Accès ouvert déclaré 2019 article

24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients

Earl Randy Craven, Thomas R. Walters, William C. Christie, Douglas G. Day, Richard Alan Lewis, Margot L. Goodkin, Michelle Chen, Veronica Wangsadipura, Michael R. Robinson, Marina Bejanian, Tin Aung, Allen Dale Beck, James D. Branch, Michael Coote, Charles J. Crane, Andrew C. S. Crichton, Steven James Day, F. Jane Durcan, Richard Evans, William J. Flynn, Sébastien Gagné, Damien F. Goldberg, Jack V. Greiner, Paul Jeppsen, Delan Jinapriya, C. Starck Johnson, Shimon Kurtz, Steven L. Mansberger, Joseph R. Martel, Shamira Perera, Michael H. Rotberg, Robert M. Saltzmann, Howard I. Schenker, Michael E. Tepedino, Maria Imelda R. Yap-Veloso, Harvey Siy Uy

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1Pays d’affiliation déclarés

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Le résumé fourni par la source

OBJECTIVE: The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG). METHODS: This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs). RESULTS: At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. CONCLUSIONS: Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364.

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: 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients
Date Crossref: 28/12/2019
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

Johns Hopkins University pays non établi dans la notice
Université ou école supérieure
Johns Hopkins Medicine pays non établi dans la notice
Établissement de santé
Endocrine Research Solutions (United States) pays non établi dans la notice
Entreprise
Minnesota Eye Consultants pays non établi dans la notice
Établissement de santé
Allergan (United States) pays non établi dans la notice
Entreprise
Ltd Keystone Research pays non établi dans la notice
Entreprise
Scott & Christie and Associates pays non établi dans la notice
Institution
Coastal Research Associates pays non établi dans la notice
Institution
Sacramento Eye Consultants pays non établi dans la notice
Institution
Allergan plc pays non établi dans la notice
Institution

Johns Hopkins University, Johns Hopkins Medicine et Endocrine Research Solutions (United States), avec 7 autres affiliations.

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

Les sujets associés

Glaucoma and retinal disordersCorneal surgery and disordersRetinal Diseases and Treatments

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