Early REperfusion Therapy with Intravenous Alteplase for Recovery of VISION in Acute Central Retinal Artery Occlusion (REVISION): Study Protocol of a Phase III Trial.

Poli, Sven; Grohmann, Carsten; Wenzel, Daniel A; Poli, Khouloud; Tuennerhoff, Johannes; Nedelmann, Max; Fiehler, Jens; Agostini, Hansjürgen; Campbell, Bruce; Fischer, Dominik M; Sykora, Marek; Mac Grory, Brian; Feltgen, Nicolas; Seiffge, David J; Strbian, Daniel; Schultheiß, Maximilian; 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. (In Press). International journal of stroke, p. 17474930241248516. SAGE 10.1177/17474930241248516

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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 is lacking to address this question.

AIMS

REVISION investigates intravenous alteplase within 4.5 hours of monocular vision loss due to acute CRAO.

METHODS

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 An-gle of Resolution of 0.5 or less at 30 days (intention-to-treat analysis). Secondary efficacy out-comes 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 tomogra-phy/angiography, ultrasound and 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 hours 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 trans-late to CRAO with its similar pathophysiology.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT04965038; EU Trial Number: 2023-507388-21-00.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
UniBE Contributor:	Seiffge, David Julian
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1747-4949
Publisher:	SAGE
Language:	English
Submitter:	Pubmed Import
Date Deposited:	10 Apr 2024 08:25
Last Modified:	10 Apr 2024 08:25
Publisher DOI:	10.1177/17474930241248516
PubMed ID:	38591748
Uncontrolled Keywords:	CRAO Reperfusion alteplase central retinal artery occlusion intravenous thrombolysis tPA tissue plasminogen activator
URI:	https://boris.unibe.ch/id/eprint/195827