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. Issue 1 (19th March 2021)

• Record Type: Journal Article
• Authors: Stahl, Andreas; Bründer, Marie‐Christine; Lagrèze, Wolf A.; Molnár, Fanni E.; Barth, Teresa; Eter, Nicole; Guthoff, Rainer; Krohne, Tim U.; Pfeil, Johanna M.
• Other Names: Bühler Anima investigator.; Daniel Moritz investigator.; Felzmann Susanne investigator.; Gross Nikolai investigator.; Horn Stefanie investigator.; Müller Claudia investigator.; Reichl Sabine investigator.; Reiff Charlotte investigator.; Richter Olga investigator.; Stech Milena investigator.; Hentschel Roland investigator.; Stavropoulou Dimitra investigator.; Tautz Juliane investigator.; Bartsch Kerstin investigator.; Braunstein Jennifer investigator.; Brinken Ralf investigator.; Brinkmann Christian K investigator.; Czauderna Joanna investigator.; Dralle Wiebke investigator.; Gliem Martin investigator.; Goebel Arno investigator.; Heymer Philipp investigator.; Hofmann Martina investigator.; Holz Frank G investigator.; Kupitz David investigator.; Müller Philipp investigator.; Petrak Michael investigator.; Schmitz Eva J investigator.; Schmitz‐Valckenberg Steffen investigator.; Schröder Moritz investigator.; Steinberg Julia investigator.; Supé Julia investigator.; Kant Evelyn investigator.; Kunze Diana investigator.; Müller Andreas investigator.; Adorf Adeline investigator.; Alex Anne investigator.; Alten Florian investigator.; Clemens Christoph R investigator.; Falkenau Silvia investigator.; Friedhoff Caroline investigator.; Loos Desiree Sandra investigator.; Mihailovic Natasa investigator.; Termühlen Julia investigator.; Uhlig Constantin investigator.; Hörnig‐Franz Isabell investigator.; Rieger‐Fackeldey Esther investigator.; Tekaat Maria investigator.; Werner Claudius investigator.; Altmann Mathias investigator.; Blecha Christiane investigator.; Brandl Sabine investigator.; Helbig Horst investigator.; Hufendiek Karsten investigator.; Jägle Herbert investigator.; Konrad Julia investigator.; Kopetzky Eva investigator.; Lehmann Fabian investigator.; Oberacher‐Velten Isabel investigator.; Keller‐Wackerbauer Annette investigator.; Kittel Jochen investigator.; Segerer Hugo investigator.; Ackermann Phillip investigator.; Benga Jemina investigator.; Guthoff Tanja investigator.; Kleinert Elena investigator.; Mayatepek Ertan investigator.; Schrader Stefan investigator.; Völker Magdalena investigator.; Höhn Thomas investigator.; Lohmeier Klaus investigator.; Sabir Hemmen investigator.; Mayatepek Ertan investigator.; Brevis Francisco investigator.; Mönig Tina investigator.; Schwarz Simone investigator.; Ehmer Angela investigator.; Meltendorf Synke investigator.; Schuart Claudia investigator.; Avenarius Stefan investigator.; Böttger Ralf investigator.; Apel Christoph investigator.; Bergmann Anne investigator.; Herrmann Karsten investigator.; Ockert‐Schön Franziska investigator.; Wegener Sabine investigator.; Ehrt Oliver investigator.; Nentwich Martin investigator.; Pressler Angelika investigator.; Rudolph Günther investigator.; Genzel‐Boroviczeny Orsolya investigator.; Schmidt Susanne investigator.; Münch Hans‐Georg investigator.; Thilmany Claude investigator.; Aisenbrey Sabine investigator.; Bruckmann Anna investigator.; Dimopoulos Spyridon investigator.; Hagemann Ulrike investigator.; Inhoffen Werner investigator.; Partsch Michael investigator.; Schrader Merle investigator.; Süsskind Daniela investigator.; Völker Michael investigator.; Bialkowski Anja investigator.; Müller‐Hansen Ingo investigator.; Gerberth Andrea investigator.; Hasselbach Heike Christine investigator.; Lindemann Solveig investigator.; Purtskhvanidze Konstantine investigator.; Raffel Yvonne investigator.; Roider Johann investigator.; Gerding Heinrich investigator.; Jandeck Claudia investigator.; Smith Lois investigator.;
• Is Part Of: Acta ophthalmologica. Volume 100:Issue 1(2022)
• Page Start: e91
• Page End: e99
• Publication Date: 2021-03-19
• Subjects: anti‐vascular endothelial growth factor -- long‐term outcomes -- ranibizumab -- retinopathy of prematurity; Ophthalmology -- Periodicals; 617.7005
• DOI: 10.1111/aos.14852
• Languages: English
• ISSNs: 1755-375X

Abstract

Abstract: 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.