A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
- Conditions
- Vitrectomy
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- Patients in whom vitrectomy is indicated
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Retina Centers, P.C.
🇺🇸Tucson, Arizona, United States
VMR Institute
🇺🇸Huntington Beach, California, United States
Jules Stein Eye Institute/UCLA
🇺🇸Los Angeles, California, United States
Retinal Consultants of San Diego
🇺🇸Poway, California, United States
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States
National Ophtlamic Research Institute
🇺🇸Ft. Meyers, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Rush University Med. Ctr
🇺🇸Chicago, Illinois, United States
Mailing add: New England Eye Center - Tufts
🇺🇸Boston, Massachusetts, United States
Associated Retinal Consultants, P.C.
🇺🇸Royal Oak, Michigan, United States
Scroll for more (10 remaining)Retina Centers, P.C.🇺🇸Tucson, Arizona, United States