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1. Treated Cases of Retinopathy of Prematurity in Germany

Author

Pfeil, Johanna M., Barth, Teresa, Lagrèze, Wolf A., Lorenz, Birgit, Hufendiek, Karsten, Liegl, Raffael, Breuss, Helge, Bemme, Sebastian, Aisenbrey, Sabine, Glitz, Barbara, Süsskind, Daniela, Gabel-Pfisterer, Ameli, Skevas, Christos, Krohne, Tim U., Kakkassery, Vinodh, Bründer, Marie-Christine, Engelmann, Katrin, Guthoff, Rainer, Walter, Peter, Choritz, Lars, Stahl, Andreas, Michalewicz, Emilia, Baumgarten, Sabine, Lohmann, Tibor, Walter, Peter, Breuß, Helge, Retzlaff, Annekatrin, Bödemann, Melanie, Liegl, Marian, El Moussaoui, Laila, Aisenbrey, Sabine, Saßmannshausen, Marlene, Liegl, Raffael, Engelmann, Katrin, Goldammer, Imke, Fleischer, Ulrike, Ander, Annika, Tietz, Martin, Wienigk, Anja, Li, Jeany Q., Krohne, Tim U., Guthoff, Rainer, Khamees, Ala, Kaya, Sema, Höhn, Thomas, Lohmeier, Klaus, Franzel, Julia, Busik, Valentina, Mais, Christine, Bemme, Sebastian, Khattab, Mohammed, Lauermann, Peer, Meyer, Yulia, Dieks, Jana Katharina, Bründer, Marie-Christine, Grundel, Bastian, Grundel, Milena, Paul, Sebastian, Stahl, Andreas, Tayar, Allam, Heckmann, Matthias, Bahlmann, Hagen, Linnemann, Knud, Skevas, Christos, Hagenau, Felix, Spitzer, Martin, Herden, Jonas, Gröber, Thomas, Haar, Melanie, Mester, Nils, Brockmann, Dorothee, Tode, Jan, Hufendiek, Karsten, Framme, Carsten, Bohnhorst, Bettina, Böhne, Carolin, Peter, Corinna, Pirr, Sabine, Brosig, Anton, Gniesmer, Stefanie, Grisanti, Salvatore, Lüken, Sabine, Piria, Roya, Prasuhn, Michelle, Ranjbar, Mahdy, Rommel, Felix, Schiemenz, Christian, Kakkassery, Vinodh, Heckert, Anni, Choritz, Lars, Glitz, Barbara, Eter, Nicole, Falkenau, Silvia, Gabel-Pfisterer, Ameli, Lindenberg, Ann-Sophie, Mathias, Altmann, Barth, Teresa, Benedikt, Blüml, Isabel, Oberacher-Velten, Patrick, Peters, Herbert, Jägle, Horst, Helbig, Stephan, Döring, Anette, Keller-Wackerbauer, Jochen, Kittel, Holger, Michel, Hugo, Segerer, Sven, Wellmann, Süsskind, Daniela, Partsch, Michael, Völker, Michael, and Hagemann, Ulrike

Abstract

To analyze changes in demographic parameters and retreatment patterns over a 10-year period in a clinical routine setting of infants with retinopathy of prematurity (ROP) requiring treatment documented in the German Retina.net ROP registry.

Published
2024
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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. Retinal vascular occlusion after COVID-19 vaccination: more coincidence than causal relationship? Data from a retrospective multicentre study

Author

Feltgen, Nicolas, Ach, Thomas, Ziemssen, Focke, Quante, Carolin Sophie, Gross, Oliver, Abdin, Alaa Din, Aisenbrey, Sabine, Bartram, Martin C., Blum, Marcus, Brockmann, Claudia, Dithmar, Stefan, Friedrichs, Wilko, Guthoff, Rainer, Hattenbach, Lars-Olof, Herrlinger, Klaus R., Kaskel-Paul, Susanne, Khoramnia, Ramin, Klaas, Julian E., Krohne, Tim U., Lommatzsch, Albrecht, Lueken, Sabine, Maier, Mathias, Nassri, Lina, Nguyen-Dang, Thien A., Radeck, Viola, Rau, Saskia, Roider, Johann, Sandner, Dirk, Schmalenberger, Laura, Schmidtmann, Irene, Schubert, Florian, Siegel, Helena, Spitzer, Martin S., Stahl, Andreas, Stingl, Julia V., Treumer, Felix, Viestenz, Arne, Wachtlin, Joachim, Wolf, Armin, Zimmermann, Julian, Schargus, Marc, Schuster, Alexander K., and Ascaso, Francisco Javier

