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

Sponsor:	ThromboGenics
Information provided by:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00435539

Purpose

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

Condition	Intervention	Phase
Vitreomacular Traction	Drug: Microplasmin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Microplasmin

U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	90
Study Start Date:	February 2007
Study Completion Date:	February 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Microplasmin Midvitreous injection of microplasmin solution containing 75, 125 and 175 ug of microplasmin.
2: Experimental	Drug: Microplasmin Midvitreous injection of microplasmin solution containing 75, 125 and 175 ug of microplasmin.
3: Experimental	Drug: Microplasmin Midvitreous injection of microplasmin solution containing 75, 125 and 175 ug of microplasmin.
4: Experimental	Drug: Microplasmin Midvitreous injection of microplasmin solution containing 125ug of microplasmin with up to 2 additional (open lable) 125ug microplasmin injection at 1 month interval.
5: Sham Comparator	Drug: Microplasmin Midvitreous sham injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435539

Locations

Belgium
ZNA OCMW Antwerpen
Antwerpen, Belgium, 2020
Universitaire Ziekenhuizen K.U.Leuven
Leuven, Belgium
University Hospital of Ghent
Ghent, Belgium, B-9000
Germany
Augenklinik der Universitat Munchen
Munchen, Germany, 80336

Sponsors and Collaborators

ThromboGenics

Investigators

Principal Investigator:

Peter Stalmans, Prof. Dr.

UZ KULeuven, St. Rafaël Hospital, Leuven Belgium

More Information

No publications provided

Responsible Party:	ThromboGenics ( Edith Van Dijkman )
Study ID Numbers:	TG-MV-004, MIVI-IIT
Study First Received:	February 14, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00435539 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ThromboGenics:

Vitreomacular Traction
Maculopathy
VMT
PVD

ClinicalTrials.gov processed this record on November 09, 2009