, Sarah K., Tran-Viet, Du, Young, Rhonda “Michelle”, Barr, Charles C., Bhola, Rahul, Douglas, Craig, Fishman, Peggy, Bottorff, Michelle, Hubbuch, Brandi, Keith, Rachel, Bothun, Erick D., DeBecker, Inge, Anderson, Jill, Holleschau, Ann Marie, Miller, Nichole E., Nyquist, Darla N., Siatkowski, R. Michael, Trigler, Lucas, Escobedo, Marilyn, Corff, Karen, Huynh, Michelle, Satnes, Kelli, Mills, Monte D., Anninger, Will, Binenbaum, Gil, Quinn, Graham, Karp, Karen A., Pearson, Denise, Gong, Alice, Stokes, John, Harper, Clio Armitage, Weaver, Laurie, McHenry, Carmen, Conner, Kathryn, Heemer, Rosalind, Cokley, Elnora, Hoffman, Robert, Dries, David, Farnsworth, Katie Jo, Harrison, Deborah, Carlstrom, Bonnie, Frye, Cyrie Ann, Morrison, David, Donahue, Sean, Benegas, Nancy, Owings, Sandy, Phillips, Sandra, Ruark, Scott, Ells, Anna, Mitchell, Patrick, Ingram, April, Sorbie, Rosie, Ying, Gui-Shuang, Maguire, Maureen, Brightwell-Arnold, Mary, Pistilli, Max, McWilliams, Kathleen, Harris, Sandra, Whearry, Claressa, Daniel, Ebenezer, Martin, E. Revell, Parker Ostroff, Candace R., Sepielli, Krista, Smith, Eli, Capone, Antonio, Hubbard, G. Baker, Lloyd, Peter, Davis, Kerry, Gibson, G. Carl, Hansen, Regina, Kemper, Alex R., Prosser, Lisa, Musch, David C., Christiansen, Stephen P., Hess, Ditte J., Kymes, Steven M., Sadda, SriniVas R., Spaulding, Ryan, Schron, Eleanor B., and Pan, Wei

Published
2018
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28. Eight-Year Outcomes of Bilateral Lateral Rectus Recessions versus Unilateral Recession-Resection in Childhood Basic-Type Intermittent Exotropia.

Author

Donahue, Sean P., Chandler, Danielle L., Wu, Rui, Marsh, Justin D., Law, Christine, Areaux, Raymond G., Ghasia, Fatema F., Li, Zhuokai, Kraker, Raymond T., Cotter, Susan A., and Holmes, Jonathan M.

Subjects
*EXOTROPIA, *RANDOMIZED controlled trials
Abstract

To report 8-year outcomes from a randomized controlled trial (RCT) comparing bilateral lateral rectus muscle recession (BLRc) with unilateral recession-resection (R&R) for childhood intermittent exotropia (IXT). Eight-year follow-up of RCT cohort. Of 197 randomized participants, 123 agreed to continue follow-up after the 3-year outcome visit (baseline age, 3–< 11 years; basic-type IXT, 15–40 prism diopters [Δ] by prism and alternate cover test [PACT]; baseline stereoacuity, ≤ 400 arcsec; no prior surgery). After the RCT primary outcome at 3 years, annual follow-up from 4 through 8 years with treatment at investigator discretion. Suboptimal surgical outcome by 8 years after randomization, defined as any of the following at any visit: exotropia of 10 Δ or more by simultaneous prism cover test (SPCT) at distance or near, constant esotropia (ET) of 6 Δ or more by SPCT at distance or near, loss of near stereoacuity by 0.6 log arcsec or more from baseline, or reoperation. Secondary outcomes included (1) reoperation by 8 years and (2) complete or near-complete resolution at 8 years, defined as exodeviation of less than 10 Δ by SPCT and PACT at distance and near and 10 Δ or more reduction from baseline by PACT at distance and near, ET of less than 6 Δ at distance and near, no decrease in stereoacuity by 0.6 log arcsec or more from baseline, and no reoperation or nonsurgical treatment for IXT. The Kaplan-Meier cumulative probability of suboptimal surgical outcome through 8 years was 68% (55 events among 101 at risk) for BLRc and 53% (42 events among 96 at risk) for R&R (difference, 15%; 95% confidence interval [CI], –2% to 32%; P = 0.08). Complete or near-complete resolution at 8 years occurred in 15% (7/46) for BLRc and 37% (16/43) for R&R (difference, –22%; 95% CI, –44% to –0.1%; P = 0.049). The cumulative probability of reoperation was 30% for BLRc and 11% for R&R (difference, 19%; 95% CI, 2%–36%; P = 0.049). Despite no significant difference for the primary outcome, the 95% CI did not exclude a moderate benefit of R&R, which together with secondary outcomes suggests that unilateral R&R followed by usual care may yield better long-term outcomes than BLRc followed by usual care for basic-type childhood IXT using these surgical doses. 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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30. Indirect Comparison of Lenadogene Nolparvovec Gene Therapy versus Natural History in m.11778G>A MT-ND4 Leber Hereditary Optic Neuropathy Patients (S12.005)

Author

Newman, Nancy, primary, Carelli, Valerio, additional, Yu-Wai-Man, Patrick, additional, Biousse, Valerie, additional, Moster, Mark, additional, Subramanian, Prem, additional, Vignal-Clermont, Catherine, additional, Wang, An-Guor, additional, Donahue, Sean, additional, Leroy, Bart, additional, Sergott, Robert, additional, Klopstock, Thomas, additional, Sadun, Alfredo, additional, Rebolleda, Gema, additional, Chwalisz, Bart, additional, Banik, Rudrani, additional, Taiel, Magali, additional, and Sahel, Jose-Alain, additional

Published
2023
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32. Safety of Retinopathy of Prematurity Examination and Imaging in Premature Infants

Author

Quinn, Graham E., Wade, Kelly, Baumritter, Agnieshka, Duros, Trang B., Erbring, Lisa, Repka, Michael X., Shepard, Jennifer A., Emmert, David, Herring, C. Mark, VanderVeen, Deborah, Johnston, Suzanne, Wu, Carolyn, Mantagos, Jason, Ledoux, Danielle, Winter, Tamar, Weng, Frank, Mansfield, Theresa, Bremer, Don L., McGregor, Mary Lou, Jordan, Catherine Olson, Rogers, David L., Fellows, Rae R., Brandt, Suzanne, Mann, Brenda, Wallace, David, Freedman, Sharon, Jones, Sarah K., Tran-Viet, Du, Young, Rhonda “Michelle”, Barr, Charles C., Bhola, Rahul, Douglas, Craig, Fishman, Peggy, Bottorff, Michelle, Hubbuch, Brandi, Keith, Rachel, Bothun, Erick D., DeBecker, Inge, Anderson, Jill, Holleschau, Ann Marie, Miller, Nichole E., Nyquist, Darla N., Siatkowski, R. Michael, Trigler, Lucas, Escobedo, Marilyn, Corff, Karen, Huynh, Michelle, Satnes, Kelli, Mills, Monte D., Anninger, Will, Binenbaum, Gil, Quinn, Graham, Karp, Karen A., Pearson, Denise, Gong, Alice, Stokes, John, Harper, Clio Armitage, Weaver, Laurie, McHenry, Carmen, Conner, Kathryn, Heemer, Rosalind, Cokley, Elnora, Hoffman, Robert, Dries, David, Farnsworth, Katie Jo, Harrison, Deborah, Carlstrom, Bonnie, Fry, Cyrie Ann, Morrison, David, Donahue, Sean, Benegas, Nancy, Owings, Sandy, Phillips, Sandra, Ruark, Scott, Ells, Anna, Mitchell, Patrick, Ingram, April, Sorbie, Rosie, Ying, Gui-shuang, Maguire, Maureen, Brightwell-Arnold, Mary, Pistilli, Max, McWilliams, Kathleen, Harkins, Sandra, Daniel, Ebenezer, Martin, E. Revell, Parker Ostroff, Candace R., Sepielli, Krista, Smith, Eli, Whearry, Claressa, Capone, Antonio, Hubbard, G. Baker, Hildebrand, Peter Lloyd, Davis, Kerry, Gibson, G. Carl, Hansen, Regina, Kemper, Alex R., Prosser, Lisa, Musch, David C., Christiansen, Stephen P., Hess, Ditte J., Kymes, Steven M., Sadda, SriniVas R., Spaulding, Ryan, Wade, Kelly C., Pistilli, Maxwell, Karp, Karen, and Ying, Gui-Shuang

Published
2015
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35. Safety of lenadogene nolparvovec gene therapy over 5 years in 189 patients with Leber hereditary optic neuropathy

Author

Vignal-ClermoḤ, Catherine, Yu-Wai-Man, Patrick, Sadun, Alfredo A, Klopstock, Thomas, Sergott, Robert C, Fernández, Gema Rebolleda, Chwalisz, Bart K, Banik, Rudrani, Taiel, Magali, Roux, Michel, Sahel, José-Alain, Group, LHON Study, Newman, Nancy J, Carelli, Valerio, Moster, Mark L, Biousse, Valerie, Subramanian, Prem S, Wang, An-Guor, Donahue, Sean P, Leroy, Bart P, Vignal-ClermoḤ, Catherine, Yu-Wai-Man, Patrick, Newman, Nancy J, Carelli, Valerio, Moster, Mark L, Biousse, Valerie, Subramanian, Prem S, Wang, An-Guor, Donahue, Sean P, Leroy, Bart P, Sadun, Alfredo A, Klopstock, Thoma, Sergott, Robert C, Fernández, Gema Rebolleda, Chwalisz, Bart K, Banik, Rudrani, Taiel, Magali, Roux, Michel, and Sahel, José-Alain

Subjects
genetics [Parvovirinae], safety, Ophthalmology, genetics [Optic Atrophy, Hereditary, Leber], etiology [Inflammation], Genetic Vectors, Humans, intravitreal gene therapy, drug therapy [Optic Atrophy, Hereditary, Leber], ddc:610, Genetic Therapy, Leber hereditary optic neuropathy
Abstract

Purpose: Evaluate the safety profile of lenadogene nolparvovec (Lumevoq®) in patients with Leber hereditary optic neuropathy. Design: Pooled analysis of safety data from 5 clinical studies. Methods: A total of 189 patients received single unilateral or bilateral intravitreal injections of a recombinant adeno-associated virus 2 (rAAV2/2) vector encoding the human wild-type ND4 gene. Adverse events (AEs) were collected throughout the studies, up to 5 years. Intraocular inflammation and increased intraocular pressure (IOP) were ocular AEs of special interest. Other assessments included ocular examinations, vector bio-dissemination and systemic immune responses against rAAV2/2. Results: Almost all patients (95.2%) received 9 × 1010 viral genomes and 87.8% had at least 2 years of follow-up. Most patients (75.1%) experienced at least one systemic AE, but systemic treatment-related AEs occurred in 3 patients, none was serious. Intraocular inflammation was reported in 75.6% of lenadogene nolparvovec-treated eyes. Almost all intraocular inflammations occurred in the anterior chamber (58.8%) or in the vitreous (40.3%) and was of mild (90.3%) or moderate (8.8%) intensity; most resolved with topical corticosteroids alone. All IOP increases were mild to moderate in intensity. No AE led to study discontinuation. Bio-dissemination of lenadogene nolparvovec and systemic immune response were limited. The safety profile was comparable for patients treated bilaterally and unilaterally. Conclusions: Lenadogene nolparvovec has a good overall safety profile with excellent systemic tolerability, consistent with limited bio-dissemination. The product is well tolerated, with mostly mild ocular side effects responsive to conventional ophthalmologic treatments.

Published
2022

37. The phase 3 REFLECT trial: Efficacy and safety of bilateral gene therapy for Leber hereditary optic neuropathy (LHON)

Author

Yu‐Wai‐Man, Patrick, primary, Newman, Nancy, additional, Subramanian, Prem, additional, Moster, Mark, additional, Wang, An‐Guor, additional, Donahue, Sean, additional, Leroy, Bart, additional, Carelli, Valerio, additional, Biousse, Valérie, additional, Vignal‐Clermont, Catherine, additional, Sadun, Alfredo, additional, Sergott, Robert, additional, Fernández, Gema Rebolleda, additional, Chwalisz, Bart, additional, Banik, Rudrani, additional, Cox, Eric, additional, Roux, Michel, additional, Taiel, Magali, additional, and Sahel, José‐Alain, additional

Published
2022
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39. Study design and baseline characteristics for the reflect gene therapy trial ofm.11778g>A/ND4-LHON

Author

Subramanian, Prem S, primary, Newman, Nancy J, additional, Moster, Mark, additional, Wang, An-Guor, additional, Yu-Wai-Man, Patrick, additional, Donahue, Sean, additional, Leroy, Bart P, additional, Carelli, Valerio, additional, Biousse, Valerie, additional, Vignal-Clermont, Catherine, additional, Sergott, Robert C, additional, Sadun, Alfredo A, additional, Rebolleda, Gema, additional, Chwalisz, Bart K, additional, Banik, Rudrani, additional, Bazin, Fabienne, additional, Cox, Eric, additional, Roux, Michel, additional, Taiel, Magali, additional, and Sahel, Jose-Alain, additional

