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., 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. (2019). Development and validation of novel clinical endpoints in intermediate age-related macular degeneration in MACUSTAR. Ophthalmologe, 116 (12). S. 1186 - 1194. HEIDELBERG: SPRINGER HEIDELBERG. ISSN 1433-0423

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Terheyden, Jan H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Finger, Robert P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmitz-Valckenberg, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Agostini, HansjuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dahlke, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuehlewein, LauraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lang, Gabriele E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pauleikhoff, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, ArminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettger, Michael K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luhmann, Ulrich F. O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Asmus, FriedrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holz, Frank G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Asmus, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Asmus, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berger, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Binns, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettger, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bouchet, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brazier, J. E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Butt, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carapezzi, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Carlton, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Costa, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Crabb, D. P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cunha-Vaz, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dunbar, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Durbin, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Finger, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holz, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoyng, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kraetzschmar, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luhmann, U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luening, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Margaron, Ph.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martinho, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Melicio, B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Normand, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rowen, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rubin, G. S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sahel, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sanchez, C. I.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fernandes, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmid, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmitz-Valckenberg, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Skelly, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Terheyden, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tufail, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wojek, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zamiri, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-125006
DOI: 10.1007/s00347-019-0907-1
Journal or Publication Title: Ophthalmologe
Volume: 116
Number: 12
Page Range: S. 1186 - 1194
Date: 2019
Publisher: SPRINGER HEIDELBERG
Place of Publication: HEIDELBERG
ISSN: 1433-0423
Language: German
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
VISUAL-ACUITY LOSS; GEOGRAPHIC ATROPHY; DARK-ADAPTATION; MICROPERIMETRY; DRUSEN; DYSFUNCTION; IMPAIRMENT; PREVALENCEMultiple languages
OphthalmologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/12500

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