Clinical trial NCT00412958: A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitrectomy
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Centers, P.C.
state: Arizona
city: Huntington Beach
country: United States
facility: VMR Institute
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute/UCLA
state: California
city: Poway
country: United States
facility: Retinal Consultants of San Diego
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Ft. Meyers
country: United States
facility: National Ophtlamic Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Chicago
country: United States
facility: Rush University Med. Ctr
state: Illinois
city: Boston
country: United States
facility: Mailing add: New England Eye Center - Tufts
state: Massachusetts
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Minneapolis
country: United States
facility: Vitroretinal Surgery, PA
state: Minnesota
city: New Brunswick
country: United States
facility: Retina Vitreous Centre, PA
state: New Jersey
city: New York
country: United States
facility: Columbia University - Harkness Eye Institute
state: New York
city: New York
country: United States
facility: Retina Vitreous Surgeons of Central NY
state: New York
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
city: Lakewood
country: United States
facility: Retina Association of Cleveland
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Ophthalmic & Orbital Associates, P.C.
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Houston
country: United States
facility: Vitreoretinal Consultants
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
Study officials:
References: