Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration

Recommendations from Classification of Atrophy Consensus Meetings

Frank G. Holz, Srini Vas R. Sadda, Giovanni Staurenghi, Moritz Lindner, Alan C. Bird, Barbara A. Blodi, Ferdinando Bottoni, Usha Chakravarthy, Emily Y. Chew, Karl Csaky, Christine A. Curcio, Ron Danis, Monika Fleckenstein, K Bailey Freund, Juan Grunwald, Robyn Guymer, Carel B. Hoyng, Glenn J. Jaffe, Sandra Liakopoulos, Jordi M. Monés & 10 others Akio Oishi, Daniel Pauleikhoff, Philip J. Rosenfeld, David Sarraf, Richard F. Spaide, Ramin Tadayoni, Adnan Tufail, Sebastian Wolf, Steffen Schmitz-Valckenberg, CAM group

Research output: Contribution to journalArticleResearchpeer-review

51 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)464-478
Number of pages15
JournalOphthalmology
Volume124
Issue number4
DOIs
Publication statusPublished - 1 Apr 2017
Externally publishedYes

Cite this

Holz, Frank G. ; Sadda, Srini Vas R. ; Staurenghi, Giovanni ; Lindner, Moritz ; Bird, Alan C. ; Blodi, Barbara A. ; Bottoni, Ferdinando ; Chakravarthy, Usha ; Chew, Emily Y. ; Csaky, Karl ; Curcio, Christine A. ; Danis, Ron ; Fleckenstein, Monika ; Freund, K Bailey ; Grunwald, Juan ; Guymer, Robyn ; Hoyng, Carel B. ; Jaffe, Glenn J. ; Liakopoulos, Sandra ; Monés, Jordi M. ; Oishi, Akio ; Pauleikhoff, Daniel ; Rosenfeld, Philip J. ; Sarraf, David ; Spaide, Richard F. ; Tadayoni, Ramin ; Tufail, Adnan ; Wolf, Sebastian ; Schmitz-Valckenberg, Steffen ; CAM group. / Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration : Recommendations from Classification of Atrophy Consensus Meetings. In: Ophthalmology. 2017 ; Vol. 124, No. 4. pp. 464-478.
@article{11e36d9b6e1f41c6b64385201bb0dd2d,
title = "Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration: Recommendations from Classification of Atrophy Consensus Meetings",
abstract = "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.",
author = "Holz, {Frank G.} and Sadda, {Srini Vas R.} and Giovanni Staurenghi and Moritz Lindner and Bird, {Alan C.} and Blodi, {Barbara A.} and Ferdinando Bottoni and Usha Chakravarthy and Chew, {Emily Y.} and Karl Csaky and Curcio, {Christine A.} and Ron Danis and Monika Fleckenstein and Freund, {K Bailey} and Juan Grunwald and Robyn Guymer and Hoyng, {Carel B.} and Jaffe, {Glenn J.} and Sandra Liakopoulos and Mon{\'e}s, {Jordi M.} and Akio Oishi and Daniel Pauleikhoff and Rosenfeld, {Philip J.} and David Sarraf and Spaide, {Richard F.} and Ramin Tadayoni and Adnan Tufail and Sebastian Wolf and Steffen Schmitz-Valckenberg and {CAM group}",
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pages = "464--478",
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Holz, FG, Sadda, SVR, Staurenghi, G, Lindner, M, Bird, AC, Blodi, BA, Bottoni, F, Chakravarthy, U, Chew, EY, Csaky, K, Curcio, CA, Danis, R, Fleckenstein, M, Freund, KB, Grunwald, J, Guymer, R, Hoyng, CB, Jaffe, GJ, Liakopoulos, S, Monés, JM, Oishi, A, Pauleikhoff, D, Rosenfeld, PJ, Sarraf, D, Spaide, RF, Tadayoni, R, Tufail, A, Wolf, S, Schmitz-Valckenberg, S & CAM group 2017, 'Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration: Recommendations from Classification of Atrophy Consensus Meetings', Ophthalmology, vol. 124, no. 4, pp. 464-478. https://doi.org/10.1016/j.ophtha.2016.12.002

Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration : Recommendations from Classification of Atrophy Consensus Meetings. / Holz, Frank G.; Sadda, Srini Vas R.; Staurenghi, Giovanni; Lindner, Moritz; Bird, Alan C.; Blodi, Barbara A.; Bottoni, Ferdinando; Chakravarthy, Usha; Chew, Emily Y.; Csaky, Karl; Curcio, Christine A.; Danis, Ron; Fleckenstein, Monika; Freund, K Bailey; Grunwald, Juan; Guymer, Robyn; Hoyng, Carel B.; Jaffe, Glenn J.; Liakopoulos, Sandra; Monés, Jordi M.; Oishi, Akio; Pauleikhoff, Daniel; Rosenfeld, Philip J.; Sarraf, David; Spaide, Richard F.; Tadayoni, Ramin; Tufail, Adnan; Wolf, Sebastian; Schmitz-Valckenberg, Steffen; CAM group.

In: Ophthalmology, Vol. 124, No. 4, 01.04.2017, p. 464-478.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration

T2 - Recommendations from Classification of Atrophy Consensus Meetings

AU - Holz, Frank G.

AU - Sadda, Srini Vas R.

AU - Staurenghi, Giovanni

AU - Lindner, Moritz

AU - Bird, Alan C.

AU - Blodi, Barbara A.

AU - Bottoni, Ferdinando

AU - Chakravarthy, Usha

AU - Chew, Emily Y.

AU - Csaky, Karl

AU - Curcio, Christine A.

AU - Danis, Ron

AU - Fleckenstein, Monika

AU - Freund, K Bailey

AU - Grunwald, Juan

AU - Guymer, Robyn

AU - Hoyng, Carel B.

AU - Jaffe, Glenn J.

AU - Liakopoulos, Sandra

AU - Monés, Jordi M.

AU - Oishi, Akio

AU - Pauleikhoff, Daniel

AU - Rosenfeld, Philip J.

AU - Sarraf, David

AU - Spaide, Richard F.

AU - Tadayoni, Ramin

AU - Tufail, Adnan

AU - Wolf, Sebastian

AU - Schmitz-Valckenberg, Steffen

AU - CAM group

PY - 2017/4/1

Y1 - 2017/4/1

N2 - 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.

AB - 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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