drugset / Trial / NCT00435539
A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)
RandomizedParallel-groupDouble-blindTreatment
Summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
Timeline
- Start
- 2007-02
- Primary completion
- 2009-01
- Completion
- 2009-02
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Ocriplasmin 75µg Single Injection vs Sham Injection; p = 0.4762; Fisher Exact NCT00435539 ↗
registry analysis (superiority or other test); Ocriplasmin 175µg Single Injection vs Sham Injection; p = 0.4762; Fisher Exact NCT00435539 ↗
registry analysis (superiority or other test); Ocriplasmin 125µg Pooled vs Sham Injection; p = 0.5343; Fisher Exact NCT00435539 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocriplasmin | Protein / enzyme biologic | 75 ug | Intravitreal |
| Subject | Ocriplasmin | Protein / enzyme biologic | 125 ug | Intravitreal |