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Yina Kuang - One of the best experts on this subject based on the ideXlab platform.
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phase 1 clinical study to assess the safety of a novel drug delivery system providing long term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
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Phase 1 clinical study to assess the safety of a novel drug delivery system providing long‐term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
Richard G. Douglas - One of the best experts on this subject based on the ideXlab platform.
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phase 1 clinical study to assess the safety of a novel drug delivery system providing long term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
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Phase 1 clinical study to assess the safety of a novel drug delivery system providing long‐term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
Claus Cursiefen - One of the best experts on this subject based on the ideXlab platform.
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intensified Topical Steroids as prophylaxis for macular edema after posterior lamellar keratoplasty combined with cataract surgery
American Journal of Ophthalmology, 2016Co-Authors: Robert Hoerster, Tisha Prabriputaloong Stanzel, Bjoern O Bachmann, Sebastian Siebelmann, Moritz Felsch, Claus CursiefenAbstract:Purpose To analyze the effect of intensified Topical Steroid therapy after Descemet membrane endothelial keratoplasty combined with cataract surgery (triple-DMEK) on the incidence of postoperative cystoid macular edema (CME). Design Single-center comparative clinical study with historical controls. Methods Setting: Department of Ophthalmology, University of Cologne, Germany, tertiary hospital, performing 500 corneal transplant surgeries per year. Patients: Total of 131 patients (150 eyes) undergoing triple-DMEK surgery. Inclusion Criterion: Triple-DMEK surgery. Exclusion Criteria: Prior retinal surgery, history of prior CME. Interventions: Prednisolone acetate eye drops 1% 5 times daily for the first week after surgery. After an internal change of therapy regimen: Prednisolone acetate eye drops 1% hourly for the first postoperative week. We compared 75 consecutive eyes before with 75 consecutive eyes after the change of therapy regimen. Patients received macular spectral-domain optical coherence tomography (SD OCT) preoperatively, as well as 6 weeks and 3 and 6 months post surgery. Main Outcome Measure: Development of CME detected by macular SD OCT during 6 months postoperatively. Results Both groups were comparable regarding baseline age, sex, central corneal thickness, rebubbling rate, and visual acuity. With Topical Steroid therapy 5 times per day during the first postoperative week, we observed 9 cases of subsequent CME (12%). With hourly Topical Steroid therapy none of the patients developed CME subsequently ( P = .003). Apart from the Topical Steroids during the first week, medical treatment was identical in both groups. Conclusions Early intensified postoperative Topical Steroid therapy constitutes an effective prophylactic treatment to reduce incidence of CME after triple-DMEK surgery.
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long term Topical Steroid treatment improves graft survival following normal risk penetrating keratoplasty
American Journal of Ophthalmology, 2007Co-Authors: Nhung X. Nguyen, Berthold Seitz, Peter Martus, Achim Langenbucher, Claus CursiefenAbstract:Purpose To assess the impact of duration of Topical Steroid treatment on the incidence of endothelial graft rejection after normal-risk penetrating keratoplasty (PK). Design Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age 52 ± 19 years; follow-up 42 ± 18 months). Methods Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first six months. Patients were then randomized into either short-term (stop Topical Steroid treatment) or long-term treatment (continue Steroids once daily for 12 months). Results During follow-up, 29 eyes (7.1%) developed an episode of endothelial graft rejection. Graft rejections were significantly more common in the short-term (19 of 202; 9.1%) compared with the long-term treatment group (10 of 204: 4.9%; P = .001). Conclusions Long-term, low-dose Topical Steroid treatment protects against immunologic graft rejections.
Alkis J Psaltis - One of the best experts on this subject based on the ideXlab platform.
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phase 1 clinical study to assess the safety of a novel drug delivery system providing long term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
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Phase 1 clinical study to assess the safety of a novel drug delivery system providing long‐term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
Joanne Rimmer - One of the best experts on this subject based on the ideXlab platform.
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phase 1 clinical study to assess the safety of a novel drug delivery system providing long term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
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Phase 1 clinical study to assess the safety of a novel drug delivery system providing long‐term Topical Steroid therapy for chronic rhinosinusitis
International Forum of Allergy & Rhinology, 2019Co-Authors: Richard G. Douglas, Tom Kuruvilla, Anders Cervin, Joanne Rimmer, Alkis J Psaltis, Yina KuangAbstract:Background: Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous Topical Steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces. Methods: A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and Topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores. Results: LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05). Conclusion: LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.
