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This abstract is assigned to session SBO-BOG Free papers: Chirugische retina en vitreum / Rétine chirugicale et vitré

Title

Pharmacological release of focal vitreomacular adhesion using microplasmin: results of a phase 2 clinical trial.

Purpose	Focal vitreomacular adhesion with decrease of visual acuity is a common indication for vitrectomy; however pharmacological release of the traction from the fovea by using intravitreal injections of microplasmin may omit the need to perform surgery. The MIVI–IIT (Traction) evaluates the ability of a single or repeated injection of microplasmin to induce a posterior vitreous detachment.
Methods	This Phase II clinical trial is a randomized double-masked trial with control sham injection. Patients in each cohort were randomized to active treatment or sham injection in a 4:1 ratio, with each cohort including 15 patients. In the first three, successive cohorts increasing doses of microplasmin (75, 125 and 175 µg) were injected intravitreally at baseline. In the fourth cohort, a 125 µg dose was injected at baseline and after four weeks, if no release of traction, a second dose (no sham) was injected, and after an additional four weeks, if still no release of traction, a third dose (no sham) was injected.
Results	Each patient was examined at several time intervals up to six months after the injection using ultrasound B-scan and optical coherence tomography (OCT). Full 6-month follow-up results will be shown for the first three cohorts, as well as the preliminary follow-up of patients in cohort 4. The results presented will evaluate microplasmin’s ability to address these conditions which would otherwise require vitrectomy.
Conclusion	Encouraging results from this trial support continued clinical development of microplasmin for nonsurgical treatment of focal vitreomacular adhesion.

Author 1

Last name	STALMANS
Initials	P
Department	Ophthalmology UZLeuven
City	Leuven

Author 2

Last name	Van Calster
Initials	J
Department	Ophthalmology UZLeuven
City	Leuven

Author 3

Last name	Deghislage
Initials	C
Department	Ophthalmology UZLeuven
City	Leuven

Author 4

Last name	De Smet
Initials	M
Department	Middelheim Hospital
City	Antwerpen

Author 5

Last name	Delaey
Initials	C
Department	UGent
City	Gent