Phase 2
Completed N=125
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
Vitrectomy
Source: ClinicalTrials.gov NCT00412958 ↗
Enrolled (actual)
125
Serious AEs
5.6%
Results posted
Jan 2013
Primary outcomePrimary: Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect — 13.8; 18.2; 31.3; 10 percentage of participants — p=0.796
Summary
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect |
13.8; 18.2; 31.3; 10 | 0.796 |
Eligibility Criteria
Inclusion Criteria
- Patients in whom vitrectomy is indicated
Exclusion Criteria
- Posterior Vitreous Detachment (PVD) present at baseline
- Vitreous hemorrhage
- Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- Have had a vitrectomy in the study eye at any time
Data sourced from ClinicalTrials.gov (NCT00412958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.