| Title: |
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 ; Lancet |
| Authors: |
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; MONES, 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; CREUZOT-GARCHER, Catherine; MAURY, Catherine Français; 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; LIAO, David S.; BROWN, David Warren; GOLDSTEIN, Debra; MARCUS, Dennis; CHAN, Derek G.; DHOOT, Dilsher; TACITE, Domingo; ZALEWSKI, Dominik; ESPANA, Edgar M.; SOUIED, Eric H.; SUAN, Eric P.; ETING, Eva; SOLA, Federico Furno; DE BATS, Flore; BANDELLO, Francesco; GÓMEZ-ULLA, Francisco; DEVIN, François; CHEN, Fred K.; MAKKOUK, Fuad; DYER, Gawain; SPITAL, George; STOLLER, Glenn; COUSINS, Gwen; SALEHI-HAD, Hani; AGOSTINI, Hansjürgen; ELEFTHERIADIS, Haralabos; WEISS, Harold; SULTAN, Harris C.; MASSÉ, Hélène; 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; 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; 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 |
| Publication Year: |
2023 |
| Subject Terms: |
Sciences du Vivant [q-bio]/Santé publique et épidémiologie |
| Description: |
BACKGROUND: 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. METHODS: OAKS and DERBY were two 24-month, multicentre, randomised, double-masked, sham-controlled, phase 3 studies, in which patients aged 60 years and older with geographic atrophy secondary to age-related macular degeneration were enrolled at 110 clinical sites and 122 clinical sites worldwide, respectively. Patients were randomly assigned (2:2:1:1) by central web-based randomisation system to intravitreal 15 mg per 0·1 mL pegcetacoplan monthly or every other month, or sham monthly or every other month using stratified permuted block randomisation (stratified by geographic atrophy lesion area at screening, history or presence of active choroidal neovascularisation in the eye not under assessment, and block size of six). Study site staff, patients, reading centre personnel, evaluating physicians, and the funder were masked to group assignment. Sham groups were pooled for the analyses. The primary endpoint was the change from baseline to month 12 in the total area of geographic atrophy lesions in the study eye based on fundus autofluorescence imaging, in the modified intention-to-treat population (ie, all patients who received one or more injections of pegcetacoplan or sham and had a baseline and at least one post-baseline value of lesion area). Key secondary endpoints (measured at 24 months) were change in monocular maximum reading speed of the study eye, change from baseline in mean functional reading independence index score, change from baseline in normal luminance best-corrected visual acuity score, and change from baseline in the mean threshold sensitivity of all points in the study eye by mesopic microperimetry (OAKS only). Safety analyses included patients who were randomly assigned and received at least one injection of pegcetacoplan or sham. The now completed ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1016/S0140-6736(23)01520-9 |
| Availability: |
https://oskar-bordeaux.fr/handle/20.500.12278/186542; https://hdl.handle.net/20.500.12278/186542; https://doi.org/10.1016/S0140-6736(23)01520-9 |
| Rights: |
open ; Pas de Licence CC |
| Accession Number: |
edsbas.9B787373 |
| Database: |
BASE |