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

NCT ID: NCT00412451

Last Updated: 2014-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-03-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Macular Edema

Keywords

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Diabetic Macular Edema PVD DME Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ocriplasmin 25µg

25µg ocriplasmin intravitreal injection versus sham injection

Group Type EXPERIMENTAL

ocriplasmin

Intervention Type DRUG

Intravitreal injection, single administration

Ocriplasmin 75µg

75µg ocriplasmin intravitreal injection versus sham injection

Group Type EXPERIMENTAL

ocriplasmin

Intervention Type DRUG

Intravitreal injection, single administration

Ocriplasmin 125µg

125µg ocriplasmin intravitreal injection versus sham injection

Group Type EXPERIMENTAL

ocriplasmin

Intervention Type DRUG

Intravitreal injection, single administration

sham injection

Sham injection

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type OTHER

Sham intravitreal injection

Interventions

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ocriplasmin

Intravitreal injection, single administration

Intervention Type DRUG

Sham injection

Sham intravitreal injection

Intervention Type OTHER

Other Intervention Names

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microplasmin

Eligibility Criteria

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Inclusion Criteria

* patients \>18 years of age with Diabetic Macular Edema

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ThromboGenics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ZNA OCMW Antwerpen

Antwerp, , Belgium

Site Status

University Hospital of Ghent

Ghent, , Belgium

Site Status

University Hospital Leuven

Leuven, , Belgium

Site Status

Ludwig Maximillian University

Munich, , Germany

Site Status

University of Milan

Milan, , Italy

Site Status

Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Site Status

Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart

Rome, , Italy

Site Status

Ospedale di Circolo di Varese, Insubria University

Varese, , Italy

Site Status

Academic Hospital Groningen

Groningen, , Netherlands

Site Status

Het Oogziekenhuis Rotterdam

Rotterdam, , Netherlands

Site Status

Institut de Microcirurgia Ocular de Barcelona

Barcelona, , Spain

Site Status

Hospital Vall D'Hebron

Barcelona, , Spain

Site Status

Instituto Technologico de Oftalmologia SL.

Santiago de Compostela, , Spain

Site Status

Royal Liverpool & Broadgreen Hospital

Liverpool, , United Kingdom

Site Status

Moorfields Eye Hospital

London, , United Kingdom

Site Status

Countries

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Ireland Belgium Germany Italy Netherlands Spain United Kingdom

Other Identifiers

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TG-MV-002

Identifier Type: -

Identifier Source: org_study_id