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2. Assessment of retinopathy of prematurity regression and reactivation using an artificial intelligence–based vascular severity score

Author

Eilts, Sonja K., Pfeil, Johanna M., Poschkamp, Broder, Krohne, Tim U., Eter, Nicole, Barth, Teresa, Guthoff, Rainer, Lagrèze, Wolf, Grundel, Milena, Bründer, Marie-Christine, Busch, Martin, Kalpathy-Cramer, Jayashree, Chiang, Michael F., Chan, R. V. Paul, Coyner, Aaron S., Ostmo, Susan, Campbell, J. Peter, Stahl, Andreas, Pfeil, Johanna M, Bühler, Anima, Daniel, Moritz, Felzmann, Susanne, Gross, Nicolai, Horn, Stefanie, Lagrèze, Wolf A, Molnár, Fanni, Müller, Claudia, Reichl, Sabine, Reiff, Charlotte, Richter, Olga, Stech, Milena, Hentschel, Roland, Stavropolou, Dimitria, Tautz, Juliane, Bartsch, Kerstin, Braunstein, Jennifer, Brinken, Ralf, Brinkmann, Christian Karl, Czauderna, Joanna, Dralle, Wiebke, Gliem, Martin, Goebel, Arno, Heymer, Philipp, Hofmann, Martina, Holz, Frank G, Krohne, Tim U, Kupitz, David, Müller, Philipp, Petrak, Michael, Schmitz, Eva Janine, Schmitz-Valckenberg, Steffen, Schröder, Moritz, Steinberg, Julia, Supé, Julia, Kant, Evelyn, Kunze, Diana, Müller, Andreas, Adorf, Adeline, Alex, Anne, Alten, Florian, Clemens, Christoph R, Falkenau, Silvia, Friedhoff, Caroline, Loos, Desiree Sandra, Mihailovic, Natasa, Termühlen, Julia, Uhlig, Constantin, Hörnig-Franz, Isabell, Rieger-Fackeldey, Esther, Tekaat, Maria, Werner, Claudius, Altmann, Mathias, Blecha, Christiane, Brandl-Rühle, Sabine, Helbig, Horst, Hufendiek, Karsten, Jägle, Herbert, Konrad, Julia, Kopetzky, Eva, Lehmann, Fabian, Oberacher-Velten, Isabel, Keller-Wackerbauer, Annette, Kittel, Jochen, Segerer, Hugo, Ackermann, Phillip, Benga, Jemina, Guthoff, Tanja, Kleinert, Elena, Mayatepek, Ertan, Schrader, Stefan, Völker, Magdalena, Höhn, Thomas, Lohmeier, Klaus, Sabir, Hemmen, Brevis, Francisco, Mönig, Tina, Schwarz, Simone, Ehmer, Angela, Meltendorf, Synke, Schuart, Claudia, Avenarius, Stefan, Böttger, Ralf, Apel, Christoph, Bergmann, Anne, Herrmann, Karsten, Ockert-Schön, Franziska, Wegener, Sabine, Ehrt, Oliver, Nentwich, Martin, Pressler, Angelika, Rudolph, Günther, Genzel-Boroviczeny, Orsolya, Schmidt, Susanne, Münch, Hans-Georg, Thilmany, Claude, Aisenbrey, Sabine, Bruckmann, Anna, Dimopoulos, Spyridon, Hagemann, Ulrike, Inhoffen, Werner, Partsch, Michael, Schrader, Merle, Süsskind, Daniela, Völker, Michael, Bialkowski, Anja, Müller-Hansen, Ingo, Gerberth, Andrea, Hasselbach, Heike Christine, Lindemann, Solveig, Purtskhvanidze, Konstantine, Raffel, Yvonne, Roider, Johann, Schröder, Greta, Szymanek, Beke, Tode, Jan, Bendiks, Meike, Modlich, Simon, Jandeck, Isabel, Gerding, Heinrich, Smith, Lois E H, Eilts, Sonja K., Pfeil, Johanna M., Poschkamp, Broder, Krohne, Tim U., Eter, Nicole, Barth, Teresa, Guthoff, Rainer, Lagrèze, Wolf, Grundel, Milena, Bründer, Marie-Christine, Busch, Martin, Kalpathy-Cramer, Jayashree, Chiang, Michael F., Chan, R. V. Paul, Coyner, Aaron S., Ostmo, Susan, Campbell, J. Peter, Stahl, Andreas, Pfeil, Johanna M, Bühler, Anima, Daniel, Moritz, Felzmann, Susanne, Gross, Nicolai, Horn, Stefanie, Lagrèze, Wolf A, Molnár, Fanni, Müller, Claudia, Reichl, Sabine, Reiff, Charlotte, Richter, Olga, Stech, Milena, Hentschel, Roland, Stavropolou, Dimitria, Tautz, Juliane, Bartsch, Kerstin, Braunstein, Jennifer, Brinken, Ralf, Brinkmann, Christian Karl, Czauderna, Joanna, Dralle, Wiebke, Gliem, Martin, Goebel, Arno, Heymer, Philipp, Hofmann, Martina, Holz, Frank G, Krohne, Tim U, Kupitz, David, Müller, Philipp, Petrak, Michael, Schmitz, Eva Janine, Schmitz-Valckenberg, Steffen, Schröder, Moritz, Steinberg, Julia, Supé, Julia, Kant, Evelyn, Kunze, Diana, Müller, Andreas, Adorf, Adeline, Alex, Anne, Alten, Florian, Clemens, Christoph R, Falkenau, Silvia, Friedhoff, Caroline, Loos, Desiree Sandra, Mihailovic, Natasa, Termühlen, Julia, Uhlig, Constantin, Hörnig-Franz, Isabell, Rieger-Fackeldey, Esther, Tekaat, Maria, Werner, Claudius, Altmann, Mathias, Blecha, Christiane, Brandl-Rühle, Sabine, Helbig, Horst, Hufendiek, Karsten, Jägle, Herbert, Konrad, Julia, Kopetzky, Eva, Lehmann, Fabian, Oberacher-Velten, Isabel, Keller-Wackerbauer, Annette, Kittel, Jochen, Segerer, Hugo, Ackermann, Phillip, Benga, Jemina, Guthoff, Tanja, Kleinert, Elena, Mayatepek, Ertan, Schrader, Stefan, Völker, Magdalena, Höhn, Thomas, Lohmeier, Klaus, Sabir, Hemmen, Brevis, Francisco, Mönig, Tina, Schwarz, Simone, Ehmer, Angela, Meltendorf, Synke, Schuart, Claudia, Avenarius, Stefan, Böttger, Ralf, Apel, Christoph, Bergmann, Anne, Herrmann, Karsten, Ockert-Schön, Franziska, Wegener, Sabine, Ehrt, Oliver, Nentwich, Martin, Pressler, Angelika, Rudolph, Günther, Genzel-Boroviczeny, Orsolya, Schmidt, Susanne, Münch, Hans-Georg, Thilmany, Claude, Aisenbrey, Sabine, Bruckmann, Anna, Dimopoulos, Spyridon, Hagemann, Ulrike, Inhoffen, Werner, Partsch, Michael, Schrader, Merle, Süsskind, Daniela, Völker, Michael, Bialkowski, Anja, Müller-Hansen, Ingo, Gerberth, Andrea, Hasselbach, Heike Christine, Lindemann, Solveig, Purtskhvanidze, Konstantine, Raffel, Yvonne, Roider, Johann, Schröder, Greta, Szymanek, Beke, Tode, Jan, Bendiks, Meike, Modlich, Simon, Jandeck, Isabel, Gerding, Heinrich, and Smith, Lois E H

