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

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

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

Study Overview

• Status: Completed
• Conditions: Vitrectomy
• Intervention / Treatment: Drug: Ocriplasmin 25µg; Drug: Ocriplasmin 75µg; Drug: Ocriplasmin 125µg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Microplasmin
Placebo Comparator: Placebo; Intravitreal injection of placebo	Drug: Placebo; Intravitreal injection of placebo
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 Names: 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 Names: Microplasmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect	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.	Day 7

Collaborators and Investigators

• Sponsor: ThromboGenics

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: December 18, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (Estimate): December 19, 2006

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Plasminogen; Fibrinolysin
• Other Study ID Numbers: TG-MV-003