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

Diabetic Macular Edema Clinical Trial

— MIVI-II  

Official title:

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of DME.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412451
• Other study ID #: TG-MV-002
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2006
• Last updated: December 2, 2014
• Start date: December 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBelgium: Ministry of Social Affairs, Public Health and the EnvironmentNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• ocriplasmin
Intravitreal injection, single administration

Other:
• Sham injection
Sham intravitreal injection

Locations

Country	Name	City	State
Belgium	ZNA OCMW Antwerpen	Antwerpen
Belgium	University Hospital of Ghent	Ghent
Belgium	University Hospital Leuven	Leuven
Germany	Ludwig Maximillian University	Munich
Italy	University of Milan	Milan
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart	Rome
Italy	Ospedale di Circolo di Varese, Insubria University	Varese
Netherlands	Academic Hospital Groningen	Groningen
Netherlands	Het Oogziekenhuis Rotterdam	Rotterdam
Spain	Hospital Vall D'Hebron	Barcelona
Spain	Institut de Microcirurgia Ocular de Barcelona	Barcelona
Spain	Instituto Technologico de Oftalmologia SL.	Santiago de Compostela
United Kingdom	Royal Liverpool & Broadgreen Hospital	Liverpool
United Kingdom	Moorfields Eye Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 14 post-injection	No