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4. Stain Normalization of Hematology Slides using Neural Color Transfer

Author

Arshad, M. Muneeb, Sajid, Hasan, and Khan, M. Jawad

Subjects
Electrical Engineering and Systems Science - Image and Video Processing
Abstract

Deep learning is popularly used for analyzing pathology images, but variations in image properties can limit the effectiveness of the models. The study aims to develop a method that transfers the variability present in the training set to unseen images, improving the model's ability to make accurate inferences. YOLOv5 was trained on peripheral blood and bone marrow sample images and Neural Color Transfer techniques were used to incorporate invariance. The results showed significant improvement in detecting WBCs from untrained samples after normalization, highlighting the potential of deep learning-based normalization techniques for inference robustness.

Published
2024

5. AttDiCNN: Attentive Dilated Convolutional Neural Network for Automatic Sleep Staging using Visibility Graph and Force-directed Layout

Author

Jobayer, Md, Shawon, Md. Mehedi Hasan, Mahmud, Tasfin, Antor, Md. Borhan Uddin, and Chowdhury, Arshad M.

Subjects
Electrical Engineering and Systems Science - Signal Processing, Computer Science - Computer Vision and Pattern Recognition, Computer Science - Human-Computer Interaction, Computer Science - Machine Learning
Abstract

Sleep stages play an essential role in the identification of sleep patterns and the diagnosis of sleep disorders. In this study, we present an automated sleep stage classifier termed the Attentive Dilated Convolutional Neural Network (AttDiCNN), which uses deep learning methodologies to address challenges related to data heterogeneity, computational complexity, and reliable automatic sleep staging. We employed a force-directed layout based on the visibility graph to capture the most significant information from the EEG signals, representing the spatial-temporal features. The proposed network consists of three compositors: the Localized Spatial Feature Extraction Network (LSFE), the Spatio-Temporal-Temporal Long Retention Network (S2TLR), and the Global Averaging Attention Network (G2A). The LSFE is tasked with capturing spatial information from sleep data, the S2TLR is designed to extract the most pertinent information in long-term contexts, and the G2A reduces computational overhead by aggregating information from the LSFE and S2TLR. We evaluated the performance of our model on three comprehensive and publicly accessible datasets, achieving state-of-the-art accuracy of 98.56%, 99.66%, and 99.08% for the EDFX, HMC, and NCH datasets, respectively, yet maintaining a low computational complexity with 1.4 M parameters. The results substantiate that our proposed architecture surpasses existing methodologies in several performance metrics, thus proving its potential as an automated tool in clinical settings., Comment: In review to IEEEtrans NNLS; 15-pages main paper and 3-pages supplementary material

Published
2024

9. Factors affecting minimally invasive surgery utilization during elective colectomies for diverticular disease in the United States

Author

Arshad M. Bachelani and Laura A. Holton

Subjects
Diverticular disease, Minimally invasive surgery, Disparities, Surgery, RD1-811
Abstract

Background: Compared with open surgery, minimally invasive surgery (MIS) has been shown to have improved outcomes when treating diverticular disease. This study aimed to analyze recent trends in MIS utilization for elective colectomy for diverticular disease and to identify individual variables and hospital characteristics associated with MIS utilization. Methods: This population-based study examined individuals from the National Inpatient Sample who underwent elective colectomy for diverticular disease from 2016 to 2019. Results: Hospitals in the Midwest used MIS less than those in other geographic regions. Rural hospitals used MIS less than urban hospitals. Hospital bed size and teaching status were not associated with differences in MIS utilization. Patients with private insurance were more likely to have an MIS operation. There was also a racial disparity in MIS utilization, even after adjusting for insurance status. Conclusions: While there is no longer any variance in MIS utilization based on hospital bed size or teaching status, disparities concerning patient race remain, even after adjusting for insurance status. Further investigation is needed to determine the roots of these disparities.

