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TitreResults of the MIVI-trust phase III clinical trial using microplasmin in the treatment of vitreomacular traction and macular hole.
ButVitreomacular adhesion (VMA) can lead to vitreomacular traction (VMT) and macular hole (MH) formation, and is also associated with a worse prognosis in certain major eye conditions, including diabetic macular edema and age related macular degeneration.
MéthodesThis Phase III clinical trial is a randomized double-masked trial with control placebo injection. In total, 652 patients with decreased visual acuity and VMA (VMT or MH formation) were included. Patients were randomized to either receive a 125 µg microplasmin injection or a placebo (saline) injection.
RésultatsThe trials met its primary endpoint, a statistically significant improvement in the resolution of VMA. The results showed that 26.4% of the 465 microplasmin treated patients achieved resolution of the VMA at 28 days, compared to 10.2% of the 182 patients who received a placebo injection (p=0.000002). In patients diagnosed with MH, 40.6% of the 106 patients saw closure of the hole at 28 days following a single 125μg injection of microplasmin without the need for a vitrectomy. This compares with 10.6% of the 47 patients in the placebo group (p=0.00015). The closure of FTMH also led to microplasmin treated patients experiencing a significant improvement in their visual acuity (VA) and quality of life compared to placebo.
ConclusionThis phase III clinical trial showed that microplasmin:
- Was successful in nonsurgical resolution of vitreomacular adhesion
- Was able to cure macular holes without the need for surgery
- Delivered an improvement in the vision of patients without the need for surgery
- Was generally safe and well tolerated
Auteur 1
NomSTALMANS
InitialesP
InstitutDept. Ophthalmology UZLeuven
VilleLeuven
Auteur 2
NomMIVI-Trust Study Group
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