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1. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials

Author

Cole, Abosede O, Gerstenblith, Adam T, Kotagiri, Ajay, Edwards, Albert O, Zambrano, Alberto D, Eaton, Alexander M, Rubowitz, Alexander, Lyon, Alice T, Chiang, Allen, Ho, Allen, Hu, Allen Y, Guerami, Amir H, Dessouki, Amr L, de Carvalho, André Corrêa Maia, Emanuelli, Andrés, Chang, Andrew A, Antoszyk, Andrew N, Francone, Anibal Andrés, Prasad, Anita, Wolf, Armin, Khanani, Arshad M, Abbey, Ashkan Michael, Moulana, Asma, Wihelm, Barbara, Sikorski, Bartosz L, Kuppermann, Baruch D, Wolff, Benjamin, Jewart, Brian H, Do, Brian K, Chan-Kai, Brian T, Mein, Calvin, Hoyng, Carel B, Awh, Carl C, Regillio, Carl, Zeolite, Carlos, Baumal, Caroline R, Creuzot-Garcher, Catherine, Maury, Catherine Français, Wykoff, Charles C, Newell, Charles K, Jhaveri, Chirag, Lohmann, Chris P, Dinah, Christiana B, Ma, Colin, Crawford, Courtney, Parke, D Wilkin, Lavinsky, Daniel, Roth, Daniel, Pieramici, Dante J, Moshfeghi, Darius M, Levin, Darrin, Saperstein, David A, Brown, David, Gaucher, David, Lally, David R, Liao, David S, Brown, David Warren, Goldstein, Debra, Marcus, Dennis, Chan, Derek G, Dhoot, Dilsher, Tacite, Domingo, Zalewski, Dominik, Espana, Edgar M, Lad, Eleonora M, Souied, Eric H, Suan, Eric P, Eting, Eva, Sola, Federico Furno, de Bats, Flore, Bandello, Francesco, Gómez-Ulla, Francisco, Devin, François, Holz, Frank G, Chen, Fred K, Makkouk, Fuad, Dyer, Gawain, Spital, George, Staurenghi, Giovanni, Stoller, Glenn, Cousins, Gwen, Salehi-Had, Hani, Agostini, Hansjürgen, Eleftheriadis, Haralabos, Weiss, Harold, Sultan, Harris C, Massé, Hélène, Pearce, Ian, Dias, Indra, Barbazetto, Irene, Rosenblatt, Irit, Suñer, Ivan J, Kovach, Jaclyn L, Kaluzny, Jakub, Borthwick, James, Howard, James G, Wong, James, Ernest, Jan, Němčanský, Jan, Ysasaga, Jason Edward, Handza, Jason M, Moreno, Javier Antonio Montero, Korobelnik, Jean-François, Heier, Jeffrey S, Arnold, Jennifer J, Brown, Jeremiah, Bafalluy, Joaquin, Pearlman, Joel, Pitcher, John D, Kitchens, John, Carlson, John P, Gilhotra, Jolly, Fein, Jordana, Monés, Jordi M, Luna, José Domingo, Moreno, José María Ruiz, Coney, Joseph M, Sallum, Juliana Maria Ferraz, Olsen, Karl R, Blobner, Katharina, Macoul, Katherine A, Oh, Kean T, Malik, Khurram Javed, Hattenbach, Lars-Olof, Kodjikian, Laurent, Neto, Laurentino Biccas, Singerman, Lawrence J, Altay, Lebriz, Sheck, Leo-H, Feiner, Leonard, Harris, Lindsey D, Chishold, Lionel D, Rao, Llewelyn J, Nehemy, Márcio Bittar, Elizalde, Maria Jose Capella, Gamulescu, Maria-Andreea, Saravia, Mario J, Johnson, Mark W, McKibbin, Martin, Maccumber, Mathew, Vidosevich, Matko, Ohr, Matthew P, Samuel, Michael A, Singer, Michael A, Cassell, Michael, Dollin, Michael, Elman, Michael J, Ip, Michael S, Goldstein, Michaella, Busquets, Miguel, Mititelu, Mihai, Shah, Milan, Veith, Miroslav, Fineman, Mitchell, Varano, Monica, Christmas, Nancy, Steinle, Nathan C, Chaudhry, Nauman, Chinskey, Nicholas D, Eter, Nicole, London, Nikolas J S, Mathalone, Nurit, Schlottmann, Patricio G, Coady, Patrick, Higgins, Patrick M, Raskauskas, Paul A, Yates, Paul A, Bernstein, Paul, Mitchell, Paul, Monsour, Paul, Raphaelian, Paul V, Stanga, Paulo E, Stodulka, Pavel, Issa, Peter Charbel, Pavan, Peter, Ferrone, Phil J, Oleksy, Piotr, Abraham, Prema, Mruthyunjaya, Prithvi, Nguyen, Quan Dong, Reddy, Rahul K, Khurana, Rahul N, Tuli, Raman, Tadayoni, Ramin, Katz, Randy Steven, Arora, Rashi, Schlingemann, Reinier O, Rosen, Richard B, Gale, Richard, Scartozzi, Richard, Isernharge, Ricky, Singh, Rishi P, Stoltz, Robert A, Avery, Robert L, Wirthlin, Robert S, Guymer, Robyn, Goldberg, Roger A, Frenkel, Ronald, Belfort, Rubens Jr, Mohand-Said, Saddek, Grisanti, Salvatore, Razavi, Sam, Fraser-Bell, Samantha, Shah, Sandeep N, Wickremasinghe, Sanjeewa, Haug, Sara Joy, Adrean, Sean D, Priglinger, Siegfried G, Esposti, Simona Degli, Guest, Stephen, Huddleston, Stephen, Itty, Sujit, Moon, Suk Jin, Bhatia, Sumit P, Gupta, Sunil, Patel, Sunil S, Garg, Sunir J, Joshi, Sunir, Nghiem-Buffet, Sylvia, Johnson, T Mark, Jaouni, Tareq, Ach, Thomas, Williams, Thomas R, Sheidow, Thomas, Cleland, Timothy P, You, Timothy T, Peto, Tunde, Konidaris, Vasileios, Gonzalez, Victor H, Korda, Vladimir, Freeman, William R, Bridges, William Z, Barak, Yoreh, Zagorski, Zbigniew, Yehoshua, Zohar, Dubska, Zora, Rosenfeld, Philip J, Guymer, Robyn H, Boyer, David, Grossi, Federico, Korobelnik, Jean-Francois, Slakter, Jason S, Waheed, Nadia K, Metlapally, Ravi, Steinle, Nathan, Francone, Anibal A, Hu, Allen, Deschatelets, Pascal, Francois, Cedric, Bliss, Caleb, Monés, Jordi, and Ribeiro, Ramiro

