Purpose: To evaluate the safety and efficacy of dexamethasone phosphate ophthalmic solution (EGP-437) delivered by a transscleral iontophoresis delivery system (EyeGate II) compared to that of topical prednisolone acetate 1% (PA 1%) in subjects with noninfectious anterior uveitis.
Design: Prospective, randomized, double-masked, parallel group, noninferiority clinical trial.
Methods: A total of 193 subjects with active noninfectious anterior uveitis (anterior chamber [AC] cell count ≥11 cells) were randomized to EGP-437 delivered by iontophoresis (days 0 and 7) or self-administered PA 1% daily (tapered schedule, days 0-28). Masking was maintained with placebo iontophoresis or eye drops. The primary efficacy endpoint was the proportion of subjects with an AC cell count of zero on day 14. Noninferiority of EGP-437 was defined if the lower limit of the confidence interval (CI) for the difference (EGP-437 minus PA 1%) was less than -10%.
Results: At day 14, 32 of 96 EGP-437 subjects (33.3%) and 32 of 97 PA 1% subjects (33.0%) had an AC cell count of zero (difference, 0.34; 95% CI, -12.94 to 13.63; P = 0.064). Efficacy trended better with EGP-437 among patients with more severe baseline uveitis (AC cell count >25). Safety and tolerability were good with both treatments. EGP-437 subjects experienced fewer IOP elevations ≥6 mm Hg versus PA 1% subjects (13 vs 24 incidents, respectively, through day 28).
Conclusions: Despite clinically similar response rates, statistical noninferiority of EGP-437 versus a tapered regimen of PA 1% was not achieved. Numerical trends suggesting fewer IOP elevations with EGP-437, similar efficacy overall, and possibly better efficacy in more severe disease warrant further study.
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http://dx.doi.org/10.1016/j.ajo.2019.10.032 | DOI Listing |
PLoS One
January 2025
Department of Microbiology, Mbarara University of Science and Technology, Uganda.
Background: Antiretroviral therapy (ART) restores cellular immunity, significantly reducing AIDS-related mortality and morbidity thus improving the quality of life among People living with HIV (PLHIV). Studies done in several countries show a decline in AIDS defining cancers (ADCs) with the introduction of ART however the increased longevity has led to the increase of Non-AIDS defining cancers (NADCs). The study was aimed at studying the changing spectrum and trends of cancer among Human Immunodeficiency Virus (HIV) patients in southwestern Uganda.
View Article and Find Full Text PDFJ Gastrointest Cancer
January 2025
Department of Gastroenterological Surgery, Toho University Medical Center Omori Hospital, 6-11-1 Omori-nishi, Ota-ku, Tokyo, 142-8541, Japan.
Purpose: Basophils play a crucial role in immunoglobulin E-mediated allergic reactions and parasitic infections. Recently, a low basophil count was reported to be a poor prognostic indicator in patients with malignant tumors. This study aimed to investigate the cut-off value to evaluate the clinicopathological and prognostic significance of the basophil count in patients with gastric cancer.
View Article and Find Full Text PDFCurr Protoc
January 2025
Department of Microbiology, University of Manitoba, Winnipeg, Manitoba, Canada.
Competitive fitness is a fundamental concept in evolutionary biology that captures the ability of organisms to survive, reproduce, and compete for resources in their environment. Competitive fitness is typically assessed in the lab by growing two or more competitors together and measuring the frequency of each at multiple time points. Traditional microbial competitive fitness assays are labor intensive and involve plating on solid medium and counting colonies.
View Article and Find Full Text PDFJ Med Virol
February 2025
Infectious Diseases Department, University Hospital Montpellier & INSERM U1175, University Montpellier, Montpellier, France.
Despite viral suppression with antiretroviral therapy, immune nonresponders (INR) among people living with HIV (PLWH) still have a higher risk of developing AIDS-related and non-AIDS-related complications. Our study aimed to investigate the phenotype and functions of Natural Killer (NK) cells in INR, to better understand underlying mechanisms of immune nonresponse. Our cross-sectional study included PLWH aged over 45 with an undetectable HIV viral load sustained for at least 2 years.
View Article and Find Full Text PDFGlobal Spine J
January 2025
Department of Orthopedic Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.
Study Design: Retrospective study.
Objective: To elucidate the factors influencing the identification of causative microorganisms in vertebral osteomyelitis (VO) and the effectiveness of different culture methods in increasing the identification rate.
Methods: A total of 252 patients diagnosed with and treated for VO at a single hospital were enrolled.
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