Cargando…

Phase 1 Dose-Escalation Study of Plasma Kallikrein Inhibitor THR-149 for the Treatment of Diabetic Macular Edema

PURPOSE: The purpose of this study was to evaluate the safety and preliminary efficacy of a single intravitreal injection of 3 dose levels of THR-149 in adults with center-involved diabetic macular edema (DME). METHODS: A phase 1, open-label, multicenter 3 + 3 dose-esclation study with 3-month follo...

Descripción completa

Detalles Bibliográficos
Autores principales:	Dugel, Pravin U., Khanani, Arshad M., Berger, Brian B., Patel, Sunil, Fineman, Mitchell, Jaffe, Glenn J., Kozma-Wiebe, Petra, Heier, Jeffrey
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	The Association for Research in Vision and Ophthalmology 2021
Materias:	Clinical Trials
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8711005/ https://www.ncbi.nlm.nih.gov/pubmed/34940810 http://dx.doi.org/10.1167/tvst.10.14.28

Ejemplares similares

Phase 1 Study of THR-687, a Novel, Highly Potent Integrin Antagonist for the Treatment of Diabetic Macular Edema
por: Khanani, Arshad M., et al.
Publicado: (2021)

Dexamethasone intravitreal implant in the treatment of diabetic macular edema
por: Dugel, Pravin U, et al.
Publicado: (2015)

Retrospective Study of Ellipsoid Zone Integrity Following Treatment with Intravitreal Ocriplasmin (OZONE Study)
por: Drenser, Kimberly A, et al.
Publicado: (2021)

Targeting Plasma Kallikrein With a Novel Bicyclic Peptide Inhibitor (THR-149) Reduces Retinal Thickening in a Diabetic Rat Model
por: Van Bergen, Tine, et al.
Publicado: (2021)

Conversion of Central Subfield Thickness Measurements of Diabetic Macular Edema Across Cirrus and Spectralis Optical Coherence Tomography Instruments
por: Sun, Jennifer K., et al.
Publicado: (2021)

Treatment of Diabetic Macular Edema with Aflibercept and Micropulse Laser (DAM Study)
por: Koushan, Keyvan, et al.
Publicado: (2022)

Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial
por: Khanani, Arshad M., et al.
Publicado: (2020)

CLINICAL EVIDENCE OF THE MULTIFACTORIAL NATURE OF DIABETIC MACULAR EDEMA
por: Chakravarthy, Usha, et al.
Publicado: (2018)

Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial
por: Patel, Sunil S., et al.
Publicado: (2023)

Functional Analysis of the Ser149/Thr149 Variants of Human Aspartylglucosaminidase and Optimization of the Coding Sequence for Protein Production
por: Banning, Antje, et al.
Publicado: (2017)

Correction: Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial
por: Patel, Sunil S., et al.
Publicado: (2023)

Impact of Modifying Abicipar Manufacturing Process in Patients with Neovascular Age-Related Macular Degeneration: MAPLE Study Results
por: Callanan, David, et al.
Publicado: (2023)

Updates on the Clinical Trials in Diabetic Macular Edema
por: Demirel, Sibel, et al.
Publicado: (2016)

Comorbidity and health care visit burden in working-age commercially insured patients with diabetic macular edema
por: Kiss, Szilárd, et al.
Publicado: (2016)

Intravitreal ziv-aflibercept for macular edema following retinal vein occlusion
por: Paulose, Remya, et al.
Publicado: (2016)

Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2)
por: Jumper, J Michael, et al.
Publicado: (2018)

Bradykinin 1 Receptor Antagonist BI1026706 Does Not Reduce Central Retinal Thickness in Center-Involved Diabetic Macular Edema
por: Lang, Gabriele E., et al.
Publicado: (2020)

PATIENT-REPORTED VISUAL FUNCTION FROM THE OCRIPLASMIN FOR TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION, INCLUDING MACULAR HOLE (OASIS) STUDY
por: Mein, Calvin, et al.
Publicado: (2020)

Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1)
por: Blinder, Kevin J, et al.
Publicado: (2017)

Endophthalmitis rates among patients receiving intravitreal anti-VEGF injections: a USA claims analysis
por: Kiss, Szilárd, et al.
Publicado: (2018)

Impact of Prophylactic Ranibizumab to Prevent Neovascular Age-Related Macular Degeneration on Eyes With Intermediate Age-Related Macular Degeneration
por: Chan, Clement K., et al.
Publicado: (2023)

Systemic exposure following intravitreal administration of therapeutic agents: an integrated pharmacokinetic approach. 1. THR-149
por: Vanhove, Marc, et al.
Publicado: (2021)

Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region
por: Wei, Wenbin, et al.
Publicado: (2021)

Cooling Anesthesia for Intravitreal Injection: Results of the Prospective Open-Label, Dose-Ranging COOL-1 Trial
por: Chao, Daniel L, et al.
Publicado: (2021)

Baseline visual acuity strongly predicts visual acuity gain in patients with diabetic macular edema following anti-vascular endothelial growth factor treatment across trials
por: Dugel, Pravin U, et al.
Publicado: (2016)

Clinical experience with fixed bimonthly aflibercept dosing in treatment-experienced patients with neovascular age-related macular degeneration
por: Khanani, Arshad M
Publicado: (2015)

Pars Plana Vitrectomy with Internal Limiting Membrane Peeling for Treatment-Naïve Diabetic Macular Edema: A Prospective, Uncontrolled Pilot Study
por: Rush, Ryan B, et al.
Publicado: (2021)

Topical administration of regorafenib eye drops: phase I dose‐escalation study in healthy volunteers
por: Zimmermann, Torsten, et al.
Publicado: (2018)

De-escalation of axillary surgery in breast cancer patients treated in the neoadjuvant setting: a Dutch population-based study
por: Simons, J. M., et al.
Publicado: (2020)

Efficacy and safety of sustained-delivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study
por: Massin, Pascale, et al.
Publicado: (2016)

When is macular edema not macular edema? An update on macular telangiectasia type 2
por: Wu, Lihteh
Publicado: (2015)

Safety and Tolerability of Intravitreal Carotuximab (DE-122) in Patients With Persistent Exudative Age-Related Macular Degeneration: A Phase I Study
por: Gonzalez, Victor H., et al.
Publicado: (2021)

Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study
por: Singer, Michael A, et al.
Publicado: (2015)

Two or more dexamethasone intravitreal implants in treatment-naïve patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study
por: Dugel, Pravin U., et al.
Publicado: (2015)

Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy
por: Singh, Rishi, et al.
Publicado: (2012)

THE OASIS MP-1 SUBSTUDY: Characterization of the Effect of Ocriplasmin on Microperimetry Parameters
por: Sadda, SriniVas R., et al.
Publicado: (2019)

CYP2D6 genotype- and endoxifen-guided tamoxifen dose escalation increases endoxifen serum concentrations without increasing side effects
por: Dezentjé, V. O., et al.
Publicado: (2015)

2207: A Phase I dose escalation trial of nab-paclitaxel and fixed dose radiation in patients with unresectable or borderline resectable pancreatic cancer
por: Ezra Shabason, Jacob, et al.
Publicado: (2018)

Phase I Dose‐Escalation Study of Ramucirumab in Chinese Patients with Advanced Solid Tumors
por: Cao, Junning, et al.
Publicado: (2017)

A phase II, multicentre trial evaluating the efficacy of de-escalated bisphosphonate therapy in metastatic breast cancer patients at low-risk of skeletal-related events
por: Addison, Christina L., et al.
Publicado: (2014)

Cannot write session to /tmp/vufind_sessions/sess_ghgqh7e1k4r642l1ihlaqkv8d9