Central Retinal Artery Occlusion: Local Intra-arterial Fibrinolysis versus Conservative Treatment, a Multicenter Randomized Trial
Presented at: Euretina meeting, May 2008, Vienna, Austria; meeting of the German Retinological Society, June 2008, Wuerzburg, Germany; meeting of the German Society of Ophthalmology, September 2008, Berlin, Germany; and annual meeting of the European Society of Neuroradiology, October 2009, Athens.
Received 14 September 2009; received in revised form 22 March 2010; accepted 29 March 2010.
Purpose
The reported outcomes of central retinal artery occlusion (CRAO) with or without treatment vary considerably. Although local intra-arterial fibrinolysis (LIF) using recombinant tissue plasminogen activator (rtPA) is a promising treatment, outcomes have not been compared in randomized trials.
Design
Prospective randomized multicenter clinical trial (the European Assessment Group for Lysis in the Eye Study) to compare treatment outcome after conservative standard treatment (CST) and LIF for acute nonarteritic CRAO.
Participants
Between 2002 and 2007, 9 centers in Austria and Germany recruited 84 patients (40 received CST, 44 received LIF), and data for 82 patients were analyzed.
Methods
Patients (age 18–75 years) with CRAO, symptoms for 20 hours or less, and best-corrected visual acuity (BCVA) <0.5 logarithm of the minimum angle of resolution (logMAR) were randomized to the CST or LIF group.
Main Outcome Measures
The primary end point was BCVA after 1 month; the secondary end point was safety.
Results
The mean interval between first symptoms and therapy was 10.99±5.49 hours (CST) and 12.78±5.77 hours (LIF). The mean BCVA (logMAR) improved significantly in both groups (CST: −0.44 [standard deviation 0.55]; LIF: −0.45 [standard deviation 0.55]; both P < 0.0001) and did not differ between groups (P=0.69). Clinically significant visual improvement (≥0.3 logMAR) was noted in 60.0% (CST) and 57.1% (LIF) of patients. Two patients in the CST group (4.3%) and 13 patients in the LIF group (37.1%) had adverse reactions. Because of apparently similar efficacy and the higher rate of adverse reactions in the LIF group, the study was stopped after the first interim analysis at the recommendation of the data and safety monitoring committee.
Conclusions
In light of these 2 therapies' similar outcomes and the higher rate of adverse reactions associated with LIF, we cannot recommend LIF for the management of acute CRAO.
Financial Disclosure(s)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
1Clinic of Neuroradiology, University of Freiburg, Germany
2Department of Ophthalmology, University of Freiburg, Germany
3Clinical Trials Center, University of Freiburg, Germany
4Department of Neuroradiology, University of Essen, Germany
5Department of Ophthalmology, University of Essen, Germany
6Department of Neuroradiology, University of Wuerzburg, Germany
7Department of Neuroradiology, University of Muenchen, Germany
8Department of Ophthalmology, University of Muenchen, Germany
9Department of Ophthalmology, University of Goettingen, Germany
Correspondence: Martin Schumacher, MD, Clinic of Neuroradiology, University of Freiburg, Breisacher Str. 64, 79106 Freiburg, Germany
Manuscript no. 2009-1270.
*European Assessment Group for Lysis in the Eye: A list of members of the EAGLE Collaborative Study Group (Appendix 1) is available at http://aaojournal.org.
Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
The German Research Foundation of Health (DFG), Bonn, Germany, provided financial support (SCHU1454/1-3). The study does not necessarily reflect the view of the Foundation. Boehringer Ingelheim Pharma KG also provided funding. The Clinical Trials Center, University Hospital Freiburg, received funding from the BMBF (Federal Ministry of Education and Research).
ABSTRACT