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Titel	Induction of vitreous detachment using microplasmin in diabetic macular edema: results of a phase II study (MIVI-II-DME)
Abstract Nr.	242

Doel	Taut hyaloid in diabetic patients is commonly treated with vitrectomy. However, pharmacological induction of posterior vitreous detachment using intravitreal injections of microplasmin may omit the need to perform surgery. The MIVI–II-DME study evaluates the ability of a single injection of microplasmin to induce a posterior vitreous detachment in diabetic macular edema.
Methodes	This Phase II clinical trial is a randomized double-masked trial with control sham injection. Diabetic patients with decreased visual acuity and macular edema with attached posterior vitreous were randomized to active treatment or sham injection in a 3:1 ratio, with each cohort including 15 patients (the first cohort was ended after inclusion of the 11th patient). In each successive cohort, increasing doses of microplasmin (25, 75 and 125 µg) were injected intravitreally at baseline.
Resultaten	Each patient was examined at several time intervals up to one year after the injection using ultrasound B-scan and optical coherence tomography (OCT) to determine the adherence of the posterior vitreous on the macula and the occurrence of posterior vitreous detachment. At baseline and at the 6 month and one year visit, fundus photography, fluorescein angiography and ERG were performed to monitor any possible retinal toxicity. Full 6-month follow-up results will be shown for all study patients. The results presented will evaluate the ability of microplasmin to induce posterior vitreous detachment in diabetic patients which would otherwise require vitrectomy.
Conclusie	Encouraging results from this trial support continued clinical development (phase III evaluation) of microplasmin for nonsurgical treatment of vitreomacular traction.

Auteur 1

Naam	STALMANS
Initialen	P
Instituut	Ophthalmology UZLeuven
Stad	Leuven

Auteur 2

Naam	The MIVI-II (DME) Study Group
Stad	Europe