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1. NIS Passenger: Eine nicht-interventionelle, multizentrische Studie zur Untersuchung von Wirksamkeit, Sicherheit und Lebensqualität bei nAMD Switch-Patientinnen und Patienten, die mit Faricimab unter Real-World-Bedingungen in Deutschland behandelt werden

Author

Heimes-Bussmann, B, Bellenbaum, R, Njoo, C, Liakopoulos, S, Schmitz-Valckenberg, S, Zortel, M, Rothaus, K, Mussinghoff, P, Lommatzsch, A, Heimes-Bussmann, B, Bellenbaum, R, Njoo, C, Liakopoulos, S, Schmitz-Valckenberg, S, Zortel, M, Rothaus, K, Mussinghoff, P, and Lommatzsch, A

Published
2024

2. NIS Passenger: Eine nicht-interventionelle, multizentrische Studie zur Untersuchung von Wirksamkeit, Sicherheit und Lebensqualität bei nAMD Switch-Patientinnen und Patienten, die mit Faricimab unter Real-World-Bedingungen in Deutschland behandelt werden

Author

Heimes-Bussmann, B, Bellenbaum, R, Njoo, C, Liakopoulos, S, Schmitz-Valckenberg, S, Zortel, M, Rothaus, K, Mussinghoff, P, Lommatzsch, A, Heimes-Bussmann, B, Bellenbaum, R, Njoo, C, Liakopoulos, S, Schmitz-Valckenberg, S, Zortel, M, Rothaus, K, Mussinghoff, P, and Lommatzsch, A

Published
2024

3. Functional characterization of the relative ellipsoid zone reflectivity in AMD

Author

Liermann, YN, Behning, C, Saßmannshausen, M, Weinhold, L, Isselmann, B, Schmid, M, Finger, RP, Schmitz-Valckenberg, S, Holz, FG, Pfau, M, Luu, CD, Thiele, S, Liermann, YN, Behning, C, Saßmannshausen, M, Weinhold, L, Isselmann, B, Schmid, M, Finger, RP, Schmitz-Valckenberg, S, Holz, FG, Pfau, M, Luu, CD, and Thiele, S

Published
2023

4. Repeatability of Quantitative Autofluorescence Imaging in a Multicenter Study Involving Patients With Recessive Stargardt Disease 1.

Author

Dhooge, P.P.A., Möller, P.T., Meland, N., Stingl, K., Boon, C.J.F., Lotery, A.J., Parodi, M.B., Herrmann, P., Klein, W., Fsadni, M.G., Wheeler-Schilling, T.H., Holz, F.G., Hoyng, C.B., Schmitz-Valckenberg, S., Dhooge, P.P.A., Möller, P.T., Meland, N., Stingl, K., Boon, C.J.F., Lotery, A.J., Parodi, M.B., Herrmann, P., Klein, W., Fsadni, M.G., Wheeler-Schilling, T.H., Holz, F.G., Hoyng, C.B., and Schmitz-Valckenberg, S.

Abstract

Item does not contain fulltext, PURPOSE: This study assesses the repeatability of quantitative autofluorescence (qAF) in a multicenter setting and evaluates qAF as the end point for clinical trials in recessive Stargardt disease 1 (STGD1). METHODS: A total of 102 patients with STGD1 underwent qAF imaging as part of the Stargardt Remofuscin Treatment Trial (STARTT; EudraCT No. 2018-001496-20). For 166 eyes, we obtained qAF imaging at 2 visits, with 2 recordings per visit. The qAF8 values were independently determined by the study site and a central reading center. Intra- and inter-visit reproducibility, as well as interobserver (study site versus reading center) reproducibility were obtained using intraclass correlation (ICC), one-sample t-test, and Bland-Altman coefficient of repeatability. RESULTS: The qAF repeatability was ± 26.1% for intra-visit, ± 40.5% for inter-visit, and ± 20.2% for the interobserver reproducibility measures. Intra-visit repeatability was good to excellent for all sites (ICC of 0.88-0.96). Variability between visits was higher with an overall ICC of 0.76 (0.69-0.81). We observed no significant difference in qAF values across sites between visits (7.06 ± 93.33, P = 0.238). CONCLUSIONS: Real-life test-retest variability of qAF is higher in this set of data than previously reported in single center settings. With improved operator training and by selecting the better of two recordings for evaluation, qAF serves as a useful method for assessing changes in autofluorescence signal. TRANSLATIONAL RELEVANCE: The qAF can be adopted as a clinical trial end point, but steps to counterbalance variability should be considered.

Published
2023

5. Functional characterization of the relative ellipsoid zone reflectivity in AMD

Author

Liermann, YN, Behning, C, Saßmannshausen, M, Weinhold, L, Isselmann, B, Schmid, M, Finger, RP, Schmitz-Valckenberg, S, Holz, FG, Pfau, M, Luu, CD, Thiele, S, Liermann, YN, Behning, C, Saßmannshausen, M, Weinhold, L, Isselmann, B, Schmid, M, Finger, RP, Schmitz-Valckenberg, S, Holz, FG, Pfau, M, Luu, CD, and Thiele, S

Published
2023

6. Prospective noninterventional BLUE SKY study evaluating the efficacy of brolucizumab in treatment-naive and previously treated patients with neovascular AMD

Author

Faatz, H., Feltgen, N., Gutfleisch, M., Heimes-Bussmann, B., Krohne, T. U., Liakopoulos, S., Liegl, R., Lommatzsch, A., Mussinghoff, P., Rehak, M., Schmitz-Valckenberg, S., Spital, G., Stanzel, B., Ziemssen, F., Haegele, B., Junkes, C., Porstner, M., Voegeler, J., Gmeiner, B., Pauleikhoff, D., Faatz, H., Feltgen, N., Gutfleisch, M., Heimes-Bussmann, B., Krohne, T. U., Liakopoulos, S., Liegl, R., Lommatzsch, A., Mussinghoff, P., Rehak, M., Schmitz-Valckenberg, S., Spital, G., Stanzel, B., Ziemssen, F., Haegele, B., Junkes, C., Porstner, M., Voegeler, J., Gmeiner, B., and Pauleikhoff, D.

Abstract

Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is the standard treatment for patients with neovascular age-related macular degeneration (nAMD). In addition to the approved substances ranibizumab (Lucentis (R), Novartis) and aflibercept (Eylea (R), Bayer), bevacizumab (Avastin (R), Roche) is also available. Furthermore, brolucizumab (Beovu (R), Novartis) has been approved and has been available in Germany since April 2020. The multicenter, noninterventional prospective BLUE SKY study investigates brolucizumab treatment with different schemes in 600 treatment-naive and pretreated nAMD patients in routine clinical practice over a 24-month period. Besides general patient data, visual acuity and treatment data will be documented. Fluorescein angiography, fundus photography, spectral domain optical coherence tomography and swept-source optical coherence tomography angiography will be performed and analyzed by reading centers. The focus of the analysis will be on the intraretinal and subretinal fluid distribution as well as morphological MNV changes and injection frequency. Also, safety and adverse drug effects of brolucizumab, with a specific focus on inflammatory complications, particularly retinal (occlusive) vasculitis will be evaluated.

Published
2023

7. Age-related macular degeneration

Author

Fleckenstein, Monika, Keenan, Tiarnan D.L., Guymer, Robyn H., Chakravarthy, U., Schmitz-Valckenberg, S., Klaver, C.C.W., Wong, Wai T., Chew, E.Y., Fleckenstein, Monika, Keenan, Tiarnan D.L., Guymer, Robyn H., Chakravarthy, U., Schmitz-Valckenberg, S., Klaver, C.C.W., Wong, Wai T., and Chew, E.Y.

Abstract

Item does not contain fulltext

Published
2021

8. The STArgardt Remofuscin Treatment Trial (STARTT): design and baseline characteristics of enrolled Stargardt patients

Author

Dhooge, P.P.A., Moller, P., Boon, C.J.F., Lotery, A.J., Herrmann, P., Battaglia Parodi, M., Klein, Wolfgang, Fsadni, M.G., Wheeler-Schilling, T.H., Jungman, O., Muller, Hans, Holz, F.G., Schmitz-Valckenberg, S., Peters, T.M., Stingl, Katarina, Hoyng, C.B., Dhooge, P.P.A., Moller, P., Boon, C.J.F., Lotery, A.J., Herrmann, P., Battaglia Parodi, M., Klein, Wolfgang, Fsadni, M.G., Wheeler-Schilling, T.H., Jungman, O., Muller, Hans, Holz, F.G., Schmitz-Valckenberg, S., Peters, T.M., Stingl, Katarina, and Hoyng, C.B.

Abstract

Contains fulltext : 246489.pdf (Publisher’s version ) (Open Access)

Published
2021

9. Fundus-controlled perimetry (microperimetry): Application as outcome measure in clinical trials

Author

Pfau, M, Jolly, JK, Wu, Z, Denniss, J, Lad, EM, Guymer, RH, Fleckenstein, M, Holz, FG, Schmitz-Valckenberg, S, Pfau, M, Jolly, JK, Wu, Z, Denniss, J, Lad, EM, Guymer, RH, Fleckenstein, M, Holz, FG, and Schmitz-Valckenberg, S

Abstract

Fundus-controlled perimetry (FCP, also called 'microperimetry') allows for spatially-resolved mapping of visual sensitivity and measurement of fixation stability, both in clinical practice as well as research. The accurate spatial characterization of visual function enabled by FCP can provide insightful information about disease severity and progression not reflected by best-corrected visual acuity in a large range of disorders. This is especially important for monitoring of retinal diseases that initially spare the central retina in earlier disease stages. Improved intra- and inter-session retest-variability through fundus-tracking and precise point-wise follow-up examinations even in patients with unstable fixation represent key advantages of these technique. The design of disease-specific test patterns and protocols reduces the burden of extensive and time-consuming FCP testing, permitting a more meaningful and focused application. Recent developments also allow for photoreceptor-specific testing through implementation of dark-adapted chromatic and photopic testing. A detailed understanding of the variety of available devices and test settings is a key prerequisite for the design and optimization of FCP protocols in future natural history studies and clinical trials. Accordingly, this review describes the theoretical and technical background of FCP, its prior application in clinical and research settings, data that qualify the application of FCP as an outcome measure in clinical trials as well as ongoing and future developments.

Published
2021

10. The STArgardt Remofuscin Treatment Trial (STARTT): design and baseline characteristics of enrolled Stargardt patients

Author

Dhooge, P.P.A., Moller, P., Boon, C.J.F., Lotery, A.J., Herrmann, P., Battaglia Parodi, M., Klein, Wolfgang, Fsadni, M.G., Wheeler-Schilling, T.H., Jungman, O., Muller, Hans, Holz, F.G., Schmitz-Valckenberg, S., Peters, T.M., Stingl, Katarina, Hoyng, C.B., Dhooge, P.P.A., Moller, P., Boon, C.J.F., Lotery, A.J., Herrmann, P., Battaglia Parodi, M., Klein, Wolfgang, Fsadni, M.G., Wheeler-Schilling, T.H., Jungman, O., Muller, Hans, Holz, F.G., Schmitz-Valckenberg, S., Peters, T.M., Stingl, Katarina, and Hoyng, C.B.

Abstract

Contains fulltext : 246489.pdf (Publisher’s version ) (Open Access)

Published
2021

11. Age-related macular degeneration

Author

Fleckenstein, Monika, Keenan, Tiarnan D.L., Guymer, Robyn H., Chakravarthy, U., Schmitz-Valckenberg, S., Klaver, C.C.W., Wong, Wai T., Chew, E.Y., Fleckenstein, Monika, Keenan, Tiarnan D.L., Guymer, Robyn H., Chakravarthy, U., Schmitz-Valckenberg, S., Klaver, C.C.W., Wong, Wai T., and Chew, E.Y.

Abstract

Item does not contain fulltext

Published
2021

12. Age-related macular degeneration

Author

Fleckenstein, Monika, Keenan, Tiarnan D.L., Guymer, Robyn H., Chakravarthy, U., Schmitz-Valckenberg, S., Klaver, C.C.W., Wong, Wai T., Chew, E.Y., Fleckenstein, Monika, Keenan, Tiarnan D.L., Guymer, Robyn H., Chakravarthy, U., Schmitz-Valckenberg, S., Klaver, C.C.W., Wong, Wai T., and Chew, E.Y.

Abstract

Item does not contain fulltext

Published
2021

13. Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR

Author

Terheyden, Jan H., Holz, Frank G., Schmitz-Valckenberg, S., Luning, A., Schmid, M., Rubin, Gary S., Sanchez, C.I., Hoyng, C.B., Leal, Sergio, Finger, R.P., Terheyden, Jan H., Holz, Frank G., Schmitz-Valckenberg, S., Luning, A., Schmid, M., Rubin, Gary S., Sanchez, C.I., Hoyng, C.B., Leal, Sergio, and Finger, R.P.

