Joussen AM, Kirchhof B, Schrage N, Ocklenburg C, Hilgers RD, on behalf of the HSO Study Group: Heavy silicone oil versus standard silicone oil as vitreous tamponade in inferior PVR (HSO Study): design issues and implications. Acta Opthalmologica Scandinavica 2007; 85(6):623-30.
IDeAl – Integrated Design and Analysis for Small Population Group Trials
An international researcher-team under the coordination of Professor Ralf-Dieter Hilgers of the RWTH Aachen will jointly develop new designs and sophisticated analysis methods for the evaluation of therapies for rare diseases, supported by the EU Projectmanagement Office der RWTH Aachen. The research is funded by the 7th Framework Programme of the European Union (FP7-HEALTH-2013-INNOVATION-1, No. 602 552).
The consortium consist of Professor Ralf-Dieter Hilgers, RWTH Aachen University, Professor Holger Dette, Ruhr University Bochum, Franz König, Medical University of Vienna, Professor France Mentré, Institut National de la Santé et de la Recherche Medicale in Paris, Professor Stephen Senn, Centre de Recherche Public de la Santé Luxembourg, Professor Mats Karlsson, Uppsala University, Uppsala, Professor Malgorzata Bogdan, Polytechnika Wroclawska, Warsaw, Dr. Carl-Fredrik Burman, Chalmers University of Technology, Gothenburg, Professor Geert Molenberghs, University Hasselt, Hasselt and Professor Christoph Male, Medical University of Vienna. The research programme is divided into 11 work packages.
The work packages focus on the assessment of randomization, the extrapolation of dose-response information, the study of adaptive trial designs, the development of optimal experimental designs in mixed models, as well as pharmacokinetic and individualized designs, simulation of clinical studies, the involvement and identification of genetic factors, decision-theoretic considerations, as well as the evaluation of biomarkers.
Lucentis-DME-ERG - Behandlung des diabetischen Makulaödems mit 0.5mg intraocularen Ranibizumab
Die Lucentis Studie ist eine open label, prospektive, monozentrische kontrollierte klinische Studie mit einem Therapiearm. Sie dient der Erforschung der Wirkung von 0.5mg intraocularen Ranibizumab (Lucentis) bei der Behandlung des diabetischen Makulaödems.
Es werden Kurz- und Langzeiteffekte auf die retinale Funktion, bei Patienten mit einer diabetischen Makularerkrankung über 12 Monate evaluiert.
Laufzeit: 01.12.2011 – 30.07.2014 (first patient in, last patient out)
Im Rahmen des Projektes wurden sicherere und kosteneffizientere Arzneimittelentwicklung unter Verwendung von optimalen Experimentdesigns (SkAVoE) entwickelt. Das Forschungsprojekt wurde von Professor Holger Dette (Ruhrunversität Bochum) koordiniert. In weiteren Teilprojekten forschten Professor Ralf-Dieter Hilgers (RWTH Aachen), Professor Joachim Kunert (Technische Universität Dortmund) sowie Professor Rainer Schwabe (Otto-von-Guericke-Universität Magdeburg) an unterschiedlichen Themen. Das Teilprojekt „Experimentdesign für mehrfaktorielle Zwei-Farben Microarrays“ wurde im Institut für Medizinische Statistik bearbeitet und konzentrierte sich auf die Entwicklung von optimalen und robusten Blockdesigns zur Planung und Auswertung von Zwei-Farben Microarrays.
Laufzeit: 19.02.2008 – 31.12.2011
Förderer: BMBF
Publikationen:
Schiffl und R.D. Hilgers. A-optimal designs for two-color microarray experiments for treatment-control and all-to-next contrasts. Commun. Stat., Simulation Comput. 41, No. 7, 1142-1151 (2012).
K. Schiffl und R.D. Hilgers. “Optimal designs for two-colour microarrays experiments for estimating interactions.” In A. Giovagnoli, A.C. Atkinson, and B. Torsney, editors, mODa 9 - Advances in model-oriented design and analysis, Seiten 197 - 204. Physica, Heidelberg, 2010.
European Multicentre Clinical Trial Under the Auspices of the "Retinologische Gesellschaft" Scleral Buckling versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment (SPR-Study)
Laufzeit: 01.01.2001 – 30.09.2005
Förderer: DFG + Friedrich Spicker Stiftung
Publikationen
Feltgen N, Heimann H, Hoerauf H, Walter P, Hilgers R-D, Heussen N. Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study (SPR Study): Risk-assessment of anatomical outcome.SPR Study report no. 7. Acta Ophthalmologica 2013 May;91(3):282-7.
Heussen N, Feltgen N, Walter P, Hoerauf H, Hilgers RD, Heimann H; The SPR Study Group. Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study (SPR Study): predictive factors for functional outcome. Study report no. 6. Graefes Arch Clin Exp Ophthalmol. 2011 Aug;249(9):604-611.
Heimann H, Bornfeld N, Bartz-Schmidt UK, Hilgers RD, Heussen N. [Anaylsis of the surgeon factor in the treatment results of rhegmatogenous retinal detachment in the "scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study"]. Klin Monbl Augenheilkd. 2009 Dec;226(12):991-8.
Heussen N, Hilgers RD, Heimann H, Collins L, Grisanti S; for the SPR study group*. Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study (SPR Study): Multiple-event analysis of risk factors for reoperations. SPR Study report no. 4. Acta Ophthalmol. 2011 Nov;8(7):622-628.
Heimann H, Bartz-Schmidt KU, Bornfeld N, Weiss C, Hilgers RD & Foerster MH (2007): Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment: a prospective randomized multicenter clinical study. Ophthalmology 114: 2142–2154.
Feltgen N, Weiss C, Wolf S, Ottenberg D & Heimann H (2007): Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study (SPR Study): recruitment list evaluation. Study report no. 2. Graefe’s Arch Clin Exp Ophthalmol 245:803–809.
Heimann H, Hellmich M, Bornfeld N, Bartz-Schmidt KU, Hilgers RD & Foerster MH (2001): Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment (SPR Study): design issues and implications. SPR Study report no. 1. Graefe’s Arch Clin Exp Ophthalmol 239: 567–574.
Stop IgAN – Supportive versus Immunosuppressive Therapy for the treatment of Progressive IgA Nephropathy
IgA nephropathy (IgAN) is the most common type of glomerulonephritis (GN) in the Western world and is an important cause of renal failure. Despite its comparatively high prevalence the treatment of IgAN is a controversial issue.
While immunosupressive therapy has been shown to be effective, a similar effect can be achieved with a supportive (e.g. antiproteinuric and antihypertensive) therapy. All randomised controlled clinical trials with an immunosuppressive medication have an insufficient supportive therapy judged by today’s recommendation. Hence, it is unclear whether an additional immunosuppressive therapy added to the optimal supportive treatment might be effective in preserving renal function or whether the risk-benefit analysis remains positive in this case.
Against this background the present investigator inintiated, prospective, randomised clinical trial has been applied for the BMBF/DFG-programme "clinical trials". The recruitment of the STOP IgAN Study was started in 2008.
Duration: 19.02.2008 – 28.02.2015 (first patient in, last patient out)
F. Eitner, D. Ackermann, R. D. Hilgers und J. Floege: STOP IgAN trial (Supportive versus immunosuppressive therapy of progressive IgA nephropathy): rationale and study protocol. Journal of Nephrology 21: 284-289, 2008
F. Eitner, D. Ackermann, R. D. Hilgers und J. Floege: IgA-Nephropathie - Supportive versus immunosuppressive Therapie (STOP-IgAN). Nephrologe 3: 315–318, 2008
Rauen T, Eitner F., Fitzner C et al.: Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. The New England journal of medicine: 373 2225-36, 2015
Im Forschungsprojekt „TemRas“ (Telemedizinisches Rettungsassistenzsystem) wird Rettungsteams vor Ort die volle notärztliche Unterstützung durch ein allumfassendes Telemedizinsystem zur Verfügung gestellt.
Laufzeit: 01.08.2010 – 31.07.2013
Förderer: Ministerium für Wirtschaft, Energie, Industrie, Mittelstand und Handwerk des Landes Nordrhein-Westfalen
Joussen AM, Weiss C., Bauer D., Kirchhof B., Hilgers RD on behalf of the TIME Study Group: Triamcinolone versus Inner-Limiting Membrane Peeling in Diabetic Macular Edema (TIME Study): Design issues and implications. Graefe's Archive for Clinical and Experimental Ophthalmology 2007, 245:1781-1787.