Published
2024
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12. The real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study – 6 month results

Author

Khanani, Arshad M., Aziz, Aamir A., Khan, Hannah, Gupta, Ashwin, Mojumder, Ohidul, Saulebayeva, Aigerim, Abbey, Ashkan M., Almeida, David R. P., Avery, Robert L., Banda, Himanshu K., Barakat, Mark R., Bhandari, Ramanath, Chang, Emmanuel Y., Haug, Sara J., London, Nikolas J. S., Mein, Luke, Sheth, Veeral S., Wolfe, Jeremy D., Singer, Michael A., and Danzig, Carl J.

Published
2023
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13. Review of real-world evidence of dual inhibition of VEGF-A and ANG-2 with faricimab in NAMD and DME

Author

Fernando M Penha, Maliha Masud, Zoha A. Khanani, Mathew Thomas, Rodney D. Fong, Kyler Smith, Avishay Chand, Majid Khan, Greggory Gahn, Gustavo Barreto Melo, and Arshad M. Khanani

Subjects
Anti-VEGF-A, Angiopoietin 2, Neovascular age-related macular degeneration, Diabetic macular edema, Faricimab, Aflibercept, Ophthalmology, RE1-994
Abstract

Abstract Management of vitreoretinal disorders (e.g., neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) have assumed the standard therapy of lifelong anti-VEGF injections with drugs like aflibercept, brolucizumab, ranibizumab and bevacizumab. However, the burden imposed on patients is a major deterrent for continual therapy and recovery. Faricimab, a bispecific antibody, blocking both VEGF-A and Ang-2 molecules, produces a comparable functional and anatomical results, with less injections, significantly reducing patient burden. Visual acuity, safety, adverse effects, and anatomical outcomes are discussed in the pivotal clinical trials (YOSEMITE/RHINE and TENAYA/LUCERNE), and early data from real-world studies (TRUCKEE, TAHOE, FARWIDE-DME, FARETINA and others). In YOSEMITE and RHINE, faricimab demonstrated non-inferior vision gains, better anatomical outcomes compared to aflibercept every 8 weeks. Faricimab in the personalized treatment interval (PTI), after week 96, achieved 12-week interval in 78.1% of the patients and 16-week interval in 62.3%. TENAYA and LUCERNE reported comparable best corrected visual acuity (BCVA) improvement and better anatomic outcomes during head-to-head phase, parallel to aflibercept, at its 8-week treatment schedule. Faricimab in the PTI regimen, after week 96 achieved 12-week interval in 77.8% of the patients and 16-week interval in 63.1%. Safety of faricimab has been comparable to aflibercept in these pivotal trials. Real-world data supports the data from the pivotal studies regarding the efficacy and safety profile of faricimab in heterogenous real world patient population. Moreover, in previously treated patients, it also demonstrated a faster fluid resolution, good safety profile. Considering faricimab has demonstrated anatomic and durability benefit in the treatment of nAMD and DME, additional data from ongoing extension clinical trials, AVONELLE-X and RHONE-X will help understand longer term outcomes for patients treated with faricimab as well as patients switching from aflibercept to faricimab after finishing the pivotal trials. Longer term data from the real-world studies will also continue to contribute to our understanding of long-term efficacy, safety and durability in the real world patient population.

Published
2024
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14. Linear and nonlinear analysis of Ion-Temperature-Gradient (ITG) Driven mode in the asymmetric Pair-Ion Magnetoplasma

Author

Razzaq, Javaria, Ehsan, Zahida, and Mirza, Arshad M.

Subjects
Physics - Plasma Physics
Abstract

We have investigated linear and nonlinear dynamics of ion-temperature-gradient driven drift mode for Maxwellian and non Maxwellian pair-ion plasma embedded in an inhomogeneous magnetic field having gradients in ion's temperature and number density. Linear dispersion relations are derived and analyzed analytically as well as numerically for different cases. It has been found that growth rate of instability increases with increasing eta. By using the transport equations of Braginskii, model, a set of nonlinear equations are derived. In the nonlinear regime, soliton structures are found to exist. Our numerical analysis shows that amplitude of solitary waves increases by increasing ion to electron number density ratio. These solitary structures are also found to be sensitive to non thermal kappa and Cairns distributed electrons. Our present work may contribute a good illustration of the observation of nonlinear solitary waves driven by the ITG mode in magnetically confined pair-ion plasmas and space pair-ion plasmas as the formation of localized structures along drift modes is one of the striking reasons for L-H transition in the region of improved confinements in magnetically confined devices like tokamaks., Comment: 18

Published
2022
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15. 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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19. Bispecific VEGF-A and Angiopoietin-2 Antagonist RO-101 Preclinical Efficacy in Model of Neovascular Eye Disease

Author

Xu, Li, Prentice, Jessi R., Velez-Montoya, Raul, Sinha, Alina, Barakat, Mark R., Gupta, Ashwin, Lowenthal, Robert, Khanani, Arshad M., Kaiser, Peter K., Heier, Jeffrey S., Jones, Anthony, Morgenstern, Joshua L., Strong Caldwell, Anne, Mueller, Niklaus, Quiroz-Mercado, Hugo, Huvard, Michael, Olson, Jeffrey L., Bhatt, Ramesh, and Bhandari, Ramanath

Published
2024
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21. Gains in the current understanding of managing neovascular AMD with brolucizumab

Author

Bahram Bodaghi, Arshad M. Khanani, Ramin Khoramnia, Carlos Pavesio, and Quan Dong Nguyen

Subjects
Ophthalmology, RE1-994
Abstract

Abstract Background Unresolved retinal fluid and high injection burden are major challenges for patients with neovascular age-related macular degeneration. Brolucizumab addresses these challenges by providing robust vision gains and superior fluid resolution, with the potential for longer treatment intervals. Brolucizumab has been associated with adverse events of retinal vasculitis and retinal vascular occlusion typically in the presence of intraocular inflammation (IOI). To define the incidence of the adverse events, Novartis convened an external safety review committee, which found a rate of 4.6% for definite or probable IOI, 3.3% for retinal vasculitis, and 2.1% for retinal vascular occlusion in the HAWK and HARRIER trials. Novartis also established a coalition to explore 4 areas regarding the adverse events: root cause, patient characterization, event mitigation and vigilance, and treatment protocols for the adverse events. Based on the coalition findings, a risk mitigation framework was developed. Prior to initiating treatment with brolucizumab, it is important to weigh the potential benefit against risk of adverse events and to consider patient risk factors such as prior history of IOI and/or retinal vascular occlusion. To mitigate the potential for IOI-related adverse events, it is important to conduct a thorough dilated eye examination before each injection and closely monitor patients throughout treatment. Patients should be educated on symptoms of IOI to monitor for. Brolucizumab should not be injected in the presence of active IOI. If an adverse event is identified, prompt and intensive treatment should be considered. Conclusion Progress has been made in understanding how to mitigate IOI-related adverse events following treatment with brolucizumab.

Published
2023
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22. SUPRACHOROIDAL SPACE INJECTION TECHNIQUE: Expert Panel Guidance

Author

Wykoff, Charles C., Avery, Robert L., Barakat, Mark R., Boyer, David S., Brown, David M., Brucker, Alexander J., Cunningham, Emmett T., Jr, Heier, Jeffrey S., Holekamp, Nancy M., Kaiser, Peter K., Khanani, Arshad M., Kim, Judy E., Demirci, Hakan, Regillo, Carl D., Yiu, Glenn C., and Ciulla, Thomas A.

Published
2024
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23. Record-Based Transmuted Generalized Linear Exponential Distribution with Increasing, Decreasing and Bathtub Shaped Failure Rates

Author

Arshad, M., Khetan, M., Kumar, V., and Pathak, A. K.

Subjects
Mathematics - Statistics Theory, Statistics - Applications, 62E15, 62F10, 62N05
Abstract

The linear exponential distribution is a generalization of the exponential and Rayleigh distributions. This distribution is one of the best models to fit data with increasing failure rate (IFR). But it does not provide a reasonable fit for modeling data with decreasing failure rate (DFR) and bathtub shaped failure rate (BTFR). To overcome this drawback, we propose a new record-based transmuted generalized linear exponential (RTGLE) distribution by using the technique of Balakrishnan and He (2021). The family of RTGLE distributions is more flexible to fit the data sets with IFR, DFR, and BTFR, and also generalizes several well-known models as well as some new record-based transmuted models. This paper aims to study the statistical properties of RTGLE distribution, like, the shape of the probability density function and hazard function, quantile function and its applications, moments and its generating function, order and record statistics, Renyi entropy. The maximum likelihood estimators, least squares and weighted least squares estimators, Anderson-Darling estimators, Cramer-von Mises estimators of the unknown parameters are constructed and their biases and mean squared errors are reported via Monte Carlo simulation study. Finally, the real data set based on failure time illustrates the goodness of fit and applicability of the proposed distribution; hence, suitable recommendations are forwarded., Comment: 29 pages, 5 figures, 9 tables

Published
2021

29. Systems genetics identifies miRNA-mediated regulation of host response in COVID-19

Author

Gjorgjieva, T., Chaloemtoem, A., Shahin, T., Bayaraa, O., Dieng, M. M., Alshaikh, M., Abdalbaqi, M., Del Monte, J., Begum, G., Leonor, C., Manikandan, V., Drou, N., Arshad, M., Arnoux, M., Kumar, N., Jabari, A., Abdulle, A., ElGhazali, G., Ali, R., Shaheen, S. Y., Abdalla, J., Piano, F., Gunsalus, K. C., Daggag, H., Al Nahdi, H., Abuzeid, H., and Idaghdour, Y.

Published
2023
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30. Design optimization and validation of UV-C illumination chamber for filtering facepiece respirators

Author

Abu S.M. Mohsin, Mohd. Raeed Jamiruddin, Md Mahmudul Kabir Peyal, Shahana Sharmin, Ashfaq Ahmed, Afrin Hossain Puspita, A.A.M. Sharfuddin, Afrida Malik, Al Hasib, Sanjida Akter Suchona, Arshad M. Chowdhury, and Eva Rahman Kabir

Subjects
UV-C illumination chamber, SAR-CoV-2 virus, Facepiece respirators, Personal protection equipment (PPE), Decontamination efficacy, Biological decontamination and pathogens, Science (General), Q1-390, Social sciences (General), H1-99
Abstract

In this study, we constructed an UV-C illumination chamber using commercially available germicidal lamps and other locally available low-cost components for general-purpose biological decontamination purposes. The illumination chamber provides uniform illumination of around 1 J/cm2 in under 5 min across the chamber. The control mechanism was developed to automate the on/off process and make it more secure minimizing health and other electrical safety. To validate the decontamination efficacy of the UV-C Illumination Chamber we performed the Geobacillus spore strip culture assay. Additionally, we performed the viral load measurement by identifying the COVID-19-specific N-gene and ORF1 gene on surgical masks. The gold standard RT-qPCR measurement was performed to detect and quantify the COVID-19-specific gene on the mask sample. The biochemical assay was conducted on the control and test group to identify the presence of different types of bacteria, and fungi before and after exposure under the illumination chamber. The findings of our study revealed satisfactory decontamination efficacy test results. Therefore, it could be an excellent device in healthcare settings as a disinfection tool for biological decontamination such as SAR-CoV-2 virus, personal protection equipment (PPE), (including n95, k95 respirators, and surgical masks), and other common pathogens.

Published
2024
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31. Safety and efficacy of ixoberogene soroparvovec in neovascular age-related macular degeneration in the United States (OPTIC): a prospective, two-year, multicentre phase 1 studyResearch in context

Author

Arshad M. Khanani, David S. Boyer, Charles C. Wykoff, Carl D. Regillo, Brandon G. Busbee, Dante Pieramici, Carl J. Danzig, Brian C. Joondeph, James C. Major, Jr., Adam Turpcu, and Szilárd Kiss

Subjects
Neovascular age-related macular degeneration, Gene therapy, Anti-VEGF, Ixoberogene soroparvovec, Medicine (General), R5-920
Abstract

Summary: Background: Gene therapy, successfully used in rare, monogenetic disorders, may prove to be a durable management approach for common, polygenetic conditions, including neovascular age-related macular degeneration (nAMD). Repeated injections, oftentimes monthly, and possibly for decades, of vascular endothelial growth factor antagonists (anti-VEGF), is the standard for nAMD. We hypothesised that an in-office, intravitreal administration of ixoberogene soroparvovec (ixo-vec, formerly ADVM-022), a single-dose gene therapy encoding for the proven anti-VEGF protein, aflibercept, would transform retinal cells to continually produce aflibercept to minimise treatment burden in nAMD. Methods: In this two-year, open-label, prospective, multicentre phase 1 study, patients with nAMD responding to anti-VEGF were assigned to four cohorts differing by ixo-vec dose (2 × 1011 vs 6 × 1011 vector genomes (vg/eye)) and prophylactic steroids (oral prednisone vs topical difluprednate). The primary outcome was the type, severity, and incidence of ocular and systemic adverse events (AEs); secondary endpoints included vision, central subfield thickness (CST), and the number of supplemental injections. This study was registered with ClinicalTrials.gov, NCT03748784. Findings: Thirty patients with nAMD were enrolled between November 14, 2018 and June 30, 2020 at nine study sites in the United States. No systemic ixo-vec related AEs were noted. Across both dose groups the most common adverse event was anterior chamber cell, which was reported in 11 participants in the 6 × 1011 dose group and in 7 participants in the 2 × 1011 dose group; intraocular inflammation was responsive to topical corticosteroids, with no anterior chamber cells or vitreous cells observed in 2 × 1011 vg/eye patients at the end of the study. Vision and CST remained stable throughout two years with annualised anti-VEGF injections reduced by 80% (10.0 mean annualised anti-VEGF injections to 1.9) in 2 × 1011 vg/eye and 98% (9.8 mean annualised anti-VEGF injections to 0.2) in 6 × 1011 vg/eye cohorts. Interpretation: Ixo-vec was generally well-tolerated, maintained vision, and improved anatomical outcomes in nAMD, with a substantial reduction in anti-VEGF injections. A single administration of an in-office gene therapy, with vectorised protein with an already established clinical benefit, has the potential to revolutionise the management of common ocular disorders requiring ongoing, frequent therapeutic interventions. Funding: Adverum Biotechnologies.

Published
2024
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32. Review of gene therapies for age-related macular degeneration

Author

Khanani, Arshad M, Thomas, Mathew J, Aziz, Aamir A, Weng, Christina Y, Danzig, Carl J, Yiu, Glenn, Kiss, Szilárd, Waheed, Nadia K, and Kaiser, Peter K

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Neurosciences, Eye Disease and Disorders of Vision, Neurodegenerative, Gene Therapy, Genetics, Macular Degeneration, Biotechnology, Aging, Eye, Genetic Therapy, Geographic Atrophy, Humans, Clinical Sciences, Immunology, Opthalmology and Optometry, Ophthalmology & Optometry, Ophthalmology and optometry
Abstract