Abstract

Contains fulltext : 221442.pdf (publisher's version ) (Open Access)

Published
2020

16. Consensus Nomenclature for Reporting Neovascular Age-Related Macular Degeneration Data Consensus on Neovascular Age-Related Macular Degeneration Nomenclature Study Group

Author

Spaide, RF, Jaffe, GJ, Sarraf, D, Freund, KB, Sadda, SR, Staurenghi, G, Waheed, NK, Chakravarthy, U, Rosenfeld, PJ, Holz, FG, Souied, EH, Cohen, SY, Querques, G, Ohno-Matsui, K, Boyer, D, Gaudric, A, Blodi, B, Baumal, CR, Li, X, Coscas, GJ, Brucker, A, Singerman, L, Luthert, P, Schmitz-Valckenberg, S, Schmidt-Erfurth, U, Grossniklaus, HE, Wilson, DJ, Guymer, R, Yannuzzi, LA, Chew, EY, Csaky, K, Mones, JM, Pauleikhoff, D, Tadayoni, RR, Fujimoto, J, Spaide, RF, Jaffe, GJ, Sarraf, D, Freund, KB, Sadda, SR, Staurenghi, G, Waheed, NK, Chakravarthy, U, Rosenfeld, PJ, Holz, FG, Souied, EH, Cohen, SY, Querques, G, Ohno-Matsui, K, Boyer, D, Gaudric, A, Blodi, B, Baumal, CR, Li, X, Coscas, GJ, Brucker, A, Singerman, L, Luthert, P, Schmitz-Valckenberg, S, Schmidt-Erfurth, U, Grossniklaus, HE, Wilson, DJ, Guymer, R, Yannuzzi, LA, Chew, EY, Csaky, K, Mones, JM, Pauleikhoff, D, Tadayoni, RR, and Fujimoto, J

Abstract

PURPOSE: To establish a process to evaluate and standardize a state-of-the-art nomenclature for reporting neovascular age-related macular degeneration (AMD) data. DESIGN: Consensus meeting. PARTICIPANTS: An international panel of retina specialists, imaging and image reading center experts, and ocular pathologists. METHODS: During several meetings organized under the auspices of the Macula Society, an international study group discussed and codified a set nomenclature framework for classifying the subtypes of neovascular AMD and associated lesion components. MAIN OUTCOME MEASURES: A consensus classification of neovascular AMD. RESULTS: The study group created a standardized working definition of AMD. The components of neovascular AMD were defined and subclassified. Disease consequences of macular neovascularization were delineated. CONCLUSIONS: The framework of a consensus nomenclature system, a definition of AMD, and a delineation of the subtypes of neovascular AMD were developed. Establishing a uniform set of definitions will facilitate comparison of diverse patient groups and different studies. The framework presented is modified and updated readily, processes that are anticipated to occur on a periodic basis. The study group suggests that the consensus standards outlined in this article be used in future reported studies of neovascular AMD and clinical practice.

Published
2020

17. Incomplete Retinal Pigment Epithelial and Outer Retinal Atrophy in Age-Related Macular Degeneration Classification of Atrophy Meeting Report 4

Author

Guymer, RH, Rosenfeld, PJ, Curcio, CA, Holz, FG, Staurenghi, G, Freund, KB, Schmitz-Valckenberg, S, Sparrow, J, Spaide, RF, Tufail, A, Chakravarthy, U, Jaffe, GJ, Csaky, K, Sarraf, D, Mones, JM, Tadayoni, R, Grunwald, J, Bottoni, F, Liakopoulos, S, Pauleikhoff, D, Pagliarini, S, Chew, EY, Viola, F, Fleckenstein, M, Blodi, BA, Lim, TH, Chong, V, Lutty, J, Bird, AC, Sadda, SR, Guymer, RH, Rosenfeld, PJ, Curcio, CA, Holz, FG, Staurenghi, G, Freund, KB, Schmitz-Valckenberg, S, Sparrow, J, Spaide, RF, Tufail, A, Chakravarthy, U, Jaffe, GJ, Csaky, K, Sarraf, D, Mones, JM, Tadayoni, R, Grunwald, J, Bottoni, F, Liakopoulos, S, Pauleikhoff, D, Pagliarini, S, Chew, EY, Viola, F, Fleckenstein, M, Blodi, BA, Lim, TH, Chong, V, Lutty, J, Bird, AC, and Sadda, SR

Abstract

PURPOSE: To describe the defining features of incomplete retinal pigment epithelium (RPE) and outer retinal atrophy (iRORA), a consensus term referring to the OCT-based anatomic changes often identified before the development of complete RPE and outer retinal atrophy (cRORA) in age-related macular degeneration (AMD). We provide descriptive OCT and histologic examples of disease progression. DESIGN: Consensus meeting. PARTICIPANTS: Panel of retina specialists, including retinal imaging experts, reading center leaders, and retinal histologists. METHODS: As part of the Classification of Atrophy Meeting (CAM) program, an international group of experts analyzed and discussed longitudinal multimodal imaging of eyes with AMD. Consensus was reached on a classification system for OCT-based structural alterations that occurred before the development of atrophy secondary to AMD. New terms of iRORA and cRORA were defined. This report describes in detail the CAM consensus on iRORA. MAIN OUTCOME MEASURES: Defining the term iRORA through OCT imaging and longitudinal cases showing progression of atrophy, with histologic correlates. RESULTS: OCT was used in cases of early and intermediate AMD as the base imaging method to identify cases of iRORA. In the context of drusen, iRORA is defined on OCT as (1) a region of signal hypertransmission into the choroid, (2) a corresponding zone of attenuation or disruption of the RPE, and (3) evidence of overlying photoreceptor degeneration. The term iRORA should not be used when there is an RPE tear. Longitudinal studies confirmed the concept of progression from iRORA to cRORA. CONCLUSIONS: An international consensus classification for OCT-defined anatomic features of iRORA are described and examples of longitudinal progression to cRORA are provided. The ability to identify these OCT changes reproducibly is essential to understand better the natural history of the disease, to identify high-risk signs of progression, and to study early interventi

Published
2020

18. Validation of an Automated Quantification of Relative Ellipsoid Zone Reflectivity on Spectral Domain-Optical Coherence Tomography Images

Author

Thiele, S, Isselmann, B, Pfau, M, Holz, FG, Schmitz-Valckenberg, S, Wu, Z, Guymer, RH, Luu, CD, Thiele, S, Isselmann, B, Pfau, M, Holz, FG, Schmitz-Valckenberg, S, Wu, Z, Guymer, RH, and Luu, CD

Abstract

PURPOSE: Relative ellipsoid zone reflectivity (rEZR) represents a potential biomarker of photoreceptor health on spectral-domain optical coherence tomography (SD-OCT). Because manual quantification of rEZR is laborious and lacks of spatial resolution, automated quantification of the rEZR would be beneficial. The purpose of this study was to evaluate the reliability and reproducibility of an automated rEZR quantification method. METHODS: The rEZR was acquired using a manual and an automated approach in eyes with age-related macular degeneration (AMD) and healthy controls. The rEZR obtained from both methods was compared and the agreement between the methods and their reproducibility assessed. RESULTS: Forty eyes of 40 participants with a mean (± standard deviation) age of 65.2 ± 7.8 years were included. Both the manual and automated method showed that control eyes exhibit a greater rEZR than AMD eyes (P < 0.001). Overall, the limits of agreement between the manual and automated method were -7.5 to 7.3 arbitrary units (AU) and 95% of the data points had a difference in the rEZR between the methods of ±8.2%. An expected perfect reproducibility was observed for the automated method, whereas the manual method had a coefficient of repeatability of 6.3 arbitrary units. CONCLUSIONS: The automated quantification of rEZR method is reliable and reproducible. Further studies of the rEZR as a novel biomarker for AMD severity and progression are warranted. TRANSLATIONAL RELEVANCE: Automated quantification of SD-OCT-based rEZR allows for its comprehensive and longitudinal characterization evaluating its relevance as an in vivo biomarker of photoreceptor function and its prognostic value for AMD progression.

Published
2020

19. Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR

Author

Terheyden, Jan H., Holz, Frank G., Schmitz-Valckenberg, S., Luning, A., Schmid, M., Rubin, Gary S., Sanchez, C.I., Hoyng, C.B., Leal, Sergio, Finger, R.P., Terheyden, Jan H., Holz, Frank G., Schmitz-Valckenberg, S., Luning, A., Schmid, M., Rubin, Gary S., Sanchez, C.I., Hoyng, C.B., Leal, Sergio, and Finger, R.P.