Published
2023
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3. Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial

Author

Ahfat, Frank, Bhatnagar, Ajay, Narendran, Nirodhini, Chavan, Randhir, Cole, Abosede, Crosby-Nwaobi, Roxanne, Patrao, Namritha, Menon, Deepthy, Hogg, Chris, Rubin, Gary, Leitch-Devlin, Lauren, Egan, Catherine, Shah, Nisha, Mansour, Tatiana, Peto, Tunde, Eleftheriadis, Haralabos, Gibson, Joanathan, Ghulakhszian, Arevik, Vafidis, Gilli, Hughes, Edward, Jafree, Afsar, Menon, Geeta, Prakash, Priya, Sandinha, Maria, Smith, Richard, Scanlon, Peter, Chave, Steve, Aldington, Steve, Dale, Angela, Hood, Gillian, Hitman, Graham A, Crabb, David, Denniston, Alaistair, Lewin, Douglas, Grierson, Ian, Walker, Sarah, Sturt, Jackie, Sahu, Debendra, Sivaprasad, Sobha, Vasconcelos, Joana C, Prevost, A Toby, Holmes, Helen, Hykin, Philip, George, Sheena, Murphy, Caroline, Kelly, Joanna, and Arden, Geoffrey B

Published
2018
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5. Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial

Author

Lois, Noemi, Gardner, Evie, Waugh, Norman, Azuara-Blanco, Augusto, Mistry, Hema, McAuley, Danny, Acharya, Nachiketa, Aslam, Tariq M., Bailey, Clare, Chong, Victor, Downey, Louise, Eleftheriadis, Haralabos, Fatum, Samia, George, Sheena, Ghanchi, Faruque, Groppe, Markus, Hamilton, Robin, Menon, Geeta, Saad, Ahmed, Sivaprasad, Sobha, Shiew, Marianne, Steel, David H., Talks, James Stephen, Adams, Catherine, Campbell, Christina, Mills, Matthew, Clarke, Mike, and On behalf of the DIAMONDS Study Group

Published
2019
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6. Diabetic Macular Edema and Diode Subthreshold Micropulse Laser

Author

Lois, Noemi, primary, Campbell, Christina, additional, Waugh, Norman, additional, Azuara-Blanco, Augusto, additional, Maredza, Mandy, additional, Mistry, Hema, additional, McAuley, Danny, additional, Acharya, Nachiketa, additional, Aslam, Tariq M., additional, Bailey, Clare, additional, Chong, Victor, additional, Downey, Louise, additional, Eleftheriadis, Haralabos, additional, Fatum, Samia, additional, George, Sheena, additional, Ghanchi, Faruque, additional, Groppe, Markus, additional, Hamilton, Robin, additional, Menon, Geeta, additional, Saad, Ahmed, additional, Sivaprasad, Sobha, additional, Shiew, Marianne, additional, Steel, David H., additional, Talks, James Stephen, additional, Doherty, Paul, additional, McDowell, Cliona, additional, and Clarke, Mike, additional

Published
2023
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7. Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT

Author

Lois, Noemi, primary, Campbell, Christina, additional, Waugh, Norman, additional, Azuara-Blanco, Augusto, additional, Maredza, Mandy, additional, Mistry, Hema, additional, McAuley, Danny, additional, Acharya, Nachiketa, additional, Aslam, Tariq M, additional, Bailey, Clare, additional, Chong, Victor, additional, Downey, Louise, additional, Eleftheriadis, Haralabos, additional, Fatum, Samia, additional, George, Sheena, additional, Ghanchi, Faruque, additional, Groppe, Markus, additional, Hamilton, Robin, additional, Menon, Geeta, additional, Saad, Ahmed, additional, Sivaprasad, Sobha, additional, Shiew, Marianne, additional, Steel, David H, additional, Talks, James Stephen, additional, Doherty, Paul, additional, McDowell, Clíona, additional, and Clarke, Mike, additional

Published
2022
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8. Diabetic macular edema and diode subthreshold micropulse laser: A randomized double-masked noninferiority clinical trial

Author

Lois, Noemi, Campbell, Christina, Waugh, Norman, Azuara-Blanco, Augusto, Maredza, Mandy, Mistry, Hema, McAuley, Danny, Acharya, Nachiketa, Aslam, Tariq M., Bailey, Clare, Chong, Victor, Downey, Louise, Eleftheriadis, Haralabos, Fatum, Samia, George, Sheena, Ghanchi, Faruque, Groppe, Markus, Hamilton, Robin, Menon, Geeta, Saad, Ahmed, Sivaprasad, Sobha, Shiew, Marianne, Steel, David H., Talks, James Stephen, Doherty, Paul, McDowell, Cliona, and Clarke, Mike

