Purpose: To compare fundus autofluorescence (FAF) and spectral domain optical coherence tomography (OCT) measurements of geographic atrophy (GA) area and to analyze lesion area changes measured by spectral domain OCT in GATHER1.
Design: An assessment reliability analysis using prospective, randomized, double-masked phase 2/3 clinical trial data.
Methods: GATHER1 examined the efficacy and safety of avacincaptad pegol (ACP) for GA treatment. A post hoc analysis was performed to identify correlations between FAF- and OCT-based measurements of GA. GA area was measured on blue-light FAF images using semiautomatic segmentation software with support from OCT and near-infrared imaging. Machine-learning enhanced, multilayer segmentation of OCT scans were reviewed by human readers, and segmentation errors were corrected as needed. GA area was defined as total RPE loss on cross-sectional B scans. Time points included Months 0, 6, 12, and 18. Additionally, OCT-based GA-area changes between ACP and sham were analyzed.
Results: There was a strong correlation (r = 0.93) between FAF and OCT GA area measurements that persisted through 18 months. Mean (SD) differences between OCT and FAF GA measurements were negligible: 0.11 mm (1.42) at Month 0, 0.03 mm (1.62) at Month 6, -0.17 mm (1.81) at Month 12, and -0.07 mm (1.78) at Month 18. OCT assessments of GA growth revealed a 30% and 27% reduction at Months 12 and 18, respectively, between ACP and sham, replicating FAF measurements from GATHER1.
Conclusions: The strong correlation between blue FAF and OCT measurements of GA area supports OCT as a reliable method to measure GA lesion area in clinical trials.
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http://dx.doi.org/10.1016/j.ajo.2024.04.031 | DOI Listing |
Value Health
October 2024
Health Intervention and Technology Assessment Program (HITAP), Ministry of Public Health, Nonthaburi, Thailand; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.
Objectives: Health technology assessment (HTA) guidelines are intended to support successful implementation of HTA by enhancing consistency and transparency in concepts, methods, process, and use, thereby enhancing the legitimacy of the decision-making process. This report lays out good practices and practical recommendations for developing or updating HTA guidelines to ensure successful implementation.
Methods: The task force was established in 2022 and comprised experts and academics from various geographical regions, each with substantial experience in developing HTA guidelines for national health policymaking.
Pharmaceuticals (Basel)
December 2024
Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.
Background/objectives: Pasireotide (PAS) is a somatostatin receptor ligand (SRL) used to treat acromegaly, a chronic condition caused by excess growth hormone. While it offers significant benefits as a second-line treatment for uncontrolled acromegaly, its use raises major concerns due to hyperglycemic side effects and gastrointestinal issues, the latter being similar to those seen with first-generation SRLs. The aim of this study is to evaluate the real-world evidence on adverse drug reactions (ADRs) reported for PAS in the EudraVigilance database, in comparison to other established drug-based therapies for acromegaly.
View Article and Find Full Text PDFPharmaceuticals (Basel)
November 2024
School of Basic Pharmaceutical and Toxicological Sciences, College of Pharmacy, University of Louisiana Monroe, Monroe, LA 71201, USA.
: Endothelial hyperpermeability is the hallmark of severe disease, including sepsis and acute respiratory syndrome (ARDS). The development of medical countermeasures to treat the corresponding illness is of utmost importance. Synthetic somatostatin analogs (SSA) are FDA-approved drugs prescribed in patients with neuroendocrine tumors, and they act via growth hormone (GH) suppression.
View Article and Find Full Text PDFInt J Mol Sci
December 2024
Leibniz-Institute of Photonic Technology (Leibniz-IPHT), Albert-Einstein-Str. 9, 07745 Jena, Germany.
Colorectal cancer is one of the most prevalent forms of cancer globally. The most common routine diagnostic methods are the examination of the interior of the colon during colonoscopy or sigmoidoscopy, which frequently includes the removal of a biopsy sample. Optical methods, such as Raman spectroscopy (RS) and optical coherence tomography (OCT), can help to improve diagnostics and reduce the number of unnecessary biopsies.
View Article and Find Full Text PDFMedicina (Kaunas)
December 2024
Ophthalmology Laboratory, Neuroscience Institute, Lithuanian University of Health Sciences, Medical Academy, Eiveniu 2, LT-50161 Kaunas, Lithuania.
: Age-related macular degeneration (AMD) is the leading cause of blindness, affecting millions worldwide. Its pathogenesis involves the death of the retinal pigment epithelium (RPE), followed by photoreceptor degeneration. Although AMD is multifactorial, various genetic markers are strongly associated with the disease and may serve as biomarkers for evaluating treatment efficacy.
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