title: Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration: Recommendations from Classification of Atrophy Consensus Meetings.
abstract: 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.
  
  
  
  Systematic debate on the relevance of distinct imaging modalities held in 2 consensus meetings.
  
  
  
  A panel of retina specialists.
  
  
  
  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.
  
  
  
  Advantages and disadvantages of current retinal imaging technologies and recommendations for their use in advanced AMD trials.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany. Electronic address: Frank.Holz@ukb.uni-bonn.de.
authors.forename: Frank G
authors.initials: FG
authors.lastname: Holz
authors.affiliation: Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.
authors.forename: SriniVas R
authors.initials: SR
authors.lastname: Sadda
authors.affiliation: Eye Clinic, Department of Biomedical and Clinical Sciences "Luigi Sacco," Luigi Sacco Hospital, University of Milan, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Staurenghi
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: Moritz
authors.initials: M
authors.lastname: Lindner
authors.affiliation: Institute of Ophthalmology, University College London, London, United Kingdom.
authors.forename: Alan C
authors.initials: AC
authors.lastname: Bird
authors.affiliation: Department of Ophthalmology and Visual Sciences, Fundus Photograph Reading Center, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Blodi
authors.affiliation: Eye Clinic, Department of Biomedical and Clinical Sciences "Luigi Sacco," Luigi Sacco Hospital, University of Milan, Milan, Italy.
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Bottoni
authors.affiliation: Institute of Clinical Science, The Queen's University of Belfast, Belfast, United Kingdom.
authors.forename: Usha
authors.initials: U
authors.lastname: Chakravarthy
authors.affiliation: National Eye Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Emily Y
authors.initials: EY
authors.lastname: Chew
authors.affiliation: Texas Retina Associates, Dallas, Texas.
authors.forename: Karl
authors.initials: K
authors.lastname: Csaky
authors.affiliation: Department of Ophthalmology, University of Alabama School of Medicine, Birmingham, Alabama.
authors.forename: Christine A
authors.initials: CA
authors.lastname: Curcio
authors.affiliation: Department of Ophthalmology and Visual Sciences, Fundus Photograph Reading Center, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
authors.forename: Ron
authors.initials: R
authors.lastname: Danis
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Fleckenstein
authors.affiliation: Vitreous Retina Macula Consultants of New York, New York, New York.
authors.forename: K Bailey
authors.initials: KB
authors.lastname: Freund
authors.affiliation: Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Juan
authors.initials: J
authors.lastname: Grunwald
authors.affiliation: Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, Department of Surgery (Ophthalmology) Melbourne, Australia.
authors.forename: Robyn
authors.initials: R
authors.lastname: Guymer
authors.affiliation: Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Carel B
authors.initials: CB
authors.lastname: Hoyng
authors.affiliation: Department of Ophthalmology, Duke Reading Center, Duke University, Durham, North Carolina.
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Jaffe
authors.affiliation: Department of Ophthalmology, Cologne Image Reading Center, University of Cologne, Cologne, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Liakopoulos
authors.affiliation: Institut de la Màcula and Barcelona Macula Foundation, Barcelona, Spain.
authors.forename: Jordi M
authors.initials: JM
authors.lastname: Monés
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: Akio
authors.initials: A
authors.lastname: Oishi
authors.affiliation: Department of Ophthalmology, St. Franziskus Hospital, Münster, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pauleikhoff
authors.affiliation: Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Rosenfeld
authors.affiliation: Stein Eye Institute, David Geffen School of Medicine, University of California, Los Angeles, California.
authors.forename: David
authors.initials: D
authors.lastname: Sarraf
authors.affiliation: Vitreous Retina Macula Consultants of New York, New York, New York.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Spaide
authors.affiliation: Ophthalmology Department, Hôpital Lariboisière, AP-HP, Université Paris 7 - Sorbonne Paris Cité, Paris, France.
authors.forename: Ramin
authors.initials: R
authors.lastname: Tadayoni
authors.affiliation: Moorfields Eye Hospital, London, United Kingdom.
authors.forename: Adnan
authors.initials: A
authors.lastname: Tufail
authors.affiliation: Department of Ophthalmology, University Hospital Bern, University of Bern, Bern, Switzerland.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Wolf
authors.affiliation: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schmitz-Valckenberg
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D005260:Female; D005451:Fluorescein Angiography; D057092:Geographic Atrophy / Q000145:classification* / Q000000981:diagnostic imaging*; D006801:Humans; D007208:Indocyanine Green / Q000008:administration & dosage; D008297:Male; D064847:Multimodal Imaging; D061848:Optical Imaging; D010781:Photography; D055213:Retinal Pigment Epithelium / Q000473:pathology; D041623:Tomography, Optical Coherence; D057135:Wet Macular Degeneration / Q000145:classification* / Q000000981:diagnostic imaging*
chemical_list: D007208:Indocyanine Green