Subjects
SDG 3 - Good Health and Well-being
Abstract

PurposeTo determine clinical effectiveness, safety, and cost-effectiveness of subthreshold micropulse laser (SML), compared with standard laser (SL), for diabetic macular edema (DME) with central retinal thickness (CRT) < 400 μm.DesignPragmatic, multicenter, allocation-concealed, double-masked, randomized, noninferiority trial.ParticipantsAdults with center-involved DME < 400 μm and best-corrected visual acuity (BCVA) of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in one/both eyes.MethodsRandomization 1:1 to 577 nm SML or SL treatment. Retreatments were allowed. Rescue with intravitreal anti–vascular endothelial growth factor therapies or steroids was permitted if 10 or more ETDRS letter loss occurred, CRT increased > 400 μm, or both.Main Outcome MeasuresPrimary outcome was mean change in BCVA in the study eye at 24 months (noninferiority margin 5 ETDRS letters). Secondary outcomes were mean change from baseline to month 24 in binocular BCVA; CRT and mean deviation of Humphrey 10-2 visual field in the study eye; percentage meeting driving standards; EuroQoL EQ-5D-5L, 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), and Vision and Quality of Life Index (VisQoL) scores; cost per quality-adjusted life-years (QALYs) gained; adverse effects; and number of laser and rescue treatments.ResultsThe study recruited fully (n = 266); 87% of SML-treated and 86% of SL-treated patients had primary outcome data. Mean ± standard deviation BCVA change from baseline to month 24 was –2.43 ± 8.20 letters and –0.45 ± 6.72 letters in the SML and SL groups, respectively. Subthreshold micropulse laser therapy was deemed not only noninferior but also equivalent to SL therapy because the 95% confidence interval (CI; –3.9 to –0.04 letters) lay wholly within both upper and lower margins of the permitted maximum difference (5 ETDRS letters). No statistically significant difference was found in binocular BCVA (0.32 ETDRS letters; 95% CI, –0.99 to 1.64 ETDRS letters; P = 0.63); CRT (–0.64 μm; 95% CI, –14.25 to 12.98 μm; P = 0.93); mean deviation of the visual field (0.39 decibels (dB); 95% CI, –0.23 to 1.02 dB; P = 0.21); meeting driving standards (percentage point difference, 1.6%; 95% CI, –25.3% to 28.5%; P = 0.91); adverse effects (risk ratio, 0.28; 95% CI, 0.06–1.34; P = 0.11); rescue treatments (percentage point difference, –2.8%; 95% CI, –13.1% to 7.5%; P = 0.59); or EQ-5D, NEI-VFQ-25, or VisQoL scores. Number of laser treatments was higher in the SML group (0.48; 95% CI, 0.18–0.79; P = 0.002). Base-case analysis indicated no differences in costs or QALYs.ConclusionsSubthreshold micropulse laser therapy was equivalent to SL therapy, requiring slightly higher laser treatments.

Published
2023

9. Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: the DIAMONDS non-inferiority RCT: the DIAMONDS non-inferiority RCT

Author

Lois, Noemi, Campbell, Christina, Waugh, Norman, Azuara-Blanco, Augusto, Maredza, Mandy, Mistry, Hema, McAuley, Danny, Acharya, Nachiketa, Aslam, Tariq M, Bailey, Clare, Chong, Victor, Downey, Louise, Eleftheriadis, Haralabos, Fatum, Samia, George, Sheena, Ghanchi, Faruque, Groppe, Markus, Hamilton, Robin, Menon, Geeta, Saad, Ahmed, Sivaprasad, Sobha, Shiew, Marianne, Steel, David H, Talks, James Stephen, Doherty, Paul, McDowell, Clíona, and Clarke, Mike

Subjects
Adult, Macular Edema/surgery, SDG 3 - Good Health and Well-being, Lasers, Quality of Life, Diabetes Mellitus, Humans, Laser Coagulation/adverse effects, Diabetic Retinopathy/surgery, Ranibizumab/adverse effects, Endothelial Growth Factors/therapeutic use, Bevacizumab/adverse effects
Abstract

BackgroundThe National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of ObjectivesDetermining the clinical effectiveness, safety and cost-effectiveness of subthreshold micropulse laser compared with standard threshold macular laser to treat diabetic macular oedema with a central retinal subfield thickness of DesignA pragmatic, multicentre, allocation-concealed, double-masked, randomised, non-inferiority, clinical trial.SettingHospital eye services in the UK.ParticipantsAdults with diabetes and centre-involving diabetic macular oedema with a central retinal subfield thickness of 24 Early Treatment Diabetic Retinopathy Study letters (Snellen equivalent > 20/320) in one/both eyes.InterventionsParticipants were randomised 1 : 1 to receive 577 nm subthreshold micropulse laser or standard threshold macular laser (e.g. argon laser, frequency-doubled neodymium-doped yttrium aluminium garnet 532 nm laser); laser treatments could be repeated as needed. Rescue therapy with intravitreal anti-vascular endothelial growth factor therapies or steroids was allowed if a loss of ≥ 10 Early Treatment Diabetic Retinopathy Study letters between visits occurred and/or central retinal subfield thickness increased to > 400 µm.Main outcome measuresThe primary outcome was the mean change in best-corrected visual acuity in the study eye at 24 months (non-inferiority margin 5 Early Treatment Diabetic Retinopathy Study letters). Secondary outcomes included the mean change from baseline to 24 months in the following: binocular best-corrected visual acuity; central retinal subfield thickness; the mean deviation of the Humphrey 10–2 visual field in the study eye; the percentage of people meeting driving standards; and the EuroQol-5 Dimensions, five-level version, National Eye Institute Visual Function Questionnaire – 25 and Vision and Quality of Life Index scores. Other secondary outcomes were the cost per quality-adjusted life-years gained, adverse effects, number of laser treatments and additional rescue treatments.ResultsThe DIAMONDS trial recruited fully (n = 266); 87% of participants in the subthreshold micropulse laser group and 86% of participants in the standard threshold macular laser group had primary outcome data. Groups were balanced regarding baseline characteristics. Mean best-corrected visual acuity change in the study eye from baseline to month 24 was –2.43 letters (standard deviation 8.20 letters) in the subthreshold micropulse laser group and –0.45 letters (standard deviation 6.72 letters) in the standard threshold macular laser group. Subthreshold micropulse laser was deemed to be not only non-inferior but also equivalent to standard threshold macular laser as the 95% confidence interval (–3.9 to –0.04 letters) lay wholly within both the upper and lower margins of the permitted maximum difference (5 Early Treatment Diabetic Retinopathy Study letters). There was no statistically significant difference between groups in any of the secondary outcomes investigated with the exception of the number of laser treatments performed, which was slightly higher in the subthreshold micropulse laser group (mean difference 0.48, 95% confidence interval 0.18 to 0.79; p = 0.002). Base-case analysis indicated no significant difference in the cost per quality-adjusted life-years between groups.Future workA trial in people with ≥ 400 µm diabetic macular oedema comparing anti-vascular endothelial growth factor therapy alone with anti-vascular endothelial growth factor therapy and macular laser applied at the time when central retinal subfield thickness has decreased to LimitationsThe majority of participants enrolled had poorly controlled diabetes.ConclusionsSubthreshold micropulse laser was equivalent to standard threshold macular laser but required a slightly higher number of laser treatments.

Published
2022

10. Aflibercept in clinical practice; visual acuity, injection numbers and adherence to treatment, for diabetic macular oedema in 21 UK hospitals over 3 years

Author

Talks, S. J., Stratton, I., Peto, T., Lotery, A., Chakravarthy, U., Eleftheriadis, H., Izadi, S., Dhingra, N., Scanlon, Peter H, Talks, James, Mohamed, Quresh, Lotery, Andrew, Kashani, Sharam, Georgas, Nasos, Jones, Colin, Gashut, Abdisattar, Santiago, Cynthia, Chhabra, Romi, Antcliff, Richard, Dhingra, Naren, Bailey, Clare, Chakravarthy, Usha, Peto, Tunde, Ghanchi, Faruque, Mcinerney, Linda, Natha, Salim, Khan, Rehna, Dias, Indra, Mukhrejee, Raj, Izadi, Shahrnaz, Tahir, Irfan, and Eleftheriadis, Haralabos

Subjects
Vascular Endothelial Growth Factor A, medicine.medical_specialty, Scientific community, Visual acuity, Younger age, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, Real world evidence, Loading dose, Macular Edema, Article, 03 medical and health sciences, 0302 clinical medicine, Ranibizumab, Internal medicine, Diabetes Mellitus, medicine, Humans, 030212 general & internal medicine, Eye diseases, Aged, Retrospective Studies, Aflibercept, Diabetic Retinopathy, business.industry, Middle Aged, RA645.D54, Hospitals, United Kingdom, Clinical Practice, Ophthalmology, Receptors, Vascular Endothelial Growth Factor, Diabetic macular oedema, Intravitreal Injections, Cohort, 030221 ophthalmology & optometry, RE, medicine.symptom, business, medicine.drug
Abstract

Introduction Randomised controlled trials provide evidence that a treatment works. Real world evidence is required to assess if proven treatments are effective in practice. Method Retrospective data collection on patients given aflibercept for diabetic macular oedema over 3 years from 21 UK hospitals: visual acuity (VA); Index of multiple deprivation score (IMD); injection numbers; protocols used, compared as a cohort and between sites. Results Complete data: 1742 patients (from 2196 eligible) at 1 year, 860 (from 1270) at 2, 305 (from 506) at 3 years. The median VA improved from 65 to 71, 70, 70 (ETDRS letters) at 1, 2 and 3 years with 6, 9 and 12 injections, respectively. Loss to follow-up: 10% 1 year, 28.8% at 3. Centres varied: baseline: mean age 61–71 years (p p p p = 0.0023) and worse VA at baseline (p p = 0.0010). Conclusions The data showed significant variation between treatment centres for starting age, VA and IMD which influenced adherence and chances of good VA. Once treatment was started IMD did not alter likelihood of improvement. Loading dose intensity did not alter outcome at one year.

