A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With DME - Tabular View

Tracking Information

First Received Date ^ICMJE

December 14, 2006

Last Updated Date

April 2, 2009

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PVD induction [ Time Frame: Day 14 post-injection ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

PVD induction

Change History

Complete list of historical versions of study NCT00412451 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

measures of disease status and safety [ Time Frame: 6 months post-injection ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Clinical assessments

Descriptive Information

Brief Title ^ICMJE

A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With DME

Official Title ^ICMJE

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical PVD Induction for Treatment of Diabetic Macular Edema.

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Macular Edema

Intervention ^ICMJE

Drug: Microplasmin
Other: Sham injection

Study Arms / Comparison Groups

Sham Comparator: Sham injection

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00412451

Responsible Party

Edith Van Dijkman, ThromboGenics

Study ID Numbers ^ICMJE

TG-MV-002

Study Sponsor ^ICMJE

ThromboGenics

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Anselm Kampik, Prof. Dr.

LMU Augenklinik Munich - Germany

Information Provided By

ThromboGenics

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP