A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III) - Full Text View

Sponsored by:	ThromboGenics
Information provided by:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00412958

Purpose

A multicenter study to compare multiple doses of intravitreal miscroplasm in patients undergoing surgical vitrectomy.

Condition	Intervention	Phase
Vitreoretinal Disorders	Drug: Microplasmin	Phase II

Drug Information available for: Microplasmin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

PVD Induction [ Time Frame: Baseline, Injection day, post-injection Day-3, Operative day, Day-90 and Day-180 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post injection and post-operative complications [ Time Frame: Operative day, Day-1, Day-7, Day-14, Day-28, Day-90 and Day-180 ] [ Designated as safety issue: Yes ]

Enrollment:	125
Study Start Date:	December 2006
Estimated Study Completion Date:	January 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Microplasmin Midvitreous injection of 0.1 ml of microplasmin solution containing 25, 75 and 125ug of microplasmin.
2: Experimental	Drug: Microplasmin Midvitreous injection of 0.1 ml of microplasmin solution containing 25, 75 and 125ug of microplasmin.
3: Experimental	Drug: Microplasmin Midvitreous injection of 0.1 ml of microplasmin solution containing 25, 75 and 125ug of microplasmin.
4: Placebo Comparator	Drug: Microplasmin Midvitreous injection of 0.1 ml of placebo solution

Eligibility

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

Criteria

Inclusion Criteria:

Patients in whom vitrectomy is indicated

Exclusion Criteria:

PVD present at baseline
Vitreous hemorrhage
Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
Have had a vitrectomy in the study eye at any time

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412958

Locations

United States, Arizona
Retina Centers, P.C.
Tucson, Arizona, United States, 85704
United States, California
Retinal Consultants of San Diego
Poway, California, United States, 92064
Jules Stein Eye Institute/UCLA
Los Angeles, California, United States, 90095
VMR Institute
Huntington Beach, California, United States, 92647
Retinal Consultants Medical Group
Sacramento, California, United States, 95819
United States, Florida
National Ophtlamic Research Institute
Ft. Meyers, Florida, United States, 33912
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Illinois
Rush University Med. Ctr
Chicago, Illinois, United States, 60612
United States, Massachusetts
Mailing add: New England Eye Center - Tufts
Boston, Massachusetts, United States, 02111
United States, Michigan
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Vitroretinal Surgery, PA
Minneapolis, Minnesota, United States, 55435
United States, New Jersey
Retina Vitreous Centre, PA
New Brunswick, New Jersey, United States, 08901
United States, New York
Columbia University - Harkness Eye Institute
New York, New York, United States, 10032
Retina Vitreous Surgeons of Central NY
New York, New York, United States, 13224
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
United States, Ohio
Retina Association of Cleveland
Lakewood, Ohio, United States, 44107
United States, Pennsylvania
Allegheny Ophthalmic & Orbital Associates, P.C.
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232-8808
United States, Texas
Vitreoretinal Consultants
Houston, Texas, United States, 77030
Valley Retina Institute, P.A.
McAllen, Texas, United States, 78503

Sponsors and Collaborators

ThromboGenics

Investigators

Principal Investigator:

Matthew Benz, MD

Vitreoretinal Consultants

More Information

Responsible Party:	ThromboGenics ( Donna Benzer/Associate Director, Clinical Development )
Study ID Numbers:	TG-MV-003
Study First Received:	December 18, 2006
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00412958
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vitreous Detachment
Eye Diseases

ClinicalTrials.gov processed this record on January 14, 2009