Published
2021

12. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials

Author

Heier, Jeffrey S, Lad, Eleonora M, Holz, Frank G, Rosenfeld, Philip J, Guymer, Robyn H, Boyer, David, Grossi, Federico, Baumal, Caroline R, Korobelnik, Jean-Francois, Slakter, Jason S, Waheed, Nadia K, Metlapally, Ravi, Pearce, Ian, Steinle, Nathan, Francone, Anibal A, Hu, Allen, Lally, David R, Deschatelets, Pascal, Francois, Cedric, Bliss, Caleb, Staurenghi, Giovanni, Monés, Jordi, Singh, Rishi P, Ribeiro, Ramiro, Wykoff, Charles C, Cole, Abosede O, Gerstenblith, Adam T, Kotagiri, Ajay, Edwards, Albert O, Zambrano, Alberto D, Eaton, Alexander M, Rubowitz, Alexander, Lyon, Alice T, Chiang, Allen, Ho, Allen, Hu, Allen Y, Guerami, Amir H, Dessouki, Amr L, de Carvalho, André Corrêa Maia, Emanuelli, Andrés, Chang, Andrew A, Antoszyk, Andrew N, Francone, Anibal Andrés, Prasad, Anita, Wolf, Armin, Khanani, Arshad M, Abbey, Ashkan Michael, Moulana, Asma, Wihelm, Barbara, Sikorski, Bartosz L, Kuppermann, Baruch D, Wolff, Benjamin, Jewart, Brian H, Do, Brian K, Chan-Kai, Brian T, Mein, Calvin, Hoyng, Carel B, Awh, Carl C, Regillio, Carl, Zeolite, Carlos, Baumal, Caroline R, Creuzot-Garcher, Catherine, Maury, Catherine Français, Wykoff, Charles C, Newell, Charles K, Jhaveri, Chirag, Lohmann, Chris P, Dinah, Christiana B, Ma, Colin, Crawford, Courtney, Parke, D Wilkin, Lavinsky, Daniel, Roth, Daniel, Pieramici, Dante J, Moshfeghi, Darius M, Levin, Darrin, Saperstein, David A, Brown, David, Gaucher, David, Lally, David R, Liao, David S, Brown, David Warren, Goldstein, Debra, Marcus, Dennis, Chan, Derek G, Dhoot, Dilsher, Tacite, Domingo, Zalewski, Dominik, Espana, Edgar M, Lad, Eleonora M, Souied, Eric H, Suan, Eric P, Eting, Eva, Sola, Federico Furno, de Bats, Flore, Bandello, Francesco, Gómez-Ulla, Francisco, Devin, François, Holz, Frank G, Chen, Fred K, Makkouk, Fuad, Dyer, Gawain, Spital, George, Staurenghi, Giovanni, Stoller, Glenn, Cousins, Gwen, Salehi-Had, Hani, Agostini, Hansjürgen, Eleftheriadis, Haralabos, Weiss, Harold, Sultan, Harris C, Massé, Hélène, Pearce, Ian, Dias, Indra, Barbazetto, Irene, Rosenblatt, Irit, Suñer, Ivan J, Kovach, Jaclyn L, Kaluzny, Jakub, Borthwick, James, Howard, James G, Wong, James, Ernest, Jan, Němčanský, Jan, Ysasaga, Jason Edward, Handza, Jason M, Moreno, Javier Antonio Montero, Korobelnik, Jean-François, Heier, Jeffrey S, Arnold, Jennifer J, Brown, Jeremiah, Bafalluy, Joaquin, Pearlman, Joel, Pitcher, John D, Kitchens, John, Carlson, John P, Gilhotra, Jolly, Fein, Jordana, Monés, Jordi M, Luna, José Domingo, Moreno, José María Ruiz, Coney, Joseph M, Sallum, Juliana Maria Ferraz, Olsen, Karl R, Blobner, Katharina, Macoul, Katherine A, Oh, Kean T, Malik, Khurram Javed, Hattenbach, Lars-Olof, Kodjikian, Laurent, Neto, Laurentino Biccas, Singerman, Lawrence J, Altay, Lebriz, Sheck, Leo-H, Feiner, Leonard, Harris, Lindsey D, Chishold, Lionel D, Rao, Llewelyn J, Nehemy, Márcio Bittar, Elizalde, Maria Jose Capella, Gamulescu, Maria-Andreea, Saravia, Mario J, Johnson, Mark W, McKibbin, Martin, Maccumber, Mathew, Vidosevich, Matko, Ohr, Matthew P, Samuel, Michael A, Singer, Michael A, Cassell, Michael, Dollin, Michael, Elman, Michael J, Ip, Michael S, Goldstein, Michaella, Busquets, Miguel, Mititelu, Mihai, Shah, Milan, Veith, Miroslav, Fineman, Mitchell, Varano, Monica, Christmas, Nancy, Steinle, Nathan C, Chaudhry, Nauman, Chinskey, Nicholas D, Eter, Nicole, London, Nikolas J S, Mathalone, Nurit, Schlottmann, Patricio G, Coady, Patrick, Higgins, Patrick M, Raskauskas, Paul A, Yates, Paul A, Bernstein, Paul, Mitchell, Paul, Monsour, Paul, Raphaelian, Paul V, Stanga, Paulo E, Stodulka, Pavel, Issa, Peter Charbel, Pavan, Peter, Ferrone, Phil J, Oleksy, Piotr, Abraham, Prema, Mruthyunjaya, Prithvi, Nguyen, Quan Dong, Reddy, Rahul K, Khurana, Rahul N, Tuli, Raman, Tadayoni, Ramin, Katz, Randy Steven, Arora, Rashi, Schlingemann, Reinier O, Rosen, Richard B, Gale, Richard, Scartozzi, Richard, Isernharge, Ricky, Singh, Rishi P, Stoltz, Robert A, Avery, Robert L, Wirthlin, Robert S, Guymer, Robyn, Goldberg, Roger A, Frenkel, Ronald, Belfort, Rubens Jr, Mohand-Said, Saddek, Grisanti, Salvatore, Razavi, Sam, Fraser-Bell, Samantha, Shah, Sandeep N, Wickremasinghe, Sanjeewa, Haug, Sara Joy, Adrean, Sean D, Priglinger, Siegfried G, Esposti, Simona Degli, Guest, Stephen, Huddleston, Stephen, Itty, Sujit, Moon, Suk Jin, Bhatia, Sumit P, Gupta, Sunil, Patel, Sunil S, Garg, Sunir J, Joshi, Sunir, Nghiem-Buffet, Sylvia, Johnson, T Mark, Jaouni, Tareq, Ach, Thomas, Williams, Thomas R, Sheidow, Thomas, Cleland, Timothy P, You, Timothy T, Peto, Tunde, Konidaris, Vasileios, Gonzalez, Victor H, Korda, Vladimir, Freeman, William R, Bridges, William Z, Barak, Yoreh, Zagorski, Zbigniew, Yehoshua, Zohar, and Dubska, Zora

Abstract

Geographic atrophy is a leading cause of progressive, irreversible vision loss. The objectives of OAKS and DERBY were to assess the efficacy and safety of pegcetacoplan compared with sham treatment in patients with geographic atrophy.

Published
2023
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13. Multicenter Evaluation of Diagnostic Circulating Biomarkers to Detect Sight-Threatening Diabetic Retinopathy

Author

Gurudas, Sarega, primary, Frudd, Karen, additional, Maheshwari, Jayapal Jeya, additional, Revathy, Yeddula Rebecca, additional, Sivaprasad, Sobha, additional, Ramanathan, Shruthi Mahalakshmi, additional, Pooleeswaran, Vignesh, additional, Prevost, A. Toby, additional, Karatsai, Eleni, additional, Halim, Sandra, additional, Chandra, Shruti, additional, Nderitu, Paul, additional, Conroy, Dolores, additional, Krishnakumar, Subramanian, additional, Parameswaran, Sowmya, additional, Dharmalingam, Kuppamuthu, additional, Ramasamy, Kim, additional, Raman, Rajiv, additional, Jones, Colin, additional, Eleftheriadis, Haralabos, additional, Greenwood, John, additional, and Turowski, Patric, additional

Published
2022
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14. Estimating excess visual loss from neovascular age-related macular degeneration in the UK during the COVID-19 pandemic: a retrospective clinical audit and simulation model

Author

Thomas, Darren S, primary, Warwick, Alasdair, additional, Olvera-Barrios, Abraham, additional, Egan, Catherine, additional, Schwartz, Roy, additional, Patra, Sudeshna, additional, Eleftheriadis, Haralabos, additional, Khawaja, Anthony, additional, Lotery, Andrew, additional, Muller, Philipp L, additional, Hamilton, Robin, additional, Preston, Ella, additional, Taylor, Paul, additional, and Tufail, Adnan, additional

Published
2022
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16. Reply

Author

Lois, Noemi, primary, Saad, Ahmed, additional, Vaideanu-Collins, Daniela, additional, Azuara-Blanco, Augusto, additional, Styles, Caroline, additional, McNally, Christine, additional, Jackson, Andrew, additional, Rice, Rachael, additional, Bailey, Clare, additional, McAuley, Danny, additional, Steel, David H., additional, Barbour, Clair, additional, Bell, Leontia, additional, Ghanchi, Faruque D., additional, Madanat, Zeid, additional, Menon, Geeta, additional, Chandran, Manju, additional, Mathews, Sely, additional, Galal, Mohammed, additional, Eleftheriadis, Haralabos, additional, Efraimidis, Stefanos, additional, Cook, Jonathan, additional, Wang, Ariel, additional, Sones, William, additional, Prior, Lindsay, additional, Acharya, Nachiketa, additional, Lois, Noemi, additional, Waugh, Norman, additional, Mistry, Hema, additional, Maredza, Mandy, additional, Fatum, Samia, additional, Savage, Janette, additional, Sivaprasad, Sobha, additional, Aldington, Stephen, additional, Scanlon, Peter H., additional, Ivanova, Katerina, additional, Aslam, Tariq M., additional, Ali, Zaria, additional, and Chong, Victor, additional

Published
2021
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17. Evaluation of a New Model of Care for People with Complications of Diabetic Retinopathy

Author

Lois, Noemi, primary, Cook, Jonathan A., additional, Wang, Ariel, additional, Aldington, Stephen, additional, Mistry, Hema, additional, Maredza, Mandy, additional, McAuley, Danny, additional, Aslam, Tariq, additional, Bailey, Clare, additional, Chong, Victor, additional, Ganchi, Faruque, additional, Scanlon, Peter, additional, Sivaprasad, Sobha, additional, Steel, David H., additional, Styles, Caroline, additional, Azuara-Blanco, Augusto, additional, Prior, Lindsay, additional, Waugh, Norman, additional, Saad, Ahmed, additional, Vaideanu-Collins, Daniela, additional, McNally, Christine, additional, Jackson, Andrew, additional, Rice, Rachael, additional, Barbour, Clair, additional, Bell, Leontia, additional, Ghanchi, Faruque D., additional, Madanat, Zeid, additional, Menon, Geeta, additional, Chandran, Manju, additional, Mathews, Sely, additional, Galal, Mohammed, additional, Eleftheriadis, Haralabos, additional, Efraimidis, Stefanos, additional, Cook, Jonathan, additional, Sones, William, additional, Acharya, Nachiketa, additional, Lois, Noemi, additional, Fatum, Samia, additional, Savage, Janette, additional, Scanlon, Peter H., additional, Ivanova, Katerina, additional, Aslam, Tariq M., additional, and Ali, Zaria, additional

Published
2021
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19. Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial

Author

Lotery, Andrew, primary, Sivaprasad, Sobha, additional, O'Connell, Abby, additional, Harris, Rosie A, additional, Culliford, Lucy, additional, Ellis, Lucy, additional, Cree, Angela, additional, Madhusudhan, Savita, additional, Behar-Cohen, Francine, additional, Chakravarthy, Usha, additional, Peto, Tunde, additional, Rogers, Chris A, additional, Reeves, Barnaby C, additional, Bellani, Samir, additional, Griffiths, Helen, additional, Thulasidharan, Suresh, additional, Watkins, Catrin, additional, Kaye, Rebecca, additional, Menon, Deepthy, additional, Neville, Qin, additional, Denham, Rebecca, additional, Gillvray, Karen, additional, Abugreen, Salwa, additional, Nixon, Natalie, additional, Alarbi, Mohammed, additional, Ghanchi, Faruque, additional, Madanat, Zeid, additional, Hawes, Nicola, additional, Hughes, Edward, additional, Keir, Campbell, additional, Kisza, Krystian, additional, Bailey, Clare, additional, Hazlewood, Phillippa, additional, Cloake, Julie, additional, Menon, Geeta, additional, Chandran, Manju, additional, Raguro, Abigail, additional, Mohamed, Moin, additional, Lim, Wei Sing, additional, Eleftheriadis, Haralabos, additional, Efraimidis, Stefanos, additional, McKibbin, Martin, additional, Mukherjee, Raj, additional, Wilson, Joanne, additional, Lenfestey, Pauline, additional, Harding, Simon, additional, Haigh, Kelly, additional, Chhabra, Ramandeep, additional, Horani, Mania, additional, Platt, Raisa-Marie, additional, Talks, James, additional, Bhatia, Devanga, additional, Andrews, Violet, additional, Downes, Susan, additional, Samuel, Ivy, additional, Buttress, Daniel, additional, Pagliarini, Sergio, additional, Randle, Linzi, additional, Allison, Jeanette, additional, Brand, Christopher, additional, Edwards, Maria, additional, Karia, Niral, additional, Shipman, Maria, additional, Thompson, Elridge, additional, Kotagiri, Ajay, additional, Steel, David, additional, Dodds, Steven, additional, Turner, Stephen, additional, Osoba, Yinka, additional, Criddle, Sharon, additional, Yang, Yit, additional, Narendran, Niro, additional, Karpoor, Meena, additional, Gale, Richard, additional, Airody, Archana, additional, and Grice-Holt, Alison, additional

Published
2020
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20. DIAbetic macular oedema aNd diode subthreshold micropulse laser (DIAMONDS) : Ppotocol for a randomised clinical trial

Author

Lois, Noemi, Gardner, Evie, Waugh, Norman, Azuara-Blanco, Augusto, Mistry, Hema, McAuley, Danny, Acharya, Nachiketa, Aslam, Tariq M., Bailey, Clare, Chong, Victor, Downey, Louise, Eleftheriadis, Haralabos, Fatum, Samia, George, Sheena, Ghanchi, Faruque, Groppe, Markus, Hamilton, Robin, Menon, Geeta, Saad, Ahmed, Sivaprasad, Sobha, Shiew, Marianne, Steel, David H., Talks, James Stephen, Adams, Catherine, Campbell, Christina, Mills, Matthew, Clarke, Mike, and HASH(0x5651c9f3bac8)

Subjects
genetic structures, RE
Abstract

Background\ud \ud In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST)

Published
2019

24. Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study

Author

Gale, Richard P, primary, Pearce, Ian, additional, Eter, Nicole, additional, Ghanchi, Faruque, additional, Holz, Frank G, additional, Schmitz-Valckenberg, Steffen, additional, Balaskas, Konstantinos, additional, Burton, Ben J L, additional, Downes, Susan M, additional, Eleftheriadis, Haralabos, additional, George, Sheena, additional, Gilmour, David, additional, Hamilton, Robin, additional, Lotery, Andrew J, additional, Patel, Nishal, additional, Prakash, Priya, additional, Santiago, Cynthia, additional, Thomas, Saju, additional, Varma, Deepali, additional, Walters, Gavin, additional, Williams, Michael, additional, Wolf, Armin, additional, Zakri, Rosina H, additional, Igwe, Franklin, additional, and Ayan, Filis, additional

Published
2019
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28. Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study.

Author

Gale, Richard P., Pearce, Ian, Eter, Nicole, Ghanchi, Faruque, Holz, Frank G., Schmitz-Valckenberg, Steffen, Balaskas, Konstantinos, Burton, Ben J. L., Downes, Susan M., Eleftheriadis, Haralabos, George, Sheena, Gilmour, David, Hamilton, Robin, Lotery, Andrew J., Patel, Nishal, Prakash, Priya, Santiago, Cynthia, Thomas, Saju, Varma, Deepali, and Walters, Gavin

Abstract

Background/Aims Prospective data on switching anti-vascular endothelial growth factors in patients with neovascular age-related macular degeneration (nAMD) who have previously shown no/partial response are limited. This prospective study assessed the effect of switching from aflibercept to ranibizumab on anatomical and functional outcomes in patients with persistent/recurrent disease activity. Methods SAFARI (NCT02161575) was a 6-month, prospective, single-arm study conducted in the UK and Germany. Patients, meeting strict eligibility criteria for one of two subgroups (primary treatment failure or suboptimal treatment response), received 3 monthly intravitreal ranibizumab injections (0.5 mg). Thereafter, ranibizumab was administered pro re nata at monthly visits. The primary endpoint was change from baseline (CfB) to day 90 in central subfield retinal thickness (CSRT). Best-corrected visual acuity (BCVA) and retinal morphology parameters were assessed. Results One hundred patients were enrolled (primary treatment failure, 1; suboptimal treatment response, 99). In the overall population, there was a significant CfB in median CSRT of -30.75 µm (95% CI -59.50,-20.50; p<0.0001) to day 90. Improvements were also observed in other quantitative and qualitative optical coherence tomography parameters. In Early Treatment Diabetic Retinopathy Study letters assessed by category, 55% and 59% of patients gained 0-≥15 letters versus baseline at day 90 and day 180, respectively. However, mean improvements in BCVA (CfB) to each time point were small (≤2 letters). No new safety signals were identified. Conclusion Switching from aflibercept to ranibizumab led to a significant improvement in CSRT, with ~60% experiencing stabilised/improved BCVA. Therefore, patients with nAMD who have shown a suboptimal response to aflibercept may benefit from switching to ranibizumab. [ABSTRACT FROM AUTHOR]

Published
2020
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29. United Kingdom Diabetic Retinopathy Electronic Medical Record (UK DR EMR) Users Group: report 4, real-world data on the impact of deprivation on the presentation of diabetic eye disease at hospital services

Author

Denniston, Alastair K, primary, Lee, Aaron Y, additional, Lee, Cecilia S, additional, Crabb, David P, additional, Bailey, Clare, additional, Lip, Peck-Lin, additional, Taylor, Paul, additional, Pikoula, Maria, additional, Cook, Esther, additional, Akerele, Toks, additional, Antcliff, Richard, additional, Brand, Christopher, additional, Chakravarthy, Usha, additional, Chavan, Randhir, additional, Dhingra, Narendra, additional, Downey, Louise, additional, Eleftheriadis, Haralabos, additional, Ghanchi, Faruque, additional, Khan, Rehna, additional, Kumar, Vineeth, additional, Lobo, Aires, additional, Lotery, Andrew, additional, Menon, Geeta, additional, Mukherjee, Rajarshi, additional, Palmer, Helen, additional, Patra, Sudeshna, additional, Paul, Bobby, additional, Sim, Dawn A, additional, Talks, James Stephen, additional, Wilkinson, Elizabeth, additional, Tufail, Adnan, additional, and Egan, Catherine A, additional

Published
2018
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30. Ranibizumab Plus Panretinal Photocoagulation versus Panretinal Photocoagulation Alone for High-Risk Proliferative Diabetic Retinopathy (PROTEUS Study)

Author

Figueira, João, primary, Fletcher, Emily, additional, Massin, Pascale, additional, Silva, Rufino, additional, Bandello, Francesco, additional, Midena, Edoardo, additional, Varano, Monica, additional, Sivaprasad, Sobha, additional, Eleftheriadis, Haralabos, additional, Menon, Geeta, additional, Amaro, Miguel, additional, Ayello Scheer, Sarah, additional, Creuzot-Garcher, Catherine, additional, Nascimento, João, additional, Alves, Dalila, additional, Nunes, Sandrina, additional, Lobo, Conceição, additional, and Cunha-Vaz, José, additional

Published
2018
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31. Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial

Author

Sivaprasad, Sobha, primary, Vasconcelos, Joana C, additional, Prevost, A Toby, additional, Holmes, Helen, additional, Hykin, Philip, additional, George, Sheena, additional, Murphy, Caroline, additional, Kelly, Joanna, additional, Arden, Geoffrey B, additional, Ahfat, Frank, additional, Bhatnagar, Ajay, additional, Narendran, Nirodhini, additional, Chavan, Randhir, additional, Cole, Abosede, additional, Crosby-Nwaobi, Roxanne, additional, Patrao, Namritha, additional, Menon, Deepthy, additional, Hogg, Chris, additional, Rubin, Gary, additional, Leitch-Devlin, Lauren, additional, Egan, Catherine, additional, Shah, Nisha, additional, Mansour, Tatiana, additional, Peto, Tunde, additional, Eleftheriadis, Haralabos, additional, Gibson, Joanathan, additional, Ghulakhszian, Arevik, additional, Vafidis, Gilli, additional, Hughes, Edward, additional, Jafree, Afsar, additional, Menon, Geeta, additional, Prakash, Priya, additional, Sandinha, Maria, additional, Smith, Richard, additional, Scanlon, Peter, additional, Chave, Steve, additional, Aldington, Steve, additional, Dale, Angela, additional, Hood, Gillian, additional, Hitman, Graham A, additional, Crabb, David, additional, Denniston, Alaistair, additional, Lewin, Douglas, additional, Grierson, Ian, additional, Walker, Sarah, additional, Sturt, Jackie, additional, and Sahu, Debendra, additional

Published
2018
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33. United Kingdom Diabetic Retinopathy Electronic Medical Record (UK DR EMR) Users Group: report 4, real-world data on the impact of deprivation on the presentation of diabetic eye disease at hospital services.

Author

Denniston, Alastair K., Lee, Aaron Y., Lee, Cecilia S., Crabb, David P., Bailey, Clare, Lip, Peck-Lin, Taylor, Paul, Pikoula, Maria, Cook, Esther, Akerele, Toks, Antcliff, Richard, Brand, Christopher, Chakravarthy, Usha, Chavan, Randhir, Dhingra, Narendra, Downey, Louise, Eleftheriadis, Haralabos, Ghanchi, Faruque, Khan, Rehna, and Kumar, Vineeth

Abstract

Aim To assess the impact of deprivation on diabetic retinopathy presentation and related treatment interventions, as observed within the UK hospital eye service. Methods This is a multicentre, national diabetic retinopathy database study with anonymised data extraction across 22 centres from an electronic medical record system. The following were the inclusion criteria: all patients with diabetes and a recorded, structured diabetic retinopathy grade. The minimum data set included, for baseline, age and Index of Multiple Deprivation, based on residential postcode; and for all time points, visual acuity, ETDRS grading of retinopathy and maculopathy, and interventions (laser, intravitreal therapies and surgery). The main outcome measures were (1) visual acuity and binocular visual state, and (2) presence of sight-threatening complications and need for early treatment. Results 79 775 patients met the inclusion criteria. Deprivation was associated with later presentation in patients with diabetic eye disease: the OR of being sightimpaired at entry into the hospital eye service (defined as 6/18 to better than 3/60 in the better seeing eye) was 1.29 (95% CI 1.20 to 1.39) for the most deprived decile vs 0.77 (95% CI 0.70 to 0.86) for the least deprived decile; the OR for being severely sight-impaired (3/60 or worse in the better seeing eye) was 1.17 (95% CI 0.90 to 1.55) for the most deprived decile vs 0.88 (95% CI 0.61 to 1.27) for the least deprived decile (reference=fifth decile in all cases). There is also variation in sight-threatening complications at presentation and treatment undertaken: the least deprived deciles had lower chance of having a tractional retinal detachment (OR=0.48 and 0.58 for deciles 9 and 10, 95% CI 0.24 to 0.90 and 0.29 to 1.09, respectively); in terms of accessing treatment, the rate of having a vitrectomy was lowest in the most deprived cohort (OR=0.34, 95% CI 0.19 to 0.58). Conclusions This large real-world study suggests that first presentation at a hospital eye clinic with visual loss or sight-threatening diabetic eye disease is associated with deprivation. These initial hospital visits represent the first opportunities to receive treatment and to formally engage with support services. Such patients are more likely to be sight-impaired or severely sight-impaired at presentation, and may need additional resources to engage with the hospital eye services over complex treatment schedules. [ABSTRACT FROM AUTHOR]

Published
2019
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34. Multimodal Imaging in a Case of Peripapillary Choroidal Neovascular Membrane Associated With Idiopathic Intracranial Hypertension.

Author

Igwe, Chinedu N., Nderitu, Paul, Eframidis, Stefanos, Eleftheriadis, Haralabos, and O’Sullivan, Eoin

Abstract

Optical coherence tomography angiography is one of the latest noninvasive imaging modalities for visualizing the vasculature of retina and choroid. We describe its application in the diagnosis, treatment, and monitoring of a patient with peripapillary choroidal neovascular membrane in the setting of idiopathic intracranial hypertension, who responded well to a course of ranibizumab intravitreal injections. [ABSTRACT FROM AUTHOR]

Published
2021
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35. Randomised trial of wide-field guided PRP for diabetic macular oedema treated with ranibizumab

Author

Talks, S. James, Bhatia, Devangna, Menon, Geeta, Cole, Abosede, Eleftheriadis, Haralabos, Downey, Louise, Chong, Ngai Victor, and Sivaprasad, Sobha

Abstract

Background: Diabetic macular oedema (DMO) is effectively treated with ranibizumab but multiple injections are required. Where there is also peripheral ischaemia, it has been promoted that targeted panretinal photocoagulation (PRP) may reduce the number of injections. Method: Patients with optical coherence tomography confirmed DMO and Ultra-widefield Fundus Fluorescein Angiography confirmed peripheral retinal ischaemia were randomised to PRP plus ranibizumab or ranibizumab monotherapy. After three injections, repeat injections were given until the visual acuity was stable and the macula was dry. Re-treatment was given if there was a drop of visual acuity and/or a recurrence of intra-retinal fluid. The primary outcome was the number of repeat injections required after the first 6 months up until 1 year. Results: There were 49 patients, 25 in the ranibizumab only group and 24 in the ranibizumab + PRP group recruited at seven UK sites. The average number of injections in the ranibizumab-only arm was 6.84 over 1 year and 2.52 between months 6 and 12. The average number of injections in the combined arm was 6.67, with the number of injections in the second 6 months 1.92. For the primary outcome, comparing the number of 6- to 12-month injections, the result was not statistically significant (p= 0.33). Conclusion: The addition of targeted PRP to areas of non-perfusion in a patient with DMO does not reduce the number of injections required in the first year. It seems most likely that local VEGF at the macula is the main cause of DMO.

Published
2019
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