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

Vitreomacular Traction Clinical Trial

Official title:

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435539
• Other study ID #: TG-MV-004
• Secondary ID: MIVI-IIT
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2007
• Last updated: December 2, 2014
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitreomacular Traction

Intervention

Drug:
• ocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
• ocriplasmin
Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.
• Sham Comparator
Intravitreal sham injection

Locations

Country	Name	City	State
Belgium	ZNA OCMW Antwerpen	Antwerpen
Belgium	University Hospital of Ghent	Ghent
Belgium	Universitaire Ziekenhuizen K.U.Leuven	Leuven
Germany	Augenklinik der Universitat Munchen	Munchen

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.		Day 14	No
Secondary	Resolution of Vitreomacular Traction (Investigator's Assessment)	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.	Day 28	No