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Abstract #107446 Published in IGR 23-4
Endpoints for clinical trials in ophthalmology
Schmetterer L; Scholl H; Garhöfer G; Janeschitz-Kriegl L; Corvi F; Sadda SR; Medeiros FAProgress in Retinal and Eye Research 2023; 0: 101160
With the identification of novel targets, the number of interventional clinical trials in ophthalmology has increased. Visual acuity has for a long time been considered the gold standard endpoint for clinical trials, but in the recent years it became evident that other endpoints are required for many indications including geographic atrophy and inherited retinal disease. In glaucoma the currently available drugs were approved based on their IOP lowering capacity. Some recent findings do, however, indicate that at the same level of IOP reduction, not all drugs have the same effect on visual field progression. For neuroprotection trials in glaucoma, novel surrogate endpoints are required, which may either include functional or structural parameters or a combination of both. A number of potential surrogate endpoints for ophthalmology clinical trials have been identified, but their validation is complicated and requires solid scientific evidence. In this article we summarize candidates for clinical endpoints in ophthalmology with a focus on retinal disease and glaucoma. Functional and structural biomarkers, as well as quality of life measures are discussed, and their potential to serve as endpoints in pivotal trials is critically evaluated.
Singapore Eye Research Institute, Singapore; SERI-NTU Advanced Ocular Engineering (STANCE), Singapore; Academic Clinical Program, Duke-NUS Medical School, Singapore; School of Chemistry, Chemical Engineering and Biotechnology, Nanyang Technological University, Singapore; Department of Clinical Pharmacology, Medical University Vienna, Vienna, Austria; Center for Medical Physics and Biomedical Engineering, Medical University Vienna, Vienna, Austria; Institute of Molecular and Clinical Ophthalmology, Basel, Switzerland. Electronic address: leopold.schmetterer@meduniwien.ac.at.
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