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

被引：7

作者：

Poli, Sven ^{[1
,2
]}

Grohmann, Carsten ^{[3
]}

Wenzel, Daniel A. ^{[4
]}

Poli, Khouloud ^{[1
,2
]}

Tuennerhoff, Johannes ^{[1
,2
]}

Nedelmann, Max ^{[5
]}

Fiehler, Jens ^{[6
,7
]}

Burghaus, Ina ^{[8
,9
]}

Lehmann, Monika ^{[8
,9
]}

Glauch, Monika ^{[10
]}

Schadwinkel, Hauke M. ^{[3
]}

Kalmbach, Pia ^{[1
,2
]}

Zeller, Julia ^{[1
,2
]}

Peters, Tobias ^{[4
]}

Eschenfelder, Christoph ^{[11
]}

Agostini, Hansjuergen ^{[12
]}

Campbell, Bruce C., V ^{[13
]}

Fischer, M. Dominik ^{[14
,15
]}

Sykora, Marek ^{[16
,17
]}

Mac Grory, Brian ^{[18
,19
]}

Feltgen, Nicolas ^{[20
]}

Kowarik, Markus ^{[1
,2
]}

Seiffge, David ^{[21
]}

Strbian, Daniel ^{[22
,23
]}

Albrecht, Michael ^{[24
]}

Alzureiqi, Mohammad S. ^{[25
,26
,27
]}

Auffarth, Gerd ^{[24
]}

Baezner, Hansjoerg ^{[28
]}

Behnke, Stefanie ^{[29
]}

Berberich, Anne ^{[30
]}

Bode, Felix ^{[31
]}

Bohmann, Ferdinand O. ^{[32
]}

Cheng, Bastian ^{[33
]}

Czihal, Michael ^{[34
]}

Danyel, Leon A. ^{[26
,27
,35
]}

Dimopoulos, Spyridon ^{[4
]}

de Pinho, Joao D. Pinhal Ferreira ^{[36
]}

Fries, Fabian N. ^{[37
]}

Gamulescu, Maria-Andreea ^{[38
]}

Gekeler, Florian ^{[39
]}

Gomez-Exposito, Alexandra ^{[1
,2
]}

Gumbinger, Christoph ^{[40
]}

Guthoff, Rainer ^{[41
,42
]}

Hattenbach, Lars-Olof ^{[43
]}

Kellert, Lars ^{[44
]}

Khoramnia, Ramin ^{[24
]}

Kohnen, Thomas ^{[45
]}

Kuerten, David ^{[46
]}

Lackner, Bernhard ^{[39
]}

Laible, Mona ^{[47
]}

机构：

[1] Univ Tubingen, Dept Neurol & Stroke, Tubingen, Germany

[2] Univ Tubingen, Hertie Inst Clin Brain Res, Tubingen, Germany

[3] Med Ctr Hamburg Eppendorf, Dept Ophthalmol, Hamburg, Germany

[4] Univ Tubingen, Dept Ophthalmol, Tubingen, Germany

[5] Regio Kliniken GmbH, Dept Neurol, Pinneberg, Germany

[6] Univ Med Ctr Hamburg Eppendorf, Neuroradiol, Hamburg, Germany

[7] Eppdata GmbH, Hamburg, Germany

[8] Coordinat Ctr Clin Trials KKS, Med Fac, Heidelberg, Germany

[9] Heidelberg Univ Hosp, Heidelberg, Germany

[10] Univ Tubingen, Ctr Rare Dis, Tubingen, Germany

[11] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany

[12] Univ Freiburg, Dept Ophthalmol, Freiburg, Germany

[13] Univ Melbourne, Royal Melbourne Hosp, Dept Med & Neurol, Parkville, Vic, Australia

[14] Oxford Univ Hosp NHS Fdn Trust, Oxford Eye Hosp, Oxford, England

[15] Univ Oxford, Nuffield Lab Ophthalmol, Oxford, England

[16] St Johns Hosp, Dept Neurol, Vienna, Austria

[17] Sigmund Freud Univ, Med Fac, Vienna, Austria

[18] Duke Clin Res Inst, Durham, NC USA

[19] Duke Univ, Sch Med, Dept Neurol, Durham, NC USA

[20] Univ Spital Basel, Dept Ophthalmol, Basel, Switzerland

[21] Univ Bern, Dept Neurol, Bern, Switzerland

[22] Helsinki Univ Hosp, Dept Neurol, Helsinki, Finland

[23] Univ Helsinki, Helsinki, Finland

[24] Heidelberg Univ, Dept Ophthalmol, Heidelberg, Germany

[25] Charite Univ med Berlin, Dept Ophthalmol, Berlin, Germany

[26] Free Univ Berlin, Berlin, Germany

[27] Humboldt Univ, Berlin, Germany

[28] Klinikum Stuttgart, Dept Neurol, Stuttgart, Germany

[29] Knappschaftsklinikum Saar, Dept Neurol, Klin Sulzbach, Sulzbach, Germany

[30] Klinikum Ludwigshafen, Dept Neurol, Ludwigshafen, Germany

[31] Univ Hosp Bonn, Dept Neurol, Bonn, Germany

[32] Goethe Univ, Univ Hosp Frankfurt, Dept Neurol, Frankfurt, Germany

[33] Univ Med Ctr Hamburg Eppendorf, Dept Neurol, Hamburg, Germany

[34] Ludwig Maximilian Univ LMU, Div Vasc Med, Med Clin & Policlin 4, Munich, Germany

[35] Charite Univ med Berlin, Dept Neurol, Berlin, Germany

[36] Rhein Westfal TH Aachen, Univ Hosp, Dept Neurol, Aachen, Germany

[37] Saarland Univ, Med Ctr, Dept Ophthalmol, Homburg Saar, Germany

[38] Univ Hosp Regensburg, Dept Ophthalmol, Regensburg, Germany

[39] Klinikum Stuttgart, Dept Ophthalmol, Stuttgart, Germany

[40] Heidelberg Univ, Dept Neurol, Heidelberg, Germany

[41] Heinrich Heine Univ Dusseldorf, Med Fac, Dept Ophthalmol, Dusseldorf, Germany

[42] Heinrich Heine Univ Dusseldorf, Univ Hosp Dusseldorf, Dusseldorf, Germany

[43] Klinikum Ludwigshafen, Dept Ophthalmol, Ludwigshafen, Germany

[44] Ludwig Maximilian Univ LMU, Dept Neurol, Munich, Germany

[45] Goethe Univ, Univ Hosp Frankfurt, Dept Ophthalmol, Frankfurt, Germany

[46] Rhein Westfal TH Aachen, Univ Hosp, Dept Ophthalmol, Aachen, Germany

[47] Univ Hosp Ulm, Dept Neurol, Ulm, Germany

[48] Heinrich Heine Univ Dusseldorf, Med Fac, Dept Neurol, Dusseldorf, Germany

[49] Univ Hosp Bonn, Dept Ophthalmol, Bonn, Germany

[50] Saarland Univ, Med Ctr, Dept Neurol, Homburg Saar, Germany

来源：

INTERNATIONAL JOURNAL OF STROKE | 2024年 / 19卷 / 07期

关键词：

Central retinal artery occlusion; CRAO; reperfusion; intravenous thrombolysis; ISCHEMIC-STROKE; FIBRINOLYSIS;

D O I：

10.1177/17474930241248516

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：823 / 829

页数：7

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