Last reviewed · How we verify
An Open-Label, Ascending-Exposure-Time, Single Center Trial to Evaluate the Pharmacokinetic Properties of Ocriplasmin (Generic Name of the Molecule Microplasmin) Intravitreal Injection in Subjects Scheduled for Primary Pars Plana Vitrectomy (MIVI-10)
To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)
Details
| Lead sponsor | ThromboGenics |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 38 |
| Start date | 2010-07 |
| Completion | 2011-01 |
Conditions
- Vitrectomy
Interventions
- ocriplasmin
- ocriplasmin
- ocriplasmin
- ocriplasmin
- ocriplasmin
Primary outcomes
- Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy. — 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection
Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 \[5-30 minutes\]; Group 2 \[31-60 minutes\]; Group 3 \[2-4 hours\]; Group 4 \[24 hours ±2 hours\]; Group 5 \[7 days ±1 day\]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.
Countries
Belgium