Published
2022
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40. Randomized trial of bilateral gene therapy injection for m.11778G>A MT-ND4 Leber optic neuropathy

Author

Newman, Nancy J., Yu-Wai-Man, Patrick, Subramanian, Prem S., Moster, Mark L., Wang, An-Guor, Donahue, Sean P., Leroy, Bart, Carelli, Valerio, Biousse, Valerie, Vignal-Clermont, Catherine, Sergott, Robert C., Sadun, Alfredo A., Fernandez, Gema Rebolleda, Chwalisz, Bart K., Banik, Rudrani, Bazin, Fabienne, Roux, Michel, Cox, Eric D., Taiel, Magali, Sahel, Jose-Alain, and Study Grp, LHON REFLECT

Subjects
EXPRESSION, MUTATIONS, Biology and Life Sciences, DNA, COHERENCE TOMOGRAPHY, FIBER LAYER EVALUATION, mitochondrial, recombinant adeno-associated virus vector 2, COMPLEX-I, VISUAL FUNCTION, leber hereditary optic neuropathy, GANGLION-CELL, NERVE-FIBER, BIODISTRIBUTION, END-POINTS, Medicine and Health Sciences, NADH dehydrogenase 4, Neurology (clinical), lenadogene nolparvovec
Abstract

Leber hereditary optic neuropathy (LHON) is an important example of mitochondrial blindness with the m.11778G>A mutation in the MT-ND4 gene being the most common disease-causing mtDNA variant worldwide. The REFLECT phase 3 pivotal study is a randomized, double-masked, placebo-controlled trial investigating the efficacy and safety of bilateral intravitreal injection of lenadogene nolparvovec in patients with a confirmed m.11778G>A mutation, using a recombinant adeno-associated virus vector 2, serotype 2 (rAAV2/2-ND4). The first-affected eye received gene therapy; the fellow (affected/not-yet-affected) eye was randomly injected with gene therapy or placebo. The primary end point was the difference in change from baseline of best-corrected visual acuity (BCVA) in second-affected/not-yet-affected eyes treated with lenadogene nolparvovec versus placebo at 1.5 years post-treatment, expressed in logarithm of the minimal angle of resolution (LogMAR). Forty-eight patients were treated bilaterally and 50 unilaterally. At 1.5 years, the change from baseline in BCVA was not statistically different between second-affected/not-yet-affected eyes receiving lenadogene nolparvovec and placebo (primary end point). A statistically significant improvement in BCVA was reported from baseline to 1.5 years in lenadogene nolparvovec-treated eyes: -0.23 LogMAR for the first-affected eyes of bilaterally treated patients (P < 0.01); and -0.15 LogMAR for second-affected/not-yet-affected eyes of bilaterally treated patients and the first-affected eyes of unilaterally treated patients (P < 0.05). The mean improvement in BCVA from nadir to 1.5 years was -0.38 (0.052) LogMAR and -0.33 (0.052) LogMAR in first-affected and second-affected/not-yet-affected eyes treated with lenadogene nolparvovec, respectively (bilateral treatment group). A mean improvement of -0.33 (0.051) LogMAR and -0.26 (0.051) LogMAR was observed in first-affected lenadogene nolparvovec-treated eyes and second-affected/not-yet-affected placebo-treated eyes, respectively (unilateral treatment group). The proportion of patients with one or both eyes on-chart at 1.5 years was 85.4% and 72.0% for bilaterally and unilaterally treated patients, respectively. The gene therapy was well tolerated, with no systemic issues. Intraocular inflammation, which was mostly mild and well controlled with topical corticosteroids, occurred in 70.7% of lenadogene nolparvovec-treated eyes versus 10.2% of placebo-treated eyes. Among eyes treated with lenadogene nolparvovec, there was no difference in the incidence of intraocular inflammation between bilaterally and unilaterally treated patients. Overall, the REFLECT trial demonstrated an improvement of BCVA in LHON eyes carrying the m.11778G>A mtDNA mutation treated with lenadogene nolparvovec or placebo to a degree not reported in natural history studies and supports an improved benefit/risk profile for bilateral injections of lenadogene nolparvovec relative to unilateral injections. Newman et al. report that bilateral injection of lenadogene nolparvovec improves vision in patients carrying the m.11778G>A MT-ND4 mutation causing Leber hereditary optic neuropathy, with a larger treatment effect in patients who received bilateral treatment and an excellent safety profile.