Subjects
SARS-CoV-2, Optic neuropathy, Ischemic, anterior ischaemic optic neuropathy, COVID-19, Auge, retinal artery occlusion, vaccination, infection, Retinal vein occlusion, Arterienverschluss, COVID-19 vaccines, Adverse effects, Impfung, ddc:610, Risk assessment
Published
2022

5. Retinal Vascular Occlusion after COVID-19 Vaccination: More Coincidence than Causal Relationship? Data from a Retrospective Multicentre Study

Author

Feltgen, Nicolas, primary, Ach, Thomas, additional, Ziemssen, Focke, additional, Quante, Carolin Sophie, additional, Gross, Oliver, additional, Abdin, Alaa Din, additional, Aisenbrey, Sabine, additional, Bartram, Martin C., additional, Blum, Marcus, additional, Brockmann, Claudia, additional, Dithmar, Stefan, additional, Friedrichs, Wilko, additional, Guthoff, Rainer, additional, Hattenbach, Lars-Olof, additional, Herrlinger, Klaus R., additional, Kaskel-Paul, Susanne, additional, Khoramnia, Ramin, additional, Klaas, Julian E., additional, Krohne, Tim U., additional, Lommatzsch, Albrecht, additional, Lueken, Sabine, additional, Maier, Mathias, additional, Nassri, Lina, additional, Nguyen-Dang, Thien A., additional, Radeck, Viola, additional, Rau, Saskia, additional, Roider, Johann, additional, Sandner, Dirk, additional, Schmalenberger, Laura, additional, Schmidtmann, Irene, additional, Schubert, Florian, additional, Siegel, Helena, additional, Spitzer, Martin S., additional, Stahl, Andreas, additional, Stingl, Julia V., additional, Treumer, Felix, additional, Viestenz, Arne, additional, Wachtlin, Joachim, additional, Wolf, Armin, additional, Zimmermann, Julian, additional, Schargus, Marc, additional, and Schuster, Alexander K., additional

Published
2022
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6. Teilnahme an einer klinischen Studie – Ist das etwas für mich?: Videobeitrag.

Author

Lorenz, Katrin, Böhringer, Daniel, Wilhelm, Barbara, Arbeitsgemeinschaft DOG Klinische Studienzentren, Aisenbrey, Sabine, Allgeier, Katharina, Baur, Isabella, Bertelmann, Eckart, Brinkmann, Christian Karl, Choritz, Lars, Deuter, Christoph, Ehlken, Christoph, Eter, Nicole, Feltgen, Nicolas, Fleckenstein, Monika, Fornoff, Luise, Fuchsluger, Thomas Armin, Gamulescu, Maria-Andreea, Goos, Daniela, and Heinz, Carsten

Abstract

Copyright of Die Ophthalmologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2023
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7. High-Throughput Sequencing to Identify Mutations Associated with Retinal Dystrophies

Author

Song, Fei, Owczarek-Lipska, Marta, Ahmels, Tim, Book, Marius, Aisenbrey, Sabine, Menghini, Moreno, Barthelmes, Daniel, Schrader, Stefan, Spital, Georg, Neidhardt, John, University of Zurich, and Neidhardt, John

Subjects
10018 Ophthalmology Clinic, Male, 2716 Genetics (clinical), Sanger sequencing, Genotype, 610 Medicine & health, Genetic Counseling, QH426-470, Article, whole exome sequencing, 1311 Genetics, deep-intronic variants, Retinal Dystrophies, Exome Sequencing, Genetics, Humans, Exome, Genetic Predisposition to Disease, retinal dystrophy, Genetic Association Studies, High-Throughput Nucleotide Sequencing, Sequence Analysis, DNA, Middle Aged, mutations, Pedigree, novel variant, Phenotype, Mutation, ATP-Binding Cassette Transporters, Female
Abstract

Retinal dystrophies (RD) are clinically and genetically heterogenous disorders showing mutations in over 270 disease-associated genes. Several millions of people worldwide are affected with different types of RD. Studying the relevance of disease-associated sequence alterations will assist in understanding disorders and may lead to the development of therapeutic approaches. Here, we established a whole exome sequencing (WES) pipeline to rapidly identify disease-associated mutations in patients. Sanger sequencing was applied to identify deep-intronic variants and to verify the co-segregation of WES results within families. We analyzed 26 unrelated patients with different syndromic and non-syndromic clinical manifestations of RD. All patients underwent ophthalmic examinations. We identified nine novel disease-associated sequence variants among 37 variants identified in total. The sequence variants located to 17 different genes. Interestingly, two cases presenting with Stargardt disease carried deep-intronic variants in ABCA4. We have classified 21 variants as pathogenic variants, 4 as benign/likely benign variants, and 12 as variants of uncertain significance. This study highlights the importance of WES-based mutation analyses in RD patients supporting clinical decisions, broadly based genetic diagnosis and support genetic counselling. It is essential for any genetic therapy to expand the mutation spectrum, understand the genes’ function, and correlate phenotypes with genotypes.

Published
2021

8. 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

12. The German ROP Registry: data from 90 infants treated for retinopathy of prematurity.

Author

Walz, Johanna M., Bemme, Sebastian, Pielen, Amelie, Aisenbrey, Sabine, Breuß, Helge, Alex, Anne F., Wagenfeld, Lars, Schiedel, Susanne, Krohne, Tim U., Stahl, Andreas, Akman, Stella H., Bajor, Anna, Biermann, Julia, Bohnhorst, Bettina, Brockmann, Dorothee, Diehl, Thilo Alexander, Eter, Nicole, Feltgen, Nicolas, Framme, Carsten, and Gesser, Caroline

Subjects
RETROLENTAL fibroplasia, EPIDEMIOLOGY, OPHTHALMOLOGY, LASER therapy, VASCULAR endothelial growth factors, THERAPEUTICS
Abstract

Purpose The German retinopathy of prematurity ( ROP) Registry collects data on treated ROP in a multicentre approach to analyse epidemiology and treatment patterns of severe ROP. Methods Nine centres entered data from 90 treated ROP infants (born between January 2011 and December 2013) into a central database. Analysis included incidence rate of severe ROP, demographic data, stage of ROP, treatment patterns, recurrence rates, relevant comorbidities and ophthalmological or systemic complications associated with treatment. Results Treatment rate for ROP was 3.2% of the screened population. The most frequent ROP stage at time of treatment was zone II, stage 3 + (137 eyes). Treatment was bilateral in 97% of infants. Treatment patterns changed over time from 7% anti-vascular endothelial growth factor (VEGF) monotherapy in 2011 to 32% in 2014. Overall, laser treatment was the predominant treatment. However, all infants with zone I disease received anti- VEGF treatment. About 19% of infants required retreatment (16% of laser-treated and 21% of anti- VEGF treated infants). Mean time between first and second treatment was 3.8 weeks (± 11 days) for laser-treated and 10.4 weeks (± 60 days) for anti- VEGF-treated infants. Conclusion This study is the first multicentre analysis of severe ROP in Germany. The identified treatment patterns find laser as the most prevalent form of therapy, with an increasing use of anti- VEGF therapy over recent years. Recurrence rates were relatively high overall with slightly higher recurrence rates and later recurrence times in the anti- VEGF group. Anti- VEGF was predominantly used for high-risk stages like AP- ROP and zone I disease. [ABSTRACT FROM AUTHOR]

Published
2016
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13. Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity: A Randomized Clinical Trial.

Author

Stahl A, Krohne TU, Eter N, Oberacher-Velten I, Guthoff R, Meltendorf S, Ehrt O, Aisenbrey S, Roider J, Gerding H, Jandeck C, Smith LEH, and Walz JM

Subjects
Bevacizumab administration & dosage, Dose-Response Relationship, Drug, Double-Blind Method, Female, Germany, Humans, Infant, Newborn, Male, Pilot Projects, Treatment Outcome, Vascular Endothelial Growth Factor A blood, Angiogenesis Inhibitors administration & dosage, Ranibizumab administration & dosage, Retinopathy of Prematurity drug therapy
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: NCT02134457 and clinicaltrialsregister.eu Identifier: 2013-002539-13.

Published
2018
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