Gene therapies aim to deliver a therapeutic payload to specified tissues with underlying protein deficiency. Since the 1990s, gene therapies have been explored as potential treatments for chronic conditions requiring lifetime care and medical management. Ocular gene therapies target a range of ocular disorders, but retinal diseases are of particular importance due to the prevalence of retinal disease and the current treatment burden of such diseases on affected patients, as well as the challenge of properly delivering these therapies to the target tissue. The purpose of this review is to provide an update on the most current data available for five different retinal gene therapies currently undergoing clinical trials for use against age-related macular degeneration (AMD) and the development of novel delivery routes for the administration of such therapies. Research has been performed and compiled from PubMed and the select authors of this manuscript on the treatment and effectiveness of five current retinal gene therapies: Luxturna, ADVM-022, RGX-314, GT-005, and HMR59. We present the available data of current clinical trials for the treatment of neovascular and dry age-related macular degeneration with different AAV-based gene therapies. We also present current research on the progress of developing novel routes of administration for ocular gene therapies. Retinal gene therapies offer the potential for life-changing treatment for chronic conditions like age-related macular degeneration with a single administration. In doing so, gene therapies change the landscape of treatment options for these chronic conditions for both patient and provider.

Published
2022

33. Can intravitreal injections with higher volume cause higher intraocular eye pressure? Considerations for anti-complement injections in normal and glaucomatous eyes

Author

Carsten H. Meyer, Gustavo Barreto Melo, and Arshad M. Khanani

Subjects
Avacincaptad pegol, Glaucoma, Intraocular pressure, Pegcetacoplan, Retinal nerve fiber layer, Ophthalmology, RE1-994
Abstract

Abstract The approval of Syfovre® (pegcetacoplan) and Iverzay® (avacincaptad pegol) for the treatment of geographic atrophy (GA) marks a significant advancement in retinal disease therapy, offering both complement 3 and complement 5 inhibitors. With this breakthrough, an increase in intravitreal injections (IVI) is expected to treat GA, raising questions about potential effects on intraocular pressure (IOP). This concern is exacerbated by the larger injection volume required for GA treatment, potentially impacting IOP. Previous studies have shown that IVI can lead to a temporary increase in IOP with a 0.05 ml injection. This transient elevation is challenging to manage with glaucoma drops, and a preventive approach, such as paracentesis immediately before IVIs, may be more effective. Despite concerns, clinical significance and long-term effects of IOP changes with a 0.05 ml injection remain uncertain. To address these concerns, routine evaluations including macular optical coherence tomography (OCT), fundus autofluorescence, IOP measurements, and retinal nerve fiber layer OCT before the first IVI with avacincaptad pegol and pegcetacoplan are recommended to detect potential changes early. Further research is needed to determine the extent to which IOP changes impact GA patients and whether cumulative effects occur with repeated IVIs, especially in those with additional eye conditions.

Published
2023
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44. COVID-19 Stroke Apical Lung Examination Study 2: a national prospective CTA biomarker study of the lung apices, in patients presenting with suspected acute stroke (COVID SALES 2)

Author

Ratneswaren, T., Chan, N., Aeron-Thomas, J., Sait, S., Adesalu, O., Alhawamdeh, M., Benger, M., Garnham, J., Dixon, L., Tona, F., McNamara, C., Taylor, E., Lobotesis, K., Lim, E., Goldberg, O., Asmar, N., Evbuomwan, O., Banerjee, S., Holm-Mercer, L., Senor, J., Tsitsiou, Y., Tantrige, P., Taha, A., Ballal, K., Mattar, A., Daadipour, A., Elfergani, K., Barker, R., Chakravartty, R., Murchison, A.G., Kemp, B.J., Simister, R., Davagnanam, I., Wong, O.Y., Werring, D., Banaras, A., Anjari, M., Mak, J.K.C., Falzon, A.M., Rodrigues, J.C.L., Thompson, C.A.S., Haines, I.R., Burnett, T.A., Zaher, R.E.Y., Reay, V.L., Banerjee, M., Sew Hee, C.S.L., Oo, A.P., Lo, A., Rogers, P., Hughes, T., Marin, A., Mukherjee, S., Jaber, H., Sanders, E., Owen, S., Bhandari, M., Sundayi, S., Bhagat, A., Elsakka, M., Hashmi, O.H., Lymbouris, M., Gurung-Koney, Y., Arshad, M., Hasan, I., Singh, N., Patel, V., Rahiminejad, M., and Booth, T.C.

Published
2024
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