Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration: Recommendations from Classification of Atrophy Consensus Meetings.
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Holz FG
Department of Ophthalmology, University of Bonn, Bonn, Germany. Electronic address: Frank.Holz@ukb.uni-bonn.de.
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Sadda SR
Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.
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Staurenghi G
Eye Clinic, Department of Biomedical and Clinical Sciences "Luigi Sacco," Luigi Sacco Hospital, University of Milan, Milan, Italy.
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Lindner M
Department of Ophthalmology, University of Bonn, Bonn, Germany.
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Bird AC
Institute of Ophthalmology, University College London, London, United Kingdom.
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Blodi BA
Department of Ophthalmology and Visual Sciences, Fundus Photograph Reading Center, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
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Bottoni F
Eye Clinic, Department of Biomedical and Clinical Sciences "Luigi Sacco," Luigi Sacco Hospital, University of Milan, Milan, Italy.
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Chakravarthy U
Institute of Clinical Science, The Queen's University of Belfast, Belfast, United Kingdom.
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Chew EY
National Eye Institute, National Institutes of Health, Bethesda, Maryland.
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Csaky K
Texas Retina Associates, Dallas, Texas.
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Curcio CA
Department of Ophthalmology, University of Alabama School of Medicine, Birmingham, Alabama.
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Danis R
Department of Ophthalmology and Visual Sciences, Fundus Photograph Reading Center, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
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Fleckenstein M
Department of Ophthalmology, University of Bonn, Bonn, Germany.
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Freund KB
Vitreous Retina Macula Consultants of New York, New York, New York.
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Grunwald J
Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.
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Guymer R
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, Department of Surgery (Ophthalmology) Melbourne, Australia.
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Hoyng CB
Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.
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Jaffe GJ
Department of Ophthalmology, Duke Reading Center, Duke University, Durham, North Carolina.
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Liakopoulos S
Department of Ophthalmology, Cologne Image Reading Center, University of Cologne, Cologne, Germany.
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Monés JM
Institut de la Màcula and Barcelona Macula Foundation, Barcelona, Spain.
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Oishi A
Department of Ophthalmology, University of Bonn, Bonn, Germany.
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Pauleikhoff D
Department of Ophthalmology, St. Franziskus Hospital, Münster, Germany.
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Rosenfeld PJ
Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
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Sarraf D
Stein Eye Institute, David Geffen School of Medicine, University of California, Los Angeles, California.
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Spaide RF
Vitreous Retina Macula Consultants of New York, New York, New York.
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Tadayoni R
Ophthalmology Department, Hôpital Lariboisière, AP-HP, Université Paris 7 - Sorbonne Paris Cité, Paris, France.
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Tufail A
Moorfields Eye Hospital, London, United Kingdom.
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Wolf S
Department of Ophthalmology, University Hospital Bern, University of Bern, Bern, Switzerland.
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Schmitz-Valckenberg S
Department of Ophthalmology, University of Bonn, Bonn, Germany.
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English
PURPOSE
To summarize the results of 2 consensus meetings (Classification of Atrophy Meeting [CAM]) on conventional and advanced imaging modalities used to detect and quantify atrophy due to late-stage non-neovascular and neovascular age-related macular degeneration (AMD) and to provide recommendations on the use of these modalities in natural history studies and interventional clinical trials.
DESIGN
Systematic debate on the relevance of distinct imaging modalities held in 2 consensus meetings.
PARTICIPANTS
A panel of retina specialists.
METHODS
During the CAM, a consortium of international experts evaluated the advantages and disadvantages of various imaging modalities on the basis of the collective analysis of a large series of clinical cases. A systematic discussion on the role of each modality in future studies in non-neovascular and neovascular AMD was held.
MAIN OUTCOME MEASURES
Advantages and disadvantages of current retinal imaging technologies and recommendations for their use in advanced AMD trials.
RESULTS
Imaging protocols to detect, quantify, and monitor progression of atrophy should include color fundus photography (CFP), confocal fundus autofluorescence (FAF), confocal near-infrared reflectance (NIR), and high-resolution optical coherence tomography volume scans. These images should be acquired at regular intervals throughout the study. In studies of non-neovascular AMD (without evident signs of active or regressed neovascularization [NV] at baseline), CFP may be sufficient at baseline and end-of-study visit. Fluorescein angiography (FA) may become necessary to evaluate for NV at any visit during the study. Indocyanine-green angiography (ICG-A) may be considered at baseline under certain conditions. For studies in patients with neovascular AMD, increased need for visualization of the vasculature must be taken into account. Accordingly, these studies should include FA (recommended at baseline and selected follow-up visits) and ICG-A under certain conditions.
CONCLUSIONS
A multimodal imaging approach is recommended in clinical studies for the optimal detection and measurement of atrophy and its associated features. Specific validation studies will be necessary to determine the best combination of imaging modalities, and these recommendations will need to be updated as new imaging technologies become available in the future.
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Language
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Open access status
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bronze
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Identifiers
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Persistent URL
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https://sonar.ch/global/documents/157068
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