Published
2023

3. Zusammenarbeit mit klinischen Auftragsforschungsinstituten

Author

Adorf, Adeline, Lorenz, Katrin, Feltgen, Nicolas, and Wilhelm, Barbara

Abstract

Klinische Studien mit Arzneimitteln oder Medizinprodukten stellen zunehmend komplexe Anforderungen an Sponsoren und beteiligte Zentren. In den letzten 2 Jahrzehnten delegieren Sponsoren regulatorische sowie organisatorische Studienaufgaben zunehmend an medizinische Auftragsinstitute (engl. Clinical Research Organisation [CRO]). In der Regel sind diese Unternehmen die Hauptschnittstelle für die Zusammenarbeit mit den beteiligten Studienzentren. Hauptzweck der Mitwirkung ist die Unterstützung der Studienzentren zur Erzielung einer maximalen Studienqualität. Die in der Arbeitsgemeinschaft DOG Klinische Studienzentren verbundenen Studienzentren beobachten unterschiedliche Erfahrungen in der Zusammenarbeit mit CROs. Solche Erfahrungen sollen künftig systematisch an den beteiligten Zentren erfasst und vom Leiter der klinischen Studie ausgewertet werden. Die Spiegelung dieser Erfahrungen an die jeweiligen Auftragsinstitute und die sie beauftragenden Sponsoren kann in der Zukunft zur Qualität der Unterstützung durch CROs und damit zur Studienqualität beitragen. Die vorliegende Arbeit stellt vor, welche Bereiche der Zusammenarbeit im Fragebogen erfasst und analysiert werden.

