Central retinal artery occlusion: local intra-arterial fibrinolysis versus conservative treatment, a multicenter randomized trial.
OBJECTIVE
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.


METHODS
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.


METHODS
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.


METHODS
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 (> or = 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.


BACKGROUND
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Schumacher
Martin
M
Clinic of Neuroradiology, University of Freiburg, Germany. martin.schumacher.nrad@uniklinik-freiburg.de
Schmidt
Dieter
D
Jurklies
Bernhard
B
Gall
Christine
C
Wanke
Isabel
I
Schmoor
Claudia
C
Maier-Lenz
Herbert
H
Solymosi
Laszlo
L
Brueckmann
Hartmut
H
Neubauer
Aljoscha S
AS
Wolf
Armin
A
Feltgen
Nicolas
N
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D005342:Fibrinolysis; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007261:Infusions, Intra-Arterial; D008297:Male; D008875:Middle Aged; D009880:Ophthalmic Artery; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D015356:Retinal Artery Occlusion / Q000188:drug therapy* / Q000503:physiopathology; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D005343:Fibrinolytic Agents; D011994:Recombinant Proteins; D010959:Tissue Plasminogen Activator