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

Phase 2

Completed

• Conditions: Vitrectomy
• Interventions: Drug: Ocriplasmin 75µg; Drug: Ocriplasmin 125µg; Drug: Placebo; Drug: Ocriplasmin 25µg

• Registration Number: NCT00412958
• Lead Sponsor: ThromboGenics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2012-12-20
• Results First Submitted QC: 2012-12-20
• Results First Posted: 2013-01-30
• Status Verified: 2014-04
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ocriplasmin 75µg	Ocriplasmin 75µg	75µg of ocriplasmin intravitreal injection
Ocriplasmin 125µg	Ocriplasmin 125µg	125µg of ocriplasmin intravitreal injection
Placebo	Placebo	Intravitreal injection of placebo
Ocriplasmin 25µg	Ocriplasmin 25µg	25µg of ocriplasmin intravitreal injection

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect	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.

Trial Locations

Locations (20)

Mailing add: New England Eye Center - Tufts; 🇺🇸 Boston, Massachusetts, United States

Associated Retinal Consultants, P.C.; 🇺🇸 Royal Oak, Michigan, United States

Allegheny Ophthalmic & Orbital Associates, P.C.; 🇺🇸 Pittsburgh, Pennsylvania, United States

Jules Stein Eye Institute/UCLA; 🇺🇸 Los Angeles, California, United States

Retina Centers, P.C.; 🇺🇸 Tucson, Arizona, United States

Retinal Consultants of San Diego; 🇺🇸 Poway, California, United States

Vanderbilt Eye Institute; 🇺🇸 Nashville, Tennessee, United States

Columbia University - Harkness Eye Institute; 🇺🇸 New York, New York, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

VMR Institute; 🇺🇸 Huntington Beach, California, United States

National Ophtlamic Research Institute; 🇺🇸 Ft. Meyers, Florida, United States

Center for Retina and Macular Disease; 🇺🇸 Winter Haven, Florida, United States

Retina Vitreous Centre, PA; 🇺🇸 New Brunswick, New Jersey, United States

Vitreoretinal Consultants; 🇺🇸 Houston, Texas, United States

Vitroretinal Surgery, PA; 🇺🇸 Minneapolis, Minnesota, United States

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States

Rush University Med. Ctr; 🇺🇸 Chicago, Illinois, United States

Retina Vitreous Surgeons of Central NY; 🇺🇸 New York, New York, United States

Valley Retina Institute, P.A.; 🇺🇸 McAllen, Texas, United States

Retina Association of Cleveland; 🇺🇸 Lakewood, Ohio, United States