Published
2024
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4. Visual impairment and blindness in institutionalized elderly in Germany

Author

Larsen, Petra P., Thiele, Sarah, Krohne, Tim U., Ziemssen, Focke, Krummenauer, Frank, Holz, Frank G., Finger, Robert P., Kohnen, Thomas, Naycheva, Lubka, Jochem, Maximilian, Reinhard, Thomas, Boehringer, Daniel, Engesser, Diana, Lagreze, Wolf, Mueller, Claudia, Wolff, Carolin, Schmitz, Jessica, Lorenz, Birgit, Papadopoulou-Laiou, Chrysanthi, Holve, Kerstin, Schweinfurth, Silke, Hoerauf, Hans, Schwarz, Wiebke, Spitzer, Martin, Wagenfeld, Lars, Bertram, Paul, Auffarth, Gerd, Gavrilovic, Branka, Cursiefen, Claus, Schaub, Friederike, Lentzsch, Anna, Welsandt, Gerhard, Thieme, Hagen, Weigel, Melanie, Hidaya, Diyala, Ehmer, Angela, Priglinger, Siegfried, von Livonius, Bettina, Drexler, Carina, Semmelsberger, Jessica, Eter, Nicole, Alten, Florian, Sigleur, Annika, Sieber, Dorothee, Braeutigam, Andrea, Haerter, Friederike, Adorf, Adeline, Pauleikhoff, Daniel, Robering, Angela, Helbig, Horst, Brandl, Caroline, Roeck, Daniel, Tulka, Sabrina, Wabbels, Bettina, Kupitz, David. G., Goebel, Arno P., Steinberg, Julia, Schnetzer, Anne, Kobialka, Bianka, Prinz, Beate, Kutten, Danielle, Schneider, Pia, Toczko, Olivia, Yoganathan, Thanushiya, Larsen, Petra P., Thiele, Sarah, Krohne, Tim U., Ziemssen, Focke, Krummenauer, Frank, Holz, Frank G., Finger, Robert P., Kohnen, Thomas, Naycheva, Lubka, Jochem, Maximilian, Reinhard, Thomas, Boehringer, Daniel, Engesser, Diana, Lagreze, Wolf, Mueller, Claudia, Wolff, Carolin, Schmitz, Jessica, Lorenz, Birgit, Papadopoulou-Laiou, Chrysanthi, Holve, Kerstin, Schweinfurth, Silke, Hoerauf, Hans, Schwarz, Wiebke, Spitzer, Martin, Wagenfeld, Lars, Bertram, Paul, Auffarth, Gerd, Gavrilovic, Branka, Cursiefen, Claus, Schaub, Friederike, Lentzsch, Anna, Welsandt, Gerhard, Thieme, Hagen, Weigel, Melanie, Hidaya, Diyala, Ehmer, Angela, Priglinger, Siegfried, von Livonius, Bettina, Drexler, Carina, Semmelsberger, Jessica, Eter, Nicole, Alten, Florian, Sigleur, Annika, Sieber, Dorothee, Braeutigam, Andrea, Haerter, Friederike, Adorf, Adeline, Pauleikhoff, Daniel, Robering, Angela, Helbig, Horst, Brandl, Caroline, Roeck, Daniel, Tulka, Sabrina, Wabbels, Bettina, Kupitz, David. G., Goebel, Arno P., Steinberg, Julia, Schnetzer, Anne, Kobialka, Bianka, Prinz, Beate, Kutten, Danielle, Schneider, Pia, Toczko, Olivia, and Yoganathan, Thanushiya

Abstract

PurposeTo determine the prevalence of and identify factors associated with visual impairment and blindness in institutionalized elderly in Germany.MethodsIn this prospective multicenter cross-sectional study, ophthalmic health care need and provision were investigated in institutionalized elderly in 32 nursing homes in Germany. All participants underwent a standardized examination including medical and ocular history, refraction, visual acuity testing, tonometry, biomicroscopy, and dilated funduscopy. A standardized questionnaire was used to identify factors associated with eye healthcare utilization, visual impairment and/or blindness.ResultsVisual acuity of 566 (94.3%; 413 women and 153 men) of a total of 600 institutionalized elderly was determined. Mean age of the included patients was 82.9years (9.8). Of all participants, 30 (5.3%; 95% CI 3.4-7.2%) were blind and 106 (18.7%; 95% CI 15.5-21.9%) were moderately or severely visually impaired according to the World Health Organization definition. The 136 blind and moderately or severely visually impaired participants were older (OR, Odds Ratio=1.1, 95% CI 1.0-1.1; p<0.001), and more likely to have reduced mobility (OR=12.6, 95% CI 2.8-57.6; p=0.001).Conclusion p id=Par4 A high proportion of blindness and visual impairment was found amongst nursing home residents. Age and reduced mobility were factors associated with an increased likelihood of blindness and visual impairment. Any surveys of blindness and visual impairment excluding nursing homes may considerably underestimate the prevalence of visual impairment and blindness.

Published
2019

5. Comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity : a randomized clinical trial

Author

Stahl, Andreas, Krohne, Tim U., Eter, Nicole, Oberacher-Velten, Isabel, Guthoff, Rainer, Meltendorf, Synke, Ehrt, Oliver, Aisenbrey, Sabine, Roider, Johann, Gerding, Heinrich, Jandeck, Claudia, Smith, Lois E. H., Walz, Johanna M., Bühler, Anima, Daniel, Moritz, Felzmann, Susanne, Gross, Nicolai, Horn, Stefanie, Lagrèze, Wolf, Molnár, Fanni, Müller, Claudia, Reichl, Sabine, Reiff, Charlotte, Richter, Olga, Stech, Milena, Hentschel, Roland, Stavropolou, Dimitria, Tautz, Juliane, Bartsch, Kerstin, Braunstein, Jennifer, Brinken, Ralf, Brinkmann, Christian Karl, Czauderna, Joanna, Dralle, Wiebke, Gliem, Martin, Goebel, Arno, Heymer, Philipp, Hofmann, Martina, Holz, Frank G., Kupitz, David, Müller, Philipp, Petrak, Michael, Schmitz, Eva Janine, Schmitz-Valckenberg, Steffen, Schröder, Moritz, Steinberg, Julia, Supé, Julia, Kant, Evelyn, Kunze, Diana, Müller, Andreas, Adorf, Adeline, Alex, Anne, Alten, Florian, Clemens, Christoph R., Falkenau, Silvia, Friedhoff, Caroline, Loos, Desiree Sandra, Mihailovic, Natasa, Termühlen, Julia, Uhlig, Constantin, Hörnig-Franz, Isabell, Rieger-Fackeldey, Esther, Tekaat, Maria, Werner, Claudius, Altmann, Mathias, Barth, Theresa, Blecha, Christiane, Brandl-Rühle, Sabine, Helbig, Horst, Hufendiek, Karsten, Jägle, Herbert, Konrad, Julia, Kopetzky, Eva, Lehmann, Fabian, Keller-Wackerbauer, Annette, Kittel, Jochen, Segerer, Hugo, Ackermann, Phillip, Benga, Jemina, Guthoff, Tanja, Kleinert, Elena, Mayatepek, Ertan, Schrader, Stefan, Völker, Magdalena, Höhn, Thomas, Lohmeier, Klaus, Sabir, Hemmen, Brevis, Francisco, Mönig, Tina, Schwarz, Simone, Ehmer, Angela, Schuart, Claudia, Avenarius, Stefan, Böttger, Ralf, Apel, Christoph, Bergmann, Anne, Herrmann, Karsten, Ockert-Schön, Franziska, Wegener, Sabine, Nentwich, Martin, Pressler, Angelika, Rudolph, Günther, Genzel-Boroviczeny, Orsolya, Schmidt, Susanne, Münch, Hans-Georg, Thilmany, Claude, Bruckmann, Anna, Dimopoulos, Spyridon, Hagemann, Ulrike, Inhoffen, Werner, Partsch, Michael, Schrader, Merle, Süsskind, Daniela, Völker, Michael, Bialkowski, Anja, Müller-Hansen, Ingo, Gerberth, Andrea, Hasselbach, Heike Christine, Lindemann, Solveig, Purtskhvanidze, Konstantine, Raffel, Yvonne, Schröder, Greta, Szymanek, Beke, Tode, Jan, Bendiks, Meike, and Modlich, Simon

Subjects
Male, Vascular Endothelial Growth Factor A, medicine.medical_specialty, genetic structures, Bevacizumab, Medizin, Angiogenesis Inhibitors, Pilot Projects, law.invention, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Germany, Ranibizumab, Internal medicine, Clinical endpoint, Humans, Medicine, Retinopathy of Prematurity, Dosing, Original Investigation, Dose-Response Relationship, Drug, business.industry, Standard treatment, Infant, Newborn, Retinopathy of prematurity, Odds ratio, medicine.disease, Treatment Outcome, Pediatrics, Perinatology and Child Health, 030221 ophthalmology & optometry, Female, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Importance Anti–vascular endothelial growth factor (VEGF) therapies are a novel treatment option in retinopathy of prematurity (ROP). Data on dosing, efficacy, and safety are insufficient. Objective To investigate lower doses of anti-VEGF therapy with ranibizumab, a substance with a significantly shorter systemic half-life than the standard treatment, bevacizumab. Design, Setting, and Participants This randomized, multicenter, double-blind, investigator-initiated trial at 9 academic medical centers in Germany compared ranibizumab doses of 0.12 mg vs 0.20 mg in infants with bilateral aggressive posterior ROP; ROP stage 1 with plus disease, 2 with plus disease, or 3 with or without plus disease in zone I; or ROP stage 3 with plus disease in posterior zone II. Patients were recruited between September 2014 and August 2016. Twenty infants were screened and 19 were randomized. Interventions All infants received 1 baseline ranibizumab injection per eye. Reinjections were allowed in case of ROP recurrence after at least 28 days. Main Outcomes and Measures The primary end point was the number of infants who did not require rescue therapy at 24 weeks. Key secondary end points included time-to-event analyses, progression of physiologic vascularization, and plasma VEGF levels. Stages of ROP were photodocumented and reviewed by an expert committee. Results Nineteen infants with ROP were enrolled (9 [47.4%] female; median [range] postmenstrual age at first treatment, 36.4 [34.7-39.7] weeks), 3 of whom died during the study (1 in the 0.12-mg group and 2 in the 0.20-mg group). Of the surviving infants, 8 (88.9%) (17 eyes [94.4%]) in the 0.12-mg group and 6 (85.7%) (13 eyes [92.9%]) in the 0.20-mg group did not require rescue therapy. Both ranibizumab doses were equally successful in controlling acute ROP (Cochran-Mantel-Haenszel analysis; odds ratio, 1.88; 95% CI, 0.26-13.49;P = .53). Physiologic intraretinal vascularization was superior in the 0.12-mg group. The VEGF plasma levels were not systematically altered in either group. Conclusions and Relevance This pilot study demonstrates that ranibizumab is effective in controlling acute ROP and that 24% of the standard adult dose (0.12 mg) appears equally effective as 40% (0.20 mg). Superior vascularization of the peripheral retina with 0.12 mg of ranibizumab indicates that the lower dose may be favorable. Unchanged plasma VEGF levels point toward a limited systemic drug exposure after ranibizumab. Trial Registration clinicaltrials.gov Identifier:NCT02134457and clinicaltrialsregister.eu Identifier:2013-002539-13.

Published
2018

6. [Collaboration with clinical research organizations : Introduction of a questionnaire for clinical study centers].

Author

Adorf A, Lorenz K, Feltgen N, and Wilhelm B

Subjects
Surveys and Questionnaires, Organizations
Abstract

Clinical trials with pharmaceuticals or medical devices make complex demands on sponsors and participating centers. During the past two decades, sponsors have increasingly delegated regulatory and organizational tasks to clinical research organizations (CRO). As a rule, these companies are the main interface for the collaboration with the participating study centers. The main purpose of the participation is the support of the study centers for achieving an optimal study quality. The study centers involved in the DOG working group on clinical study centers perceived varying experiences in the collaboration with CROs. In the future these experiences will be systematically assessed at the participating study centers and analyzed by the coordinating investigator. Reflecting these experiences to the respective CROs and the delegating sponsors will contribute to the quality of support by CROs and herewith to the quality of clinical trials. This paper presents which areas of collaboration will be assessed and analyzed., (© 2021. The Author(s).)

Published
2022
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