Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial-Reference-Cited by-同舟云学术

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

Published:2024-06-25 Issue:7 Volume:19 Page:823-829
ISSN:1747-4930
Container-title:International Journal of Stroke
language:en
Short-container-title:International Journal of Stroke

Author:

Poli Sven¹²^ORCID,Grohmann Carsten³,Wenzel Daniel A⁴,Poli Khouloud¹²,Tünnerhoff Johannes¹²^ORCID,Nedelmann Max⁵,Fiehler Jens⁶⁷,Burghaus Ina⁸,Lehmann Monika⁸,Glauch Monika⁹,Schadwinkel Hauke M³,Kalmbach Pia¹²,Zeller Julia¹²,Peters Tobias⁴,Eschenfelder Christoph¹⁰,Agostini Hansjürgen¹¹,Campbell Bruce CV¹²^ORCID,Fischer M Dominik¹³¹⁴,Sykora Marek¹⁵¹⁶,Mac Grory Brian¹⁷¹⁸,Feltgen Nicolas¹⁹,Kowarik Markus¹²,Seiffge David²⁰^ORCID,Strbian Daniel²¹,Albrecht Michael²²,Alzureiqi Mohammad S²³,Auffarth Gerd²²,Bäzner Hansjörg²⁴,Behnke Stefanie²⁵,Berberich Anne²⁶,Bode Felix²⁷,Bohmann Ferdinand O²⁸,Cheng Bastian²⁹,Czihal Michael³⁰,Danyel Leon A.³¹,Dimopoulos Spyridon⁴,Pinhal Ferreira de Pinho João D³²,Fries Fabian N³³,Gamulescu Maria-Andreea³⁴,Gekeler Florian³⁵,Gomez-Exposito Alexandra¹²,Gumbinger Christoph³⁶,Guthoff Rainer³⁷,Hattenbach Lars-Olof³⁸,Kellert Lars³⁹,Khoramnia Ramin²²,Kohnen Thomas⁴⁰,Kürten David⁴¹,Lackner Bernhard³⁵,Laible Mona⁴²,Lee John-Ih⁴³,Leithner Christoph³¹,Liegl Raffael⁴⁴,Lochner Piergiorgio⁴⁵,Mackert Marc⁴⁶,Mbroh Joshua¹²,Müller Susanne⁴²,Nagel Simon²⁶,Prasuhn Michelle⁴⁷,Purrucker Jan³⁶,Reich Arno³²,Mundiyanapurath Sibu³⁶,Royl Georg⁴⁸,Salchow Daniel J²³,Schäfer Jan H²⁸,Schlachetzki Felix⁴⁹,Schmack Ingo⁴⁰,Thomalla Götz²⁹,Tieck Fernandez Maria P¹²,Wakili Philip⁵⁰,Walter Peter⁴¹,Wolf Armin⁵⁰,Wolf Marc²⁴,Bartz-Schmidt Karl U⁴,Schultheiss Maximilian³⁵¹,Spitzer Martin S³

Affiliation:

1. Department of Neurology & Stroke, University of Tübingen, Germany

2. Hertie Institute for Clinical Brain Research, University of Tübingen, Germany

3. Department of Ophthalmology, Medical Center Hamburg-Eppendorf, Hamburg, Germany

4. Department of Ophthalmology, University of Tübingen, Germany

5. Department of Neurology, Regio Kliniken GmbH, Pinneberg, Germany

6. Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

7. Eppdata GmbH, Hamburg, Germany

8. Coordination Centre for Clinical Trials (KKS), Medical Faculty & Heidelberg University Hospital, Germany

9. Center for Rare Diseases, University of Tübingen, Germany

10. Boehringer Ingelheim, Ingelheim, Germany

11. Department of Ophthalmology, University of Freiburg, Germany

12. Department of Medicine and Neurology, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia

13. Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, UK

14. Nuffield Laboratory of Ophthalmology, University of Oxford, UK

15. Department of Neurology, St. John’s Hospital, Vienna, Austria

16. Medical Faculty, Sigmund Freud University, Vienna, Austria

17. Duke Clinical Research Institute, Durham, NC, USA

18. Department of Neurology, Duke University School of Medicine, Durham, NC, USA

19. Department of Ophthalmology, Universitätsspital Basel, Switzerland

20. Department of Neurology, University of Bern, Switzerland

21. Department of Neurology, Helsinki University Hospital and University of Helsinki, Finland

22. Department of Ophthalmology, University of Heidelberg, Germany

23. Department of Ophthalmology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany

24. Department of Neurology, Klinikum Stuttgart, Germany

25. Department of Neurology, Klinik Sulzbach, Knappschaftsklinikum Saar, Germany

26. Department of Neurology, Klinikum Ludwigshafen, Germany

27. Department of Neurology, University Hospital Bonn, Germany

28. Department of Neurology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany

29. Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

30. Medical Clinic and Policlinic IV, Division of Vascular Medicine, Ludwig Maximilian University (LMU), Munich, Germany

31. Department of Neurology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany

32. Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany

33. Department of Ophthalmology, Saarland University Medical Center, Homburg/Saar, Germany

34. Department of Ophthalmology, University Hospital Regensburg, Germany

35. Department of Ophthalmology, Klinikum Stuttgart, Germany

36. Department of Neurology, University of Heidelberg, Germany

37. Department of Ophthalmology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany

38. Department of Ophthalmology, Klinikum Ludwigshafen, Germany

39. Department of Neurology, Ludwig Maximilian University (LMU), Munich, Germany

40. Department of Ophthalmology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany

41. Department of Ophthalmology, University Hospital, RWTH Aachen University, Aachen, Germany

42. Department of Neurology, University Hospital Ulm, Germany

43. Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany

44. Department of Ophthalmology, University Hospital Bonn, Germany

45. Department of Neurology, Saarland University Medical Center, Homburg/Saar, Germany

46. Department of Ophthalmology, Ludwig Maximilian University (LMU), Munich, Germany

47. Department of Ophthalmology, University Medical Center Schleswig-Holstein, Campus Lübeck, Germany

48. Department of Neurology, University Medical Center Schleswig-Holstein, Campus Lübeck, Germany

49. Department of Neurology, University Hospital Regensburg, Germany

50. Department of Ophthalmology, Klinik Sulzbach, Knappschaftsklinikum Saar, Germany

51. AugenChirurgie München, Eye Clinic Herzog Carl Theodor, Munich, Germany

Abstract

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.

Funder

Bundesministerium für Bildung und Forschung

Publisher

SAGE Publications

Link

https://journals.sagepub.com/doi/pdf/10.1177/17474930241248516

Reference24 articles.

1. Thrombolysis for Central Retinal Artery Occlusion

2. Retinal and Ophthalmic Artery Occlusions Preferred Practice Pattern®

3. Evidence for an enduring ischaemic penumbra following central retinal artery occlusion, with implications for fibrinolytic therapy

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