Intravitreal injection of microplasmin for treatment of vitreomacular adhesion: results of a prospective, randomized, sham-controlled phase II trial (the MIVI-IIT trial).
OBJECTIVE
Vitreomacular adhesion causing vitreomacular traction is a common indication for vitrectomy. It may be avoided by using enzymatic vitreolysis. The MIVI-IIT (traction) study evaluated the ability of a single or repeated injection of microplasmin to release vitreomacular traction.


METHODS
This randomized, double-masked, Phase II trial with control sham injection enrolled 60 patients. Patients in each of the 4 cohorts were randomized (4:1) to active treatment or sham injection. In the first 3 cohorts, increasing doses of microplasmin (75, 125, and 175 microg) were administered. In the fourth cohort, an initial injection of 125 microg microplasmin or sham was administered followed 1 month later by an injection of 125 microg microplasmin if no release of adhesion occurred. A third dose was injected 4 weeks later if there was still no release of adhesion.


RESULTS
Within 28 days of sham, 75, 125, and 175 microg microplasmin administration, nonsurgical resolution of vitreomacular adhesion was observed in 8, 25, 44, and 27% of the patients, respectively. When the 125 microg dose was repeated up to 3 times, adhesion release was observed in 58% of patients 28 days after the final injection.


CONCLUSIONS
These results provide support for the potential of microplasmin as a nonsurgical treatment for vitreomacular adhesion.
Stalmans
Peter
P
Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium. Peter.Stalmans@uzleuven.be
Delaey
Christophe
C
de Smet
Marc D
MD
van Dijkman
Edith
E
Pakola
Steve
S
D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005341:Fibrinolysin / Q000008:administration & dosage*; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage*; D011446:Prospective Studies; D012167:Retinal Perforations / Q000188:drug therapy*; D000267:Tissue Adhesions / Q000188:drug therapy; D014792:Visual Acuity; D014822:Vitreous Body; D020255:Vitreous Detachment / Q000188:drug therapy*
D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin