Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial.

Autor:	Poli S; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Grohmann C; Department of Ophthalmology, Medical Center Hamburg-Eppendorf, Hamburg, Germany., Wenzel DA; Department of Ophthalmology, University of Tübingen, Germany., Poli K; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Tünnerhoff J; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Nedelmann M; Department of Neurology, Regio Kliniken GmbH, Pinneberg, Germany., Fiehler J; Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.; Eppdata GmbH, Hamburg, Germany., Burghaus I; Coordination Centre for Clinical Trials (KKS), Medical Faculty & Heidelberg University Hospital, Germany., Lehmann M; Coordination Centre for Clinical Trials (KKS), Medical Faculty & Heidelberg University Hospital, Germany., Glauch M; Center for Rare Diseases, University of Tübingen, Germany., Schadwinkel HM; Department of Ophthalmology, Medical Center Hamburg-Eppendorf, Hamburg, Germany., Kalmbach P; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Zeller J; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Peters T; Department of Ophthalmology, University of Tübingen, Germany., Eschenfelder C; Boehringer Ingelheim, Ingelheim, Germany., Agostini H; Department of Ophthalmology, University of Freiburg, Germany., Campbell BC; Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia., Fischer MD; Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, UK.; Nuffield Laboratory of Ophthalmology, University of Oxford, UK., Sykora M; Department of Neurology, St. John's Hospital, Vienna, Austria.; Medical Faculty, Sigmund Freud University, Vienna, Austria., Mac Grory B; Duke Clinical Research Institute, Durham, NC, USA.; Department of Neurology, Duke University School of Medicine, Durham, NC, USA., Feltgen N; Department of Ophthalmology, Universitätsspital Basel, Switzerland., Kowarik M; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Seiffge D; Department of Neurology, University of Bern, Switzerland., Strbian D; Department of Neurology, Helsinki University Hospital and University of Helsinki, Finland., Albrecht M; Department of Ophthalmology, University of Heidelberg, Germany., Alzureiqi MS; Department of Ophthalmology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany., Auffarth G; Department of Ophthalmology, University of Heidelberg, Germany., Bäzner H; Department of Neurology, Klinikum Stuttgart, Germany., Behnke S; Department of Neurology, Klinik Sulzbach, Knappschaftsklinikum Saar, Germany., Berberich A; Department of Neurology, Klinikum Ludwigshafen, Germany., Bode F; Department of Neurology, University Hospital Bonn, Germany., Bohmann FO; Department of Neurology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany., Cheng B; Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Czihal M; Medical Clinic and Policlinic IV, Division of Vascular Medicine, Ludwig Maximilian University (LMU), Munich, Germany., Danyel LA; Department of Neurology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany., Dimopoulos S; Department of Ophthalmology, University of Tübingen, Germany., Pinhal Ferreira de Pinho JD; Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany., Fries FN; Department of Ophthalmology, Saarland University Medical Center, Homburg/Saar, Germany., Gamulescu MA; Department of Ophthalmology, University Hospital Regensburg, Germany., Gekeler F; Department of Ophthalmology, Klinikum Stuttgart, Germany., Gomez-Exposito A; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Gumbinger C; Department of Neurology, University of Heidelberg, Germany., Guthoff R; Department of Ophthalmology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany., Hattenbach LO; Department of Ophthalmology, Klinikum Ludwigshafen, Germany., Kellert L; Department of Neurology, Ludwig Maximilian University (LMU), Munich, Germany., Khoramnia R; Department of Ophthalmology, University of Heidelberg, Germany., Kohnen T; Department of Ophthalmology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany., Kürten D; Department of Ophthalmology, University Hospital, RWTH Aachen University, Aachen, Germany., Lackner B; Department of Ophthalmology, Klinikum Stuttgart, Germany., Laible M; Department of Neurology, University Hospital Ulm, Germany., Lee JI; Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany., Leithner C; Department of Neurology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany., Liegl R; Department of Ophthalmology, University Hospital Bonn, Germany., Lochner P; Department of Neurology, Saarland University Medical Center, Homburg/Saar, Germany., Mackert M; Department of Ophthalmology, Ludwig Maximilian University (LMU), Munich, Germany., Mbroh J; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Müller S; Department of Neurology, University Hospital Ulm, Germany., Nagel S; Department of Neurology, Klinikum Ludwigshafen, Germany., Prasuhn M; Department of Ophthalmology, University Medical Center Schleswig-Holstein, Campus Lübeck, Germany., Purrucker J; Department of Neurology, University of Heidelberg, Germany., Reich A; Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany., Mundiyanapurath S; Department of Neurology, University of Heidelberg, Germany., Royl G; Department of Neurology, University Medical Center Schleswig-Holstein, Campus Lübeck, Germany., Salchow DJ; Department of Ophthalmology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany., Schäfer JH; Department of Neurology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany., Schlachetzki F; Department of Neurology, University Hospital Regensburg, Germany., Schmack I; Department of Ophthalmology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany., Thomalla G; Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Tieck Fernandez MP; Department of Neurology & Stroke, University of Tübingen, Germany.; Hertie Institute for Clinical Brain Research, University of Tübingen, Germany., Wakili P; Department of Ophthalmology, Klinik Sulzbach, Knappschaftsklinikum Saar, Germany., Walter P; Department of Ophthalmology, University Hospital, RWTH Aachen University, Aachen, Germany., Wolf A; Department of Ophthalmology, Klinik Sulzbach, Knappschaftsklinikum Saar, Germany., Wolf M; Department of Neurology, Klinikum Stuttgart, Germany., Bartz-Schmidt KU; Department of Ophthalmology, University of Tübingen, Germany., Schultheiss M; Department of Ophthalmology, Medical Center Hamburg-Eppendorf, Hamburg, Germany.; AugenChirurgie München, Eye Clinic Herzog Carl Theodor, Munich, Germany., Spitzer MS; Department of Ophthalmology, Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Jazyk:	angličtina
Zdroj:	International journal of stroke : official journal of the International Stroke Society [Int J Stroke] 2024 Aug; Vol. 19 (7), pp. 823-829. Date of Electronic Publication: 2024 Jun 25.
DOI:	10.1177/17474930241248516
Abstrakt:	Rationale: Meta-analyses of case series of non-arteritic central retinal artery occlusion (CRAO) indicate beneficial effects of intravenous thrombolysis when initiated early after symptom onset. Randomized data are lacking to address this question. Aims: The REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION) investigates intravenous alteplase within 4.5 h of monocular vision loss due to acute CRAO. Methods: This study is the randomized (1:1), double-blind, placebo-controlled, multicenter adaptive phase III trial. Study Outcomes: Primary outcome is functional recovery to normal or mildly impaired vision in the affected eye defined as best-corrected visual acuity of the Logarithm of the Minimum Angle of Resolution of 0.5 or less at 30 days (intention-to-treat analysis). Secondary efficacy outcomes include modified Rankin Score at 90 days and quality of life. Safety outcomes include symptomatic intracranial hemorrhage, major bleeding (International Society on Thrombosis and Haemostasis definition) and mortality. Exploratory analyses of optical coherence tomography/angiography, ultrasound and magnetic resonance imaging (MRI) biomarkers will be conducted. Sample Size: Using an adaptive design with interim analysis at 120 patients, up to 422 participants (211 per arm) would be needed for 80% power (one-sided alpha = 0.025) to detect a difference of 15%, assuming functional recovery rates of 10% in the placebo arm and 25% in the alteplase arm. Discussion: By enrolling patients within 4.5 h of CRAO onset, REVISION uses insights from meta-analyses of CRAO case series and randomized thrombolysis trials in acute ischemic stroke. Increased rates of early reperfusion and good neurological outcomes in stroke may translate to CRAO with its similar pathophysiology. Trial Registration: ClinicalTrials.gov: NCT04965038; EU Trial Number: 2023-507388-21-00. Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Alteplase/placebo is provided by Boehringer Ingelheim at no costs. Boehringer Ingelheim was given opportunity to review the manuscript for medical/scientific accuracy and intellectual property considerations. The authors did not receive any payment related to trial/manuscript development.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu