Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy - Full Text View

Sponsored by:	ThromboGenics
Information provided by:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00123279

Purpose

The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.

Condition	Intervention	Phase
Vitreomacular Traction Maculopathy Eye Diseases	Drug: Microplasmin	