Abstract

Contains fulltext : 221442.pdf (publisher's version ) (Open Access)

Published
2020

20. Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR

Author

Terheyden, Jan H., Holz, Frank G., Schmitz-Valckenberg, S., Luning, A., Schmid, M., Rubin, Gary S., Sanchez, C.I., Hoyng, C.B., Leal, Sergio, Finger, R.P., Terheyden, Jan H., Holz, Frank G., Schmitz-Valckenberg, S., Luning, A., Schmid, M., Rubin, Gary S., Sanchez, C.I., Hoyng, C.B., Leal, Sergio, and Finger, R.P.

Abstract

Contains fulltext : 221442.pdf (publisher's version ) (Open Access)

Published
2020

23. Fundusautofluoreszenz verschiedener Wellenlänge bei Morbus Stargardt

Author

Müller, PL, Pfau, M, Mauschitz, MM, Möller, PT, Birtel, J, Chang, P, Gliem, M, Schmitz-Valckenberg, S, Fleckenstein, M, Holz, FG, Herrmann, P, Müller, PL, Pfau, M, Mauschitz, MM, Möller, PT, Birtel, J, Chang, P, Gliem, M, Schmitz-Valckenberg, S, Fleckenstein, M, Holz, FG, and Herrmann, P

Published
2019

25. MACUSTAR: Development and Clinical Validation of Functional, Structural, and Patient-Reported Endpoints in Intermediate Age-Related Macular Degeneration

Author

Finger, R.P., Schmitz-Valckenberg, S., Schmid, M., Rubin, G.S., Dunbar, H., Tufail, A., Crabb, D.P., Binns, A., Sanchez, C.I., Margaron, P., Normand, G., Durbin, M.K., Luhmann, U.F., Zamiri, P., Cunha-Vaz, J., Asmus, F., Holz, F.G., Finger, R.P., Schmitz-Valckenberg, S., Schmid, M., Rubin, G.S., Dunbar, H., Tufail, A., Crabb, D.P., Binns, A., Sanchez, C.I., Margaron, P., Normand, G., Durbin, M.K., Luhmann, U.F., Zamiri, P., Cunha-Vaz, J., Asmus, F., and Holz, F.G.

Abstract

Contains fulltext : 203359.pdf (publisher's version ) (Open Access), PURPOSE: Currently, no outcome measures are clinically validated and accepted as clinical endpoints by regulatory agencies for drug development in intermediate age-related macular degeneration (iAMD). The MACUSTAR Consortium, a public-private research group funded by the European Innovative Medicines Initiative intends to close this gap. PROCEDURES: Development of study protocol and statistical analysis plan including predictive modelling of multimodal endpoints based on a review of the literature and expert consensus. RESULTS: This observational study consists of a cross-sectional and a longitudinal part. Functional outcome measures assessed under low contrast and low luminance have the potential to detect progression of visual deficit within iAMD and to late AMD. Structural outcome measures will be multimodal and investigate topographical relationships with function. Current patient-reported outcome measures (PROMs) are not acceptable to regulators and may not capture the functional deficit specific to iAMD with needed precision, justifying development of novel PROMs for iAMD. The total sample size will be n = 750, consisting mainly of subjects with iAMD (n = 600). CONCLUSIONS: As clinical endpoints currently accepted by regulators cannot detect functional loss or patient-relevant impact in iAMD, we will clinically validate novel candidate endpoints for iAMD.

Published
2019

26. The European Eye Epidemiology spectral-domain optical coherence tomography classification of macular diseases for epidemiological studies

Author

Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, T., Leung, Irene, Schmitz-Valckenberg, S., Oishi, Akio, Klaver, C.C.W., Jong, E.K. de, Hollander, A.I. den, Hoyng, C.B., Kersten, E., Lechanteur, Y.T., Sanchez, C.I., Yip, Jennifer, Zerbib, Jennyfer, Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, T., Leung, Irene, Schmitz-Valckenberg, S., Oishi, Akio, Klaver, C.C.W., Jong, E.K. de, Hollander, A.I. den, Hoyng, C.B., Kersten, E., Lechanteur, Y.T., Sanchez, C.I., Yip, Jennifer, and Zerbib, Jennyfer

Abstract

Contains fulltext : 203617.pdf (publisher's version ) (Closed access)

Published
2019

27. Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR

Author

Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D., Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., Zamiri, P., Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D., Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., and Zamiri, P.

Abstract

Background Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). Objective The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. Material and methods The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative 2 (IMI2) of the European Union. Results The MACUSTAR study consists of a cross-sectional and a longitudinal investigation. A total of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with a follow-up period of 3 years. Overall, 20 European study centers are involved. Conclusion The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.

Published
2019

28. Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR

Author

Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D. Sanches, Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., Zamiri, P., Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D. Sanches, Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., and Zamiri, P.

Abstract

Background. Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). Objective. The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. Material and methods. The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative 2 (IMI2) of the European Union. Results. The MACUSTAR study consists of a cross-sectional and a longitudinal investigation. A total of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with a follow-up period of 3 years. Overall, 20 European study centers are involved. Conclusion. The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.

Published
2019

29. MACUSTAR: Development and Clinical Validation of Functional, Structural, and Patient-Reported Endpoints in Intermediate Age-Related Macular Degeneration

Author

Finger, R.P., Schmitz-Valckenberg, S., Schmid, M., Rubin, G.S., Dunbar, H., Tufail, A., Crabb, D.P., Binns, A., Sanchez, C.I., Margaron, P., Normand, G., Durbin, M.K., Luhmann, U.F., Zamiri, P., Cunha-Vaz, J., Asmus, F., Holz, F.G., Finger, R.P., Schmitz-Valckenberg, S., Schmid, M., Rubin, G.S., Dunbar, H., Tufail, A., Crabb, D.P., Binns, A., Sanchez, C.I., Margaron, P., Normand, G., Durbin, M.K., Luhmann, U.F., Zamiri, P., Cunha-Vaz, J., Asmus, F., and Holz, F.G.

Abstract

Contains fulltext : 203359.pdf (publisher's version ) (Open Access), PURPOSE: Currently, no outcome measures are clinically validated and accepted as clinical endpoints by regulatory agencies for drug development in intermediate age-related macular degeneration (iAMD). The MACUSTAR Consortium, a public-private research group funded by the European Innovative Medicines Initiative intends to close this gap. PROCEDURES: Development of study protocol and statistical analysis plan including predictive modelling of multimodal endpoints based on a review of the literature and expert consensus. RESULTS: This observational study consists of a cross-sectional and a longitudinal part. Functional outcome measures assessed under low contrast and low luminance have the potential to detect progression of visual deficit within iAMD and to late AMD. Structural outcome measures will be multimodal and investigate topographical relationships with function. Current patient-reported outcome measures (PROMs) are not acceptable to regulators and may not capture the functional deficit specific to iAMD with needed precision, justifying development of novel PROMs for iAMD. The total sample size will be n = 750, consisting mainly of subjects with iAMD (n = 600). CONCLUSIONS: As clinical endpoints currently accepted by regulators cannot detect functional loss or patient-relevant impact in iAMD, we will clinically validate novel candidate endpoints for iAMD.

Published
2019

30. The European Eye Epidemiology spectral-domain optical coherence tomography classification of macular diseases for epidemiological studies

Author

Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, T., Leung, Irene, Schmitz-Valckenberg, S., Oishi, Akio, Klaver, C.C.W., Jong, E.K. de, Hollander, A.I. den, Hoyng, C.B., Kersten, E., Lechanteur, Y.T., Sanchez, C.I., Yip, Jennifer, Zerbib, Jennyfer, Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, T., Leung, Irene, Schmitz-Valckenberg, S., Oishi, Akio, Klaver, C.C.W., Jong, E.K. de, Hollander, A.I. den, Hoyng, C.B., Kersten, E., Lechanteur, Y.T., Sanchez, C.I., Yip, Jennifer, and Zerbib, Jennyfer

Abstract

Contains fulltext : 203617.pdf (publisher's version ) (Closed access)

Published
2019

31. The European Eye Epidemiology spectral-domain optical coherence tomography classification of macular diseases for epidemiological studies

Author

Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, T., Leung, Irene, Schmitz-Valckenberg, S., Oishi, Akio, Klaver, C.C.W., Jong, E.K. de, Hollander, A.I. den, Hoyng, C.B., Kersten, E., Lechanteur, Y.T., Sanchez, C.I., Yip, Jennifer, Zerbib, Jennyfer, Gattoussi, Sarra, Buitendijk, Gabrielle H. S., Peto, T., Leung, Irene, Schmitz-Valckenberg, S., Oishi, Akio, Klaver, C.C.W., Jong, E.K. de, Hollander, A.I. den, Hoyng, C.B., Kersten, E., Lechanteur, Y.T., Sanchez, C.I., Yip, Jennifer, and Zerbib, Jennyfer

Abstract

Contains fulltext : 203617.pdf (publisher's version ) (Closed access)

Published
2019

32. Vorkommen und Progression von Atrophiearealen bei pathologischer Myopie

Author

Melzer, C, Ziemssen, F, Eter, N, Brinkmann, C, Agostini, H, Haeusser-Fruh, G, Rose, U, Schargus, M, Lorenz, K, Holz, F, Schmitz-Valckenberg, S, Melzer, C, Ziemssen, F, Eter, N, Brinkmann, C, Agostini, H, Haeusser-Fruh, G, Rose, U, Schargus, M, Lorenz, K, Holz, F, and Schmitz-Valckenberg, S

Published
2019

34. Fundusautofluoreszenz verschiedener Wellenlänge bei Morbus Stargardt

Author

Müller, PL, Pfau, M, Mauschitz, MM, Möller, PT, Birtel, J, Chang, P, Gliem, M, Schmitz-Valckenberg, S, Fleckenstein, M, Holz, FG, Herrmann, P, Müller, PL, Pfau, M, Mauschitz, MM, Möller, PT, Birtel, J, Chang, P, Gliem, M, Schmitz-Valckenberg, S, Fleckenstein, M, Holz, FG, and Herrmann, P

Published
2019

35. Vorkommen und Progression von Atrophiearealen bei pathologischer Myopie

Author

Melzer, C, Ziemssen, F, Eter, N, Brinkmann, C, Agostini, H, Haeusser-Fruh, G, Rose, U, Schargus, M, Lorenz, K, Holz, F, Schmitz-Valckenberg, S, Melzer, C, Ziemssen, F, Eter, N, Brinkmann, C, Agostini, H, Haeusser-Fruh, G, Rose, U, Schargus, M, Lorenz, K, Holz, F, and Schmitz-Valckenberg, S

Published
2019

38. Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR

Author

Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D. Sanches, Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., Zamiri, P., Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D. Sanches, Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., and Zamiri, P.

Abstract

Background. Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). Objective. The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. Material and methods. The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative 2 (IMI2) of the European Union. Results. The MACUSTAR study consists of a cross-sectional and a longitudinal investigation. A total of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with a follow-up period of 3 years. Overall, 20 European study centers are involved. Conclusion. The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.

Published
2019

39. Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR

Author

Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D., Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., Zamiri, P., Terheyden, Jan H., Finger, Robert P., Schmitz-Valckenberg, Steffen, Agostini, Hansjuergen, Dahlke, Claudia, Kuehlewein, Laura, Lang, Gabriele E., Pauleikhoff, Daniel, Wolf, Armin, Boettger, Michael K., Luhmann, Ulrich F. O., Asmus, Friedrich, Holz, Frank G., Asmus, F., Berger, M., Binns, A., Boettger, M., Bouchet, C., Brazier, J. E., Butt, T., Carapezzi, C., Carlton, J., Costa, M., Crabb, D. P., Cunha-Vaz, J., Dunbar, H., Durbin, M., Finger, R., Holz, F., Hoyng, C., Kraetzschmar, J., Luhmann, U., Luening, A., Margaron, Ph., Martinho, C., Melicio, B., Normand, G., Rowen, D., Rubin, G. S., Sahel, J., Sanchez, C. I., Fernandes, D., Schmid, M., Schmitz-Valckenberg, S., Skelly, A., Terheyden, J., Tufail, A., Wojek, C., and Zamiri, P.

Abstract

Background Currently, no validated clinical endpoints for treatment studies exist for intermediate age-related macular degeneration (iAMD). Objective The European MACUSTAR study aims to develop and clinically validate adequate clinical endpoints for future treatment studies in iAMD and to identify early determinants of disease progression to late stage AMD. Material and methods The MACUSTAR study protocol was developed by an international consortium of researchers from academia, the pharmaceutical industry and medical device companies. The MACUSTAR project is funded by the Innovative Medicines Initiative 2 (IMI2) of the European Union. Results The MACUSTAR study consists of a cross-sectional and a longitudinal investigation. A total of 750 subjects with early, intermediate and late AMD as well as control subjects with no signs of AMD will be included with a follow-up period of 3 years. Overall, 20 European study centers are involved. Conclusion The MACUSTAR project will generate large high-quality datasets, which will allow clinical validation of novel endpoints for future interventional trials in iAMD. The aim is that these endpoints will be accepted as suitable for medication approval studies by the regulatory authorities and that understanding of the disease process will be improved.

Published
2019

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