Phase 2
N=125
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
Vitrectomy
Bottom Line
View on ClinicalTrials.gov: NCT00412958 ↗Enrolled (actual)
125
Serious AEs
5.6%
Results posted
Jan 2013
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ocriplasmin 25µg (Drug); Ocriplasmin 75µg (Drug); Ocriplasmin 125µg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ThromboGenics
- Primary completion
- Oct 2008
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 |
Summary
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
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.