Phase 2 N=60 Randomized Double-blind Treatment

A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

Vitreomacular Traction

Bottom Line

View on ClinicalTrials.gov: NCT00435539 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Sep 2013

Primary outcome: 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 percentage of participants — p=0.4762

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ocriplasmin (Drug); Sham Comparator (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ThromboGenics
Primary completion: Jan 2009

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

Summary

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

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

View full record on ClinicalTrials.gov →

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.