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

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: ocriplasmin; Other: Sham injection

• Registration Number: NCT00412451
• Lead Sponsor: ThromboGenics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-18
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Results First Submitted: 2013-07-04
• Results First Submitted QC: 2013-07-04
• Results First Posted: 2013-09-13
• Status Verified: 2014-04
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ocriplasmin 25µg	ocriplasmin	25µg ocriplasmin intravitreal injection versus sham injection
Ocriplasmin 75µg	ocriplasmin	75µg ocriplasmin intravitreal injection versus sham injection
sham injection	Sham injection	Sham injection
Ocriplasmin 125µg	ocriplasmin	125µg ocriplasmin intravitreal injection versus sham injection

Primary Outcome Measures

Name	Time	Method
PVD Induction	Day 14 post-injection	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)

Trial Locations

Locations (15)

Instituto Technologico de Oftalmologia SL.; 🇪🇸 Santiago de Compostela, Spain

Academic Hospital Groningen; 🇳🇱 Groningen, Netherlands

Het Oogziekenhuis Rotterdam; 🇳🇱 Rotterdam, Netherlands

Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart; 🇮🇹 Rome, Italy

Ospedale di Circolo di Varese, Insubria University; 🇮🇹 Varese, Italy

Royal Liverpool & Broadgreen Hospital; 🇬🇧 Liverpool, United Kingdom

Hospital Vall D'Hebron; 🇪🇸 Barcelona, Spain

Institut de Microcirurgia Ocular de Barcelona; 🇪🇸 Barcelona, Spain

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

University of Milan; 🇮🇹 Milan, Italy

University Hospital Leuven; 🇧🇪 Leuven, Belgium

Ludwig Maximillian University; 🇩🇪 Munich, Germany

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, Italy

University Hospital of Ghent; 🇧🇪 Ghent, Belgium

ZNA OCMW Antwerpen; 🇧🇪 Antwerpen, Belgium