A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)

ThromboGenics51 enrolled

Overview

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

ocriplasminDRUG

Intravitreal injection, single administration

Sham injectionOTHER

Sham intravitreal injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria include: * patients \>18 years of age with Diabetic Macular Edema Exclusion Criteria include: * PVD present at baseline * Vitreous hemorrhage * Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR) * Patients who have had a vitrectomy in the study eye at any time

Locations (15)

ZNA OCMW Antwerpen

Antwerp, Belgium

University Hospital of Ghent

Ghent, Belgium

University Hospital Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

PVD Induction

The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)

Time frame: Day 14 post-injection

Data from ClinicalTrials.gov

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