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5. 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

10. 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

11. Survival and functionality of xeno‐free human embryonic stem cell–derived retinal pigment epithelial cells on polyester substrate after transplantation in rabbits

Author

Ilmarinen, Tanja, primary, Thieltges, Fabian, additional, Hongisto, Heidi, additional, Juuti‐Uusitalo, Kati, additional, Koistinen, Arto, additional, Kaarniranta, Kai, additional, Brinken, Ralf, additional, Braun, Norbert, additional, Holz, Frank G., additional, Skottman, Heli, additional, and Stanzel, Boris V., additional

Published
2018
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12. Survival and functionality of xeno‐free human embryonic stem cell–derived retinal pigment epithelial cells on polyester substrate after transplantation in rabbits.

Author

Ilmarinen, Tanja, Thieltges, Fabian, Hongisto, Heidi, Juuti‐Uusitalo, Kati, Koistinen, Arto, Kaarniranta, Kai, Brinken, Ralf, Braun, Norbert, Holz, Frank G., Skottman, Heli, and Stanzel, Boris V.

Subjects
RHODOPSIN, EPITHELIAL cells, BIOLOGICAL pigments, RABBITS, MAJOR histocompatibility complex
Abstract

Purpose: To study immunogenic properties of human embryonic stem cell–derived retinal pigment epithelium (hESC‐RPE) and to evaluate subretinal xenotransplantation of hESC‐RPE on porous polyethylene terephthalate (PET) in rabbits. Methods: Human ESC‐RPE cells were characterized by morphology, transepithelial electrical resistance (TER), protein expression and photoreceptor outer segment phagocytosis in vitro. Expression of major histocompatibility complex (MHC) proteins was assessed in conventionally or xeno‐free produced hESC‐RPE ± interferon‐gamma (IFN‐γ) stimulation (n = 1). Xeno‐free hESC‐RPE on PET with TER < 200 Ω·cm2 > or PET alone were transplanted into 18 rabbits with short‐term triamcinolone ± extended tacrolimus immunosuppression. Rabbits were monitored by spectral domain optical coherence tomography. After 4 weeks, the eyes were processed for histology and transmission electron microscopy. Results: Upon in vitro IFN‐γ stimulation, xeno‐free hESC‐RPE expressed lower level of MHC‐II proteins compared to the conventional cells. Outer nuclear layer (ONL) atrophy was observed over the graft in most cases 4 weeks post‐transplantation. In 3/4 animals with high TER hESC‐RPE, but only in 1/3 animals with low TER hESC‐RPE, ONL atrophy was observed already within 1 week. Retinal cell infiltrations were more frequent in animals with high TER hESC‐RPE. However, the difference was not statistically significant. In three animals, preservation of ONL was observed. Weekly intravitreal tacrolimus did not affect ONL preservation. In all animals, hESC‐RPE cells survived for 4 weeks, but without tacrolimus, enlarged vacuoles accumulated in hESC‐RPE (n = 1). Conclusions: Xenografted xeno‐free hESC‐RPE monolayers can survive and retain some functionality for 4 weeks following short‐term immunosuppression. The preliminary findings of this study suggest that further investigations to improve transplantation success of hESC‐RPE xenografts in rabbits should be addressed especially toward the roles of hESC‐RPE maturation stage and extended intravitreal immunosuppression. [ABSTRACT FROM AUTHOR]

Published
2019
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13. A Step by Step Protocol for Subretinal Surgery in Rabbits

Author

Al-Nawaiseh, Sami, primary, Thieltges, Fabian, primary, Liu, Zengping, primary, Strack, Claudine, primary, Brinken, Ralf, primary, Braun, Norbert, primary, Wolschendorf, Marc, primary, Maminishkis, Arvydas, primary, Eter, Nicole, primary, and Stanzel, Boris V., primary

Published
2016
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15. Human RPE Stem Cells Grown into Polarized RPE Monolayers on a Polyester Matrix Are Maintained after Grafting into Rabbit Subretinal Space

Author

Stanzel, Boris V., primary, Liu, Zengping, additional, Somboonthanakij, Sudawadee, additional, Wongsawad, Warapat, additional, Brinken, Ralf, additional, Eter, Nicole, additional, Corneo, Barbara, additional, Holz, Frank G., additional, Temple, Sally, additional, Stern, Jeffrey H., additional, and Blenkinsop, Timothy A., additional

Published
2014
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19. [The "Three Cherries Technique" for glaucoma drainage devices].

Author

Weber C, Brinken R, Holz FG, and Mercieca K

Subjects
Humans, Antimetabolites, Mitomycin, Glaucoma surgery, Filtering Surgery, Glaucoma Drainage Implants
Abstract

Small sponges are used to apply antimetabolites in order to reduce the risk of fibrosis in filtering glaucoma surgery. Due to the posterior location of the filtering bleb in glaucoma drainage implants, there is a risk that the sponges can dislocate in this area and cannot be retrieved after the exposure time has elapsed. We use the "three cherries technique" to minimize the risk. The term "three cherries technique" was coined by us and has not been used before in the literature. The three sponges that are used for mitomycin C application are each connected by single button sutures with a 7.0 vicryl thread. At the end of the application time, the sponges can be quickly removed by pulling the thread., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Published
2023
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20. [First clinical results with the PAUL® Glaucoma Implant at the University Eye Hospital Bonn].

Author

Weber C, Hundertmark S, Brinken R, Holz FG, and Mercieca K

Subjects
Humans, Hospitals, Glaucoma surgery, Glaucoma Drainage Implants
Abstract

Background: Glaucoma drainage devices (GDD) are an invasive procedure for the treatment of glaucoma. The PAUL® Glaucoma Implant (PGI) has been developed as a new, innovative therapeutic procedure. The PGI differs from previous GDD with regard to the smaller size of the drainage tube., Objective: This study analyses 6‑months results of the PGI in terms of effectiveness and safety., Methods: A database of patients treated with the PGI at the University Eye Hospital Bonn was created and continuously updated based on follow-up controls. Statistical analysis was performed using SPSS Statistics for Windows (IBM Corp., Armonk, NY, USA)., Results: A total of 53 eyes of the first 51 consecutive patients treated with the PGI were included in this study. Mean intraocular pressure was 26.62 mmHg (7-48 mmHg) preoperatively and reduced to 12.20 mmHg (3-22 mmHg) after 6 months. Local pressure-lowering therapy was reduced from 3.37 agents preoperatively to 0.30 agents after 6 months. The complication rate was low; only 3 patients (5.8%) had persistent hypotony. In 16 patients, the intraluminal prolene stent was removed in the postoperative course after an average of 2.9 months. Thereafter, these patients experienced a reduction of intraocular pressure from 22.21 to 11.07 mmHg., Conclusion: The PAUL® Glaucoma Implant is a safe treatment modality that can successfully reduce intraocular pressure to a low level and reduce pressure-lowering local therapy. It has a low complication rate, particularly regarding postoperative hypotony., (© 2022. The Author(s).)

Published
2022
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