Poli, Sven and Grohmann, Carsten and Wenzel, Daniel A. and Poli, Khouloud and Tuennerhoff, Johannes and Nedelmann, Max and Fiehler, Jens and Burghaus, Ina and Lehmann, Monika and Glauch, Monika and Schadwinkel, Hauke M. and Kalmbach, Pia and Zeller, Julia and Peters, Tobias and Eschenfelder, Christoph and Agostini, Hansjuergen and Campbell, Bruce C. and Fischer, M. Dominik and Sykora, Marek and Mac Grory, Brian and Feltgen, Nicolas and Kowarik, Markus and Seiffge, David and Strbian, Daniel and Albrecht, Michael and Alzureiqi, Mohammad S. and Auffarth, Gerd and Baezner, Hansjoerg and Behnke, Stefanie and Berberich, Anne and Bode, Felix and Bohmann, Ferdinand O. and Cheng, Bastian and Czihal, Michael and Danyel, Leon A. and Dimopoulos, Spyridon and de Pinho, Joao D. Pinhal Ferreira and Fries, Fabian N. and Gamulescu, Maria-Andreea and Gekeler, Florian and Gomez-Exposito, Alexandra and Gumbinger, Christoph and Guthoff, Rainer and Hattenbach, Lars-Olof and Kellert, Lars and Khoramnia, Ramin and Kohnen, Thomas and Kuerten, David and Lackner, Bernhard and Laible, Mona and Lee, John-Ih and Leithner, Christoph and Liegl, Raffael and Lochner, Piergiorgio and Mackert, Marc and Mbroh, Joshua and Mueller, Susanne and Nagel, Simon and Prasuhn, Michelle and Purrucker, Jan and Reich, Arno and Mundiyanapurath, Sibu and Royl, Georg and Salchow, Daniel J. and Schaefer, Jan H. and Schlachetzki, Felix and Schmack, Ingo and Thomalla, Goetz and Fernandez, Maria P. Tieck and Wakili, Philip and Walter, Peter and Wolf, Armin and Wolf, Marc and Bartz-Schmidt, Karl U. and Schultheiss, Maximilian and Spitzer, Martin S. (2024) Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial. INTERNATIONAL JOURNAL OF STROKE, 19 (7). pp. 823-829. ISSN 1747-4930, 1747-4949
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ISCHEMIC-STROKE; FIBRINOLYSIS; Central retinal artery occlusion; CRAO; reperfusion; intravenous thrombolysis |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Abteilung für Pädiatrische Ophthalmologie, Strabismologie und Ophthalmogenetik Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 20 Aug 2025 08:09 |
| Last Modified: | 20 Aug 2025 08:09 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65567 |
Actions (login required)
 |
View Item |
