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NCT00412958 Clinical Trial

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

Vitrectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00412958
Other study ID # TG-MV-003
Secondary ID
Status Completed
Phase Phase 2
First received December 18, 2006
Last updated December 2, 2014
Start date December 2006
Est. completion date October 2008

Study information
Verified date April 2014
Source ThromboGenics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Ocriplasmin 25µg
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.
• Ocriplasmin 75µg
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.
• Ocriplasmin 125µg
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.
• Placebo
Intravitreal injection of placebo

Locations
Country Name City State
United States Mailing add: New England Eye Center - Tufts Boston Massachusetts
United States Rush University Med. Ctr Chicago Illinois
United States Duke Eye Center Durham North Carolina
United States National Ophtlamic Research Institute Ft. Meyers Florida
United States Vitreoretinal Consultants Houston Texas
United States VMR Institute Huntington Beach California
United States Retina Association of Cleveland Lakewood Ohio
United States Jules Stein Eye Institute/UCLA Los Angeles California
United States Valley Retina Institute, P.A. McAllen Texas
United States Vitroretinal Surgery, PA Minneapolis Minnesota
United States Vanderbilt Eye Institute Nashville Tennessee
United States Retina Vitreous Centre, PA New Brunswick New Jersey
United States Columbia University - Harkness Eye Institute New York New York
United States Retina Vitreous Surgeons of Central NY New York New York
United States Allegheny Ophthalmic & Orbital Associates, P.C. Pittsburgh Pennsylvania
United States Retinal Consultants of San Diego Poway California
United States Associated Retinal Consultants, P.C. Royal Oak Michigan
United States Retinal Consultants Medical Group Sacramento California
United States Retina Centers, P.C. Tucson Arizona
United States Center for Retina and Macular Disease Winter Haven Florida

Sponsors (1)
Lead Sponsor Collaborator
ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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