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Deze abstract is toegekend aan sessie SBO-BOG Free papers: Chirugische retina en vitreum / Rétine chirugicale et vitré
TitelPharmacological release of focal vitreomacular adhesion using microplasmin: results of a phase 2 clinical trial.
DoelFocal 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.
MethodesThis 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.
ResultatenEach 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.
ConclusieEncouraging results from this trial support continued clinical development of microplasmin for nonsurgical treatment of focal vitreomacular adhesion.
Auteur 1
NaamSTALMANS
InitialenP
InstituutOphthalmology UZLeuven
StadLeuven
Auteur 2
NaamVan Calster
InitialenJ
InstituutOphthalmology UZLeuven
StadLeuven
Auteur 3
NaamDeghislage
InitialenC
InstituutOphthalmology UZLeuven
StadLeuven
Auteur 4
NaamDe Smet
InitialenM
InstituutMiddelheim Hospital
StadAntwerpen
Auteur 5
NaamDelaey
InitialenC
InstituutUGent
StadGent
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