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

Purpose

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

Condition	Intervention	Phase
Vitrectomy	Drug: Ocriplasmin 25µg Drug: Ocriplasmin 75µg Drug: Ocriplasmin 125µg Drug: Placebo	Phase 2

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

Resource links provided by NLM:

Drug Information available for: Ocriplasmin

U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.

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

Arms	Assigned Interventions
Experimental: Ocriplasmin 25µg 25µg of ocriplasmin intravitreal injection	Drug: Ocriplasmin 25µg Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin. Other Name: Microplasmin
Experimental: Ocriplasmin 75µg 75µg of ocriplasmin intravitreal injection	Drug: Ocriplasmin 75µg Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin. Other Name: Microplasmin
Experimental: Ocriplasmin 125µg 125µg of ocriplasmin intravitreal injection	Drug: Ocriplasmin 125µg Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin. Other Name: Microplasmin
Placebo Comparator: Placebo Intravitreal injection of placebo	Drug: Placebo Intravitreal injection of placebo

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:

Posterior Vitreous Detachment (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
VMR Institute
Huntington Beach, California, United States, 92647
Jules Stein Eye Institute/UCLA
Los Angeles, California, United States, 90095
Retinal Consultants of San Diego
Poway, California, United States, 92064
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

No publications provided

Responsible Party:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00412958 History of Changes
Other Study ID Numbers:	TG-MV-003
Study First Received:	December 18, 2006
Results First Received:	December 20, 2012
Last Updated:	January 30, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vitreous Detachment
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013