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

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ClinicalTrials.gov Identifier: NCT00412958
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : January 30, 2013
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

Condition or disease Intervention/treatment Phase
Vitrectomy Drug: Ocriplasmin 25µg Drug: Ocriplasmin 75µg Drug: Ocriplasmin 125µg Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2006
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect [ Time Frame: Day 7 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
More Information

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00412958     History of Changes
Other Study ID Numbers: TG-MV-003
First Posted: December 19, 2006    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: December 17, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Vitreous Detachment
Eye Diseases
Fibrinolysin
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action