Accès ouvert déclaré 2021 article

Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)

Jason Bacharach, Andrew J. Tatham, Gloria E. Ferguson, Sandra Belalcázar, Hagen Thieme, Margot L. Goodkin, Michelle Y. Chen, Qiang Guo, Jeen Liu, Michael R. Robinson, Marina Bejanian, David Wirta, Arturo Alezzandrini, Gabriel Bercovich, Pablo Deromedis, Federico Furno Sola, Carolina Gentile, Simon Fabian Lerner, Anahi Lupinacci, Carlos Zeolite, Catherine M. Birt, Andrew C. S. Crichton, Sébastien Gagné, Michael Giunta, Paul J. Harasymowycz, Delan Jinapriya, Marcelo Teixeira Nicolela, Donald R. Nixon, Patrick Saurel, David F. Yan, Darana Yuen, Santiago Arango, Alexander Martínez, Juan Camilo Restrepo, Vladimír Korda, Jana Kadlecová, Jitka Svačinová, Hany Ahmed Khairy, Hani El Ibiary, Zeinab El Sanabary, Katharina Cornelia Bell, Roman Greslechner, Joerg Michael Koch, Katrin Lorenz, Isabel Oberacher-Velten, Stefanie Schmickler, C Schuart, Francesco Maria Bandello, Carlo Cagini, Michele Figus, Leonardo Mastropasqua, Luca Mario Rossetti, Maurizio Giacinto Uva, Sandragasu Thayanithi, Anthony P. Wells, Rahat Husain, Victor Koh, Dawn Ka-Ann Lim, Tin Aung, Petrus Gous, Lynette Venter, Changwon Kee, Michael S. Kook, Muhsin Eraslan, Ozcan Rasim KAYIKCIOGLU, Nilgün Yıldırım, Rupert Bourne, Anshoo Choudhary, Maria Francesca Cordeiro, Vincent Dubois, James Kirwan, Sheng Yang Lim, Keith R G Martin, Antony Nithy, Avinash V Prabhu, Ahmad Amir, Howard S. Barnebey, Allen Dale Beck, Lance Bergstrom, Navaneet S.C. Borisuth, James D. Branch, Jonathan Briggs, Stephen Bylsma, Peter T. S. Chang, William C. Christie, Frank Cotter, Michael Depenbusch, Damien F. Goldberg, Jack V. Greiner, SHAILESH KUMAR GUPTA, Ron Gutmark, Ying Han, Sebastian B. Heersink, Malik Y. Kahook, Albert S Khouri, Joshua Kim, Howard Kushnick, Christopher Lin, Jodi Luchs, Arindel S.R. Maharaj, Steven L. Mansberger, Frank Mares, Eydie G. Miller-Ellis, Satish S. Modi, Matthew D. Paul, Ian Pitha, Robert M. Saltzmann, Michelle A. Sato, Michael Savestsky, Bruce Segal, Zachary Segal, Janet B. Serle, Mark B. Sherwood, Inder Paul Singh, Stephen E. P. Smith, Julia Song, Robert C. Sorenson, Lawrence R. Tenkman, Navin H Tekwani, Carl B. Tubbs, Farrell C. Tyson, Gianmarco Vizzeri, Steven D. Vold, Qui Vu, Kimberly S. Warren

75Citations signalées, ce qui n’est pas une note de qualité

6Institutions déclarées

4Pays d’affiliation déclarés

Rattachement africain : us, gb, co, de. Niveau de preuve : code pays fourni par la source.

Le résumé fourni par la source

OBJECTIVE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). RESULTS: Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2-7.4, 6.5-7.8, and 6.1-6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. CONCLUSIONS: The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma. CLINICALTRIALS. GOV IDENTIFIER: NCT02250651.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.

Le contrôle bibliographique ouvert

DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.

Titre Crossref: Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)
Date Crossref: 01/11/2021
Éditeur: Springer Science and Business Media LLC
Type: journal-article

Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.

Où se fait cette recherche

Bay Medical Center pays non établi dans la notice
Établissement de santé
University of Edinburgh pays non établi dans la notice
Université ou école supérieure
Fundación Neumológica Colombiana pays non établi dans la notice
Organisation à but non lucratif
University Hospital Magdeburg pays non établi dans la notice
Établissement de santé
AbbVie (United States) pays non établi dans la notice
Entreprise
Allergan (United States) pays non établi dans la notice
Entreprise
North Bay Eye Associates pays non établi dans la notice
Institution
Grupo Laser Vision pays non établi dans la notice
Institution
Fundación Oftalmológica Nacional pays non établi dans la notice
Institution
University Eye Clinic Magdeburg pays non établi dans la notice
Université ou école supérieure
an AbbVie company Allergan pays non établi dans la notice
Entreprise
Aesthetic Eye Care Institute and Eye Research Foundation pays non établi dans la notice
Structure de recherche

Bay Medical Center, University of Edinburgh et Fundación Neumológica Colombiana, avec 9 autres affiliations.

Une affiliation ne permet pas de déduire la nationalité d’un auteur.

Les sujets associés

Corneal surgery and disordersGlaucoma and retinal disordersOcular Surface and Contact Lens

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