Phase 2
Completed N=60
A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)
Vitreomacular Traction
Source: ClinicalTrials.gov NCT00435539 ↗
Enrolled (actual)
60
Serious AEs
20.0%
Results posted
Sep 2013
Primary outcomePrimary: Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. — 18.2; 18.2; 13.6; 0 percentage of participants — p=0.4762
Summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. |
18.2; 18.2; 13.6; 0 | 0.4762 |
| SECONDARY Resolution of Vitreomacular Traction (Investigator's Assessment) |
25; 27.3; 11; 8.3 | 0.4783 |
Eligibility Criteria
Inclusion Criteria
- Patients >\_ 18 years of age with vitreomacular traction
Exclusion Criteria
- PVD present at baseline
- Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- Vitreous hemorrhage
- Patients who have had a vitrectomy in the study eye at any time
Data sourced from ClinicalTrials.gov (NCT00435539). 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.