PMID- 35333287 OWN - NLM STAT- MEDLINE DCOM- 20220405 LR - 20220512 IS - 2164-2591 (Electronic) IS - 2164-2591 (Linking) VI - 11 IP - 3 DP - 2022 Mar 2 TI - Intersession Repeatability of Structural Biomarkers in Early and Intermediate Age-Related Macular Degeneration: A MACUSTAR Study Report. PG - 27 LID - 10.1167/tvst.11.3.27 [doi] LID - 27 AB - PURPOSE: To analyze the intersession repeatability of structural biomarkers in eyes with early and intermediate age-related macular degeneration (iAMD) within the cross-sectional part of the observational multicenter MACUSTAR study. METHODS: Certified site personnel obtained multimodal imaging data at two visits (38 +/- 20 [mean +/- standard deviation] days apart), including spectral-domain optical coherence tomography (SD-OCT). One junior reader performed systematic and blinded grading at the central reading center, followed by senior reader review. Structural biomarkers included maximum drusen size classification (>63 to 125 microm), presence of large pigment epithelium detachments (PEDs), reticular pseudodrusen (RPD), vitelliform lesions, and refractile deposits. Intrasession variability was assessed using Cohen's kappa statistics. RESULTS: At the first visit, 202 study eyes of 202 participants were graded as manifesting with either early (n = 34) or intermediate (n = 168) AMD. Grading of imaging data between visits revealed perfect agreement for the maximum drusen size classification (kappa = 0.817; 95% confidence interval, 0.70-0.94). In iAMD eyes, perfect to substantial agreement was determined for the presence of large PEDs (0.87; 0.69-1.00) and RPD (0.752; 0.63-0.87), while intersession agreement was lower for the presence of vitelliform lesions (0.649; 0.39-0.65) and refractile deposits (0.342; -0.029-0.713), respectively. CONCLUSIONS: Multimodal retinal imaging analysis between sessions showed a higher repeatability for structural biomarkers with predefined cutoff values than purely qualitative defined parameters. TRANSLATIONAL RELEVANCE: A high repeatability of retinal imaging biomarkers will be important to implement automatic grading approaches and to establish robust and meaningful structural clinical endpoints for future interventional clinical trials in patients with iAMD. FAU - Sassmannshausen, Marlene AU - Sassmannshausen M AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. AD - GRADE Reading Center, University of Bonn, Bonn, Germany. FAU - Thiele, Sarah AU - Thiele S AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. AD - GRADE Reading Center, University of Bonn, Bonn, Germany. FAU - Behning, Charlotte AU - Behning C AD - Institute of Medical Biometry, Informatics and Epidemiology, Medical Faculty, University of Bonn, Bonn, Germany. FAU - Pfau, Maximilian AU - Pfau M AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. AD - GRADE Reading Center, University of Bonn, Bonn, Germany. AD - Ophthalmic Genetics and Visual Function Branch, National Eye Institute, Bethesda, MD, USA. FAU - Schmid, Matthias AU - Schmid M AD - Institute of Medical Biometry, Informatics and Epidemiology, Medical Faculty, University of Bonn, Bonn, Germany. FAU - Leal, Sergio AU - Leal S AD - Bayer AG, Berlin, Germany. FAU - Luhmann, Ulrich F O AU - Luhmann UFO AD - Roche Pharmaceutical Research and Early Development, Translational Medicine Ophthalmology, Roche Innovation Center Basel, Basel, Switzerland. FAU - Finger, Robert P AU - Finger RP AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. FAU - Holz, Frank G AU - Holz FG AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. AD - GRADE Reading Center, University of Bonn, Bonn, Germany. FAU - Schmitz-Valckenberg, Steffen AU - Schmitz-Valckenberg S AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. AD - GRADE Reading Center, University of Bonn, Bonn, Germany. AD - John A. Moran Eye Center, Department of Ophthalmology & Visual Sciences, University of Utah, Salt Lake City, UT, USA. CN - MACUSTAR Consortium LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Transl Vis Sci Technol JT - Translational vision science & technology JID - 101595919 RN - 0 (Biomarkers) SB - IM MH - Biomarkers MH - Cross-Sectional Studies MH - Humans MH - *Macular Degeneration/diagnostic imaging MH - *Retinal Drusen/diagnostic imaging MH - Tomography, Optical Coherence/methods PMC - PMC8963672 COIS- Disclosure: M. Sassmannshausen, Heidelberg Engineering (F), CenterVue (F), Carl Zeiss MedicTec (F); S. Thiele, Allergan (R), Bayer (R), Carl Zeiss MedicTec AG (F), CenterVue (F), Heidelberg Engineering (R, F), Optos (F), Novartis (R, F); C. Behning, None; M. Pfau, Apellis (C); M. Schmid, None; S. Leal, Bayer (E); U.F.O. Luhmann, F. Hoffmann-La Roche Ltd (E); R.P. Finger, Alimera (C), Bayer (C, F), Boehringer-Ingelheim (C), Bioqen (F), CenterVue (F), Ellex (C), Roche/Genentech (C), Heidelberg Engineering (F), Novartis (C, F), Santhera (C), Zeiss (F); F.G. Holz, Acucela (C, F), Allergan (F), Apellis (C, F), Bayer (C, F), Boehringer-Ingelheim (C), Bioeq/Formycon (F, C), CenterVue (F), Ellex (F), Roche/Genentech (C, F), Geuder (C, F), Graybug (C), Gyroscope (C), Heidelberg Engineering (C, F), IvericBio (C, F), Kanghong (C, F), LinBioscience (C), NightStarX (F), Novartis (C, F), Optos (F), Oxurion (C), Pixium Vision (C, F), Oxurion (C), Stealth BioTherapeutics (C), Zeiss (F, C); S. Schmitz-Valckenberg, AlphaRET (C), Apellis (C, R), Bayer (F), Bioeq (C), Carl Zeiss MediTec (F), Heidelberg Engineering (F, R), Katairo (C), Kubota Vision (C), Novartis (C, F), Oxurion (C), Pixium (C), Roche (C, F), SparingVision (C), STZ GRADE Reading Center (O) EDAT- 2022/03/26 06:00 MHDA- 2022/04/05 06:00 PMCR- 2022/03/25 CRDT- 2022/03/25 12:10 PHST- 2022/03/25 12:10 [entrez] PHST- 2022/03/26 06:00 [pubmed] PHST- 2022/04/05 06:00 [medline] PHST- 2022/03/25 00:00 [pmc-release] AID - 2778698 [pii] AID - TVST-21-4284 [pii] AID - 10.1167/tvst.11.3.27 [doi] PST - ppublish SO - Transl Vis Sci Technol. 2022 Mar 2;11(3):27. doi: 10.1167/tvst.11.3.27.