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

Phase 2

Completed

• Conditions: Vitreomacular Traction
• Interventions: Drug: ocriplasmin; Drug: Sham Comparator

• Registration Number: NCT00435539
• Lead Sponsor: ThromboGenics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Results First Submitted: 2013-07-04
• Results First Submitted QC: 2013-07-04
• Results First Posted: 2013-09-13
• Status Verified: 2014-04
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ocriplasmin 75µg single injection	ocriplasmin	Ocriplasmin 75µg single injection versus sham injection
ocriplasmin 175µg single injection	ocriplasmin	Ocriplasmin 175µg single injection versus sham injection
ocriplasmin 125µg single injection	ocriplasmin	Ocriplasmin 125µg single injection versus sham injection
ocriplasmin 125µg multiple injections	ocriplasmin	Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg.
sham injection	Sham Comparator	sham injection

Primary Outcome Measures

Name	Time	Method
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.	Day 14

Secondary Outcome Measures

Name	Time	Method
Resolution of Vitreomacular Traction (Investigator's Assessment)	Day 28	Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.

Trial Locations

Locations (4)

ZNA OCMW Antwerpen; 🇧🇪 Antwerpen, Belgium

University Hospital of Ghent; 🇧🇪 Ghent, Belgium

Universitaire Ziekenhuizen K.U.Leuven; 🇧🇪 Leuven, Belgium

Augenklinik der Universitat Munchen; 🇩🇪 Munchen, Germany