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

Phase 2CompletedNCT00412958

ThromboGenics125 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

125

Conditions

Vitrectomy

Interventions

Ocriplasmin 25µgDRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.

Ocriplasmin 75µgDRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.

Ocriplasmin 125µgDRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Retina Centers, P.C.

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 7

Data from ClinicalTrials.gov

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