Published
2023

41. Lessons From The First Universal Proxy Contest

Author

Donahue, Sean M.

Subjects
Apartment Investment and Management Co. (Denver, Colorado) -- Officials and employees, Shareholder activism -- Management -- Forecasts and trends, Boards of directors -- Management, Voting rights (Stockholders) -- Management, Real estate investment trusts -- Officials and employees, Company business management, Market trend/market analysis, Business, international
Abstract

On December 16, 2022, shareholders of Apartment Investment and Management Company (the 'Company' or 'Aimco') cast their vote in the first proxy contest under the SEC's new universal proxy rules. [...]

Published
2022

42. ISS And Glass Lewis Issue 2023 Policy Updates

Author

Donahue, Sean M.

Subjects
Institutional Shareholder Services -- Laws, regulations and rules -- Environmental aspects -- Social aspects, Financial services industry -- Laws, regulations and rules -- Environmental aspects -- Social aspects, Government regulation, Financial services industry, Business, international
Abstract

Proxy advisory firms Institutional Shareholder Services (ISS) and Glass Lewis (GL) have issued their policy updates for the upcoming 2023 proxy season. In general, ISS's updates build incrementally on positions [...]

Published
2022

43. SEC Announces Record-Breaking Penalties And A 9% Increase In Total Number Of Enforcement Actions In FY 2022

Author

Donahue, Sean M.

Subjects
United States. Securities and Exchange Commission -- Powers and duties, Fines (Penalties) -- Laws, regulations and rules -- Statistics, Data mining -- Usage, Securities industry -- Laws, regulations and rules, Government regulation, Securities industry, Data warehousing/data mining, Business, international
Abstract

On November 15, 2022, the SEC announced its enforcement results for fiscal year 2022, which ended on September 30, reporting the following key metrics and highlights: 9% increase in number [...]

Published
2022

44. SEC Adopts Final Rules Requiring Disclosure And Recovery Of Erroneously Awarded Incentive-Based Compensation

Author

Donahue, Sean M.

Subjects
Financial disclosure -- Laws, regulations and rules, Executives -- Compensation and benefits, Securities industry -- Human resource management, Government regulation, Securities industry, Company personnel management, Business, international
Abstract

On October 26, 2022, the U.S. Securities and Exchange Commission ('SEC') adopted regulations (the 'final rules') implementing Section 10D of the Securities Exchange Act of 1934 ('Exchange Act'), which was [...]

Published
2022

49. The Pediatric Optic Neuritis Prospective Outcomes Study

Author

Pineles, Stacy L., primary, Henderson, Robert J., additional, Repka, Michael X., additional, Heidary, Gena, additional, Liu, Grant T., additional, Waldman, Amy T., additional, Borchert, Mark S., additional, Khanna, Sangeeta, additional, Graves, Jennifer S., additional, Collinge, Janine E., additional, Conley, Julie A., additional, Davis, Patricia L., additional, Kraker, Raymond T., additional, Cotter, Susan A., additional, Holmes, Jonathan M., additional, Chang, Melinda Y., additional, Contractor, Dilshad, additional, Zolfaghari, Emily J., additional, Vyas, Aarti, additional, Yuen, Tiffany, additional, Shah, Veeral S., additional, Paysse, Evelyn A., additional, Romany, Gihan, additional, Peragallo, Jason H., additional, Brower, Judy L., additional, Raghuram, Aparna, additional, Al Wattar, Bilal, additional, Chinn, Ryan, additional, Kothari, Srishti, additional, Siatkowski, R. Michael, additional, Lim, Maria E., additional, Brewer, Alisha N., additional, Doughty, Annette M., additional, Icks, Sonny W., additional, Almeida, Shannon, additional, de Alba Campomanes, Alejandra, additional, Banwait, Premilla, additional, Hajkazemshirazi, Leila, additional, Bastea-Forte, Yizhuo, additional, Arjona, Jennifer K., additional, Chen, Jeremy, additional, Cooper, Karen, additional, Ghadban, Rafif, additional, Chung, Sophia M., additional, Cruz, Oscar A., additional, Christenson, Traci A., additional, Breeding, Lisa L., additional, Govreau, Dawn M., additional, Wallis, Beth A., additional, Geddie, Brooke E., additional, Wolinski, Elisabeth T., additional, Rudaitis, Indre M., additional, Twite, Jacqueline, additional, Bloomquist, Carrie S., additional, Laboy, Sarah R., additional, Twite, Jackie M., additional, Pineles, Stacy L., additional, Doan, Michelle V., additional, Bernardo, Marianne J., additional, Brodsky, Michael C., additional, Chen, John J., additional, Wernimont, Suzanne M., additional, Czaplewski, Lindsay L., additional, Eastman, Stacy L., additional, Keehn, Moriah A., additional, Priebe, Debbie M., additional, Bremer, Don L., additional, Golden, Richard P., additional, Jordan, Catherine O., additional, McGregor, Mary Lou, additional, Reem, Rachel E., additional, Rogers, David L., additional, Schreckengost, Amanda N., additional, Maletic, Sara A., additional, Dairi, Mays A., additional, Enyedi, Laura B., additional, Jones, Sarah K., additional, Barman, Navajyoti R., additional, House, Robert J., additional, Nasrazadani, David A., additional, Gratton, Sean M., additional, Marsh, Justin D., additional, Dent, Rebecca J., additional, Bond, Lezlie L., additional, Soske, Lori L., additional, Sudhakar, Padmaja, additional, Willen, Christi M., additional, Taylor, Deborah, additional, Moliterno, Nathaniel Q., additional, Nsoesie, Michael, additional, Vally, Shaista, additional, Phillips, Paul H., additional, Lowery, Robert S., additional, Colon, Beth, additional, Stotts, Nancy L., additional, To, Kelly D., additional, McClelland, Collin M., additional, Areaux, Raymond G., additional, Holleschau, Ann M., additional, Merrill, Kim S., additional, Ospina, Luis H., additional, Superstein, Rosanne, additional, Thibeault, Maryse, additional, Gagnon, Helene, additional, Donahue, Sean P., additional, Ruark, Scott T., additional, Fraine, Lisa A., additional, Sprouse, Petrice A., additional, Biernacki, Ronald J., additional, Avery, Robert A., additional, Forbes, Brian J., additional, Jivraj, Imran, additional, Kohli, Anita A., additional, Richter, Meg M., additional, Baumritter, Agnieshka, additional, Mitchell, Ellen B., additional, Nischal, Ken K., additional, Runkel, Lauren M., additional, Blaha, Bianca, additional, Churchfield, Whitney, additional, Fulwylie, Christina, additional, Ko, Melissa W., additional, Mejico, Luis J., additional, Iqbal, Muhammad, additional, Attanasio, Catherine E., additional, Deb, Lena F., additional, Goodrich, Courtney B., additional, Hartwell, Alisha M., additional, Moore, Jennifer A., additional, Bohra, Lisa, additional, Apkarian, Alexandra O., additional, Gianfermi, Elena M., additional, Roarty, John D., additional, Rotberg, Leemor B., additional, Perzyk, Susan N., additional, Beck, Roy W., additional, Austin, Darrell S., additional, Boyle, Nicole M., additional, Chandler, Danielle L., additional, Connelly, Patricia L., additional, Conner, Courtney L., additional, Dean, Trevano W., additional, Donahue, Quayleen, additional, Fimbel, Brooke P., additional, Hercinovic, Amra, additional, Hoepner, James E., additional, Kaplon, Joseph D., additional, Li, Zhuokai, additional, Ortiz, Gillaine, additional, Robinson, Julianne L., additional, Stutz, Kathleen M., additional, Toro, David O., additional, Woodard, Victoria C., additional, Wu, Rui, additional, Balcer, Laura, additional, Kupersmith, Mark, additional, Lazar, Elizabeth L., additional, Waldman, Amy, additional, Wallace, David K., additional, Birch, Eileen E., additional, Chen, Angela M., additional, Christiansen, Stephen P., additional, Erzurum, S. Ayse, additional, Everett, Donald F., additional, Freedman, Sharon F., additional, Good, William V., additional, Lee, Katherine A., additional, London, Richard, additional, Manh, Vivian M., additional, Manny, Ruth E., additional, Morrison, David G., additional, Schweinler, Bonita R., additional, Silver, Jayne L., additional, Verderber, Lisa C., additional, Weise, Katherine K., additional, Green, Ari, additional, Diener-West, Marie, additional, Baker, John D., additional, Davis, Barry, additional, Phelps, Dale L., additional, Poff, Stephen W., additional, Saunders, Richard A., additional, and Tychsen, Lawrence, additional

Published
2022
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