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

Tracking Information

First Received Date ^ICMJE

February 14, 2007

Last Updated Date

April 30, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of patients with total PVD [ Time Frame: Baseline, Injection day, Post-injection Day-3, Day-7, Day-14, Day-28, Month-3 and Month-6. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

PVD induction

Change History

Complete list of historical versions of study NCT00435539 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

History/full ophthalmologic examination [ Time Frame: Baseline, post-injection Day-3, Day-7, Day-14, Day-28 and post-injection Month-3 and Month-6 after the last injection of the 4th cohort. ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Clinical assessments

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical PVD Induction for Treatment of Vitreomacular Traction

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vitreomacular Traction

Intervention ^ICMJE

Drug: Microplasmin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Germany

Administrative Information

NCT ID ^ICMJE

NCT00435539

Responsible Party

Edith Van Dijkman, ThromboGenics

Study ID Numbers ^ICMJE

TG-MV-004, MIVI-IIT

Study Sponsor ^ICMJE

ThromboGenics

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Peter Stalmans, Prof. Dr.

UZ KULeuven, St. Rafaël Hospital, Leuven Belgium

Information Provided By

ThromboGenics

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP