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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00412958
First received: December 18, 2006
Last updated: April 4, 2014
Last verified: April 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Retina Vitreous Surgeons of Central NY
New York, New York, United States, 13224
Columbia University - Harkness Eye Institute
New York, New York, United States, 10032
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

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: April 4, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014