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Ranibizumab in retinopathy of prematurity – one‐year follow‐up of ophthalmic outcomes and two‐year follow‐up of neurodevelopmental outcomes from the CARE‐ROP study

Stahl, Andreas ; Bründer, Marie‐Christine ; Barth, Teresa ; Guthoff, Rainer ; Krohne, Tim U. ; Pfeil, Johanna M. ; Bühler, Anima ; Daniel, Moritz ; Felzmann, Susanne ; Müller, Claudia ; Reichl, Sabine ; Reiff, Charlotte ; Richter, Olga ; Stech, Milena ; Hentschel, Roland ; Stavropoulou, Dimitra ; Tautz, Juliane ; Bartsch, Kerstin ; Braunstein, Jennifer ; Brinken, Ralf ; Brinkmann, Christian K ; Czauderna, Joanna ; Dralle, Wiebke ; Gliem, Martin ; Goebel, Arno ; Heymer, Philipp ; Hofmann, Martina ; Müller, Philipp ; Petrak, Michael ; Schmitz, Eva J ; Schmitz‐Valckenberg, Steffen ; Schröder, Moritz ; Steinberg, Julia ; Supé, Julia ; Kant, Evelyn ; Kunze, Diana ; Müller, Andreas ; Adorf, Adeline ; Alten, Florian ; Clemens, Christoph R ; Friedhoff, Caroline ; Loos, Desiree Sandra ; Mihailovic, Natasa ; Termühlen, Julia ; Uhlig, Constantin ; Hörnig‐Franz, Isabell ; Rieger‐Fackeldey, Esther ; Tekaat, Maria ; Altmann, Mathias ; Blecha, Christiane ; Brandl, Sabine ; Hufendiek, Karsten ; Jägle, Herbert ; Konrad, Julia ; Lehmann, Fabian ; Keller‐Wackerbauer, Annette ; Kittel, Jochen ; Segerer, Hugo ; Ackermann, Phillip ; Benga, Jemina ; Guthoff, Tanja ; Kleinert, Elena ; Mayatepek, Ertan ; Völker, Magdalena ; Höhn, Thomas ; Lohmeier, Klaus ; Sabir, Hemmen ; Mayatepek, Ertan ; Mönig, Tina ; Ehmer, Angela ; Meltendorf, Synke ; Schuart, Claudia ; Avenarius, Stefan ; 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 ; Aisenbrey, Sabine ; Dimopoulos, Spyridon ; Hagemann, Ulrike ; Inhoffen, Werner ; Partsch, Michael ; Schrader, Merle ; Süsskind, Daniela ; Völker, Michael ; Müller‐Hansen, Ingo ; Lindemann, Solveig ; Raffel, Yvonne ; Roider, Johann ; Gerding, Heinrich ; Jandeck, Claudia ; Smith, Lois

Acta ophthalmologica (Oxford, England), 2022-02, Vol.100 (1), p.e91-e99 [Periódico revisado por pares]

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Título:
Ranibizumab in retinopathy of prematurity – one‐year follow‐up of ophthalmic outcomes and two‐year follow‐up of neurodevelopmental outcomes from the CARE‐ROP study
Autor: Stahl, Andreas ; Bründer, Marie‐Christine ; Barth, Teresa ; Guthoff, Rainer ; Krohne, Tim U. ; Pfeil, Johanna M. ; Bühler, Anima ; Daniel, Moritz ; Felzmann, Susanne ; Müller, Claudia ; Reichl, Sabine ; Reiff, Charlotte ; Richter, Olga ; Stech, Milena ; Hentschel, Roland ; Stavropoulou, Dimitra ; Tautz, Juliane ; Bartsch, Kerstin ; Braunstein, Jennifer ; Brinken, Ralf ; Brinkmann, Christian K ; Czauderna, Joanna ; Dralle, Wiebke ; Gliem, Martin ; Goebel, Arno ; Heymer, Philipp ; Hofmann, Martina ; Müller, Philipp ; Petrak, Michael ; Schmitz, Eva J ; Schmitz‐Valckenberg, Steffen ; Schröder, Moritz ; Steinberg, Julia ; Supé, Julia ; Kant, Evelyn ; Kunze, Diana ; Müller, Andreas ; Adorf, Adeline ; Alten, Florian ; Clemens, Christoph R ; Friedhoff, Caroline ; Loos, Desiree Sandra ; Mihailovic, Natasa ; Termühlen, Julia ; Uhlig, Constantin ; Hörnig‐Franz, Isabell ; Rieger‐Fackeldey, Esther ; Tekaat, Maria ; Altmann, Mathias ; Blecha, Christiane ; Brandl, Sabine ; Hufendiek, Karsten ; Jägle, Herbert ; Konrad, Julia ; Lehmann, Fabian ; Keller‐Wackerbauer, Annette ; Kittel, Jochen ; Segerer, Hugo ; Ackermann, Phillip ; Benga, Jemina ; Guthoff, Tanja ; Kleinert, Elena ; Mayatepek, Ertan ; Völker, Magdalena ; Höhn, Thomas ; Lohmeier, Klaus ; Sabir, Hemmen ; Mayatepek, Ertan ; Mönig, Tina ; Ehmer, Angela ; Meltendorf, Synke ; Schuart, Claudia ; Avenarius, Stefan ; 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 ; Aisenbrey, Sabine ; Dimopoulos, Spyridon ; Hagemann, Ulrike ; Inhoffen, Werner ; Partsch, Michael ; Schrader, Merle ; Süsskind, Daniela ; Völker, Michael ; Müller‐Hansen, Ingo ; Lindemann, Solveig ; Raffel, Yvonne ; Roider, Johann ; Gerding, Heinrich ; Jandeck, Claudia ; Smith, Lois
Assuntos: Angiogenesis Inhibitors - administration & dosage ; anti‐vascular endothelial growth factor ; Bevacizumab - administration & dosage ; Double-Blind Method ; Female ; Follow-Up Studies ; Gestational Age ; Humans ; Infant ; Infant, Newborn ; Infants ; Intravitreal Injections ; Laser Coagulation - methods ; long‐term outcomes ; Male ; Mental development ; Monoclonal antibodies ; Neurodevelopmental Disorders - diagnosis ; Nystagmus ; Patients ; Prospective Studies ; ranibizumab ; Ranibizumab - administration & dosage ; Retinopathy ; retinopathy of prematurity ; Retinopathy of Prematurity - physiopathology ; Retinopathy of Prematurity - therapy ; Safety ; Statistical analysis ; Strabismus ; Time Factors ; Treatment Outcome ; Vascular Endothelial Growth Factor A
É parte de: Acta ophthalmologica (Oxford, England), 2022-02, Vol.100 (1), p.e91-e99
Notas: CARE‐ROP study group members are listed in Appendix 1
Funding/support: The University Hospital Freiburg is the study sponsor. Novartis Pharma GmbH, Germany, provided financial support and study medication. Novartis Pharma GmbH was not involved in the design and conduct of the study or collection, management, analysis, and interpretation of the data; Novartis Pharma GmbH was able to review the manuscript prior to submission but was not involved in preparation or approval of the manuscript or the decision to submit the manuscript for publication.
Financial disclosures: AS: speaker fees/honoraria from Allergan, Bayer, Novartis; research funding from Novartis. MCB: speaker fees from Alcon, WAL: speaker fees/honoraria Santhera, Infectopharm, Boehringer Ingelheim. FEM: none. TB: advisory board and research funding from Novartis. NE: research funding/speaker fees from Novartis, Bayer, Allergan, Roche; consultant fees from Bayer; advisor for Apellis Pharmaceuticals, Alcon, Bayer, Novartis, Roche; lecture fees from Apellis Pharmaceuticals, Bayer, Novartis, Roche. RG: none. TUK: consultancy fees/ speaker fees/ travel reimbursement from Alimera Sciences, Allergan, Heidelberg Engineering, Roche; grants and personal fees from Bayer, Novartis. JMP: none
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Descrição: Purpose The primary endpoint results from the comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity (CARE‐ROP) core study identified ranibizumab as an effective treatment to control acute retinopathy of prematurity (ROP). This study reports the 1‐ and 2‐year follow‐up data focusing on long‐term functional outcomes and safety. Methods The CARE‐ROP trial compared 0.12 mg versus 0.20 mg ranibizumab in 20 infants with ROP in a multicentric, prospective, randomized, double‐blind, controlled study design. Sixteen patients entered the follow‐up period. An ophthalmologic assessment at one year postbaseline was acquired from all 16 patients and a neurodevelopmental assessment at two years postbaseline was acquired from 15 patients. Results Fifteen of 16 infants were able to fixate and follow moving objects at one year postbaseline treatment. One child progressed to stage 5 ROP bilaterally between the end of the core study and the 1‐year follow‐up (first seen at PMA 75 weeks). Mean spherical equivalents were −1.9 diopters (D) and −0.75 D in the 0.12 mg and the 0.20 mg treatment arms. Strabismus was present in seven and nystagmus in five out of 16 infants. Mental development scores were within normal limits in six out of ten patients with available data. No statistically significant difference was observed between the two treatment arms. Conclusion Neurodevelopmental and functional ocular outcomes 1 and 2 years after treatment with ranibizumab are reassuring regarding long‐term safety. Late reactivation of ROP, however, represents a challenge during the follow‐up phase and it is of utmost importance that regular follow‐ups are maintained.
Editor: England: Wiley Subscription Services, Inc
Idioma: Inglês

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Ranibizumab in retinopathy of prematurity – one‐year follow‐up of ophthalmic outcomes and two‐year follow‐up of neurodevelopmental outcomes from the CARE‐ROP study

England: Wiley Subscription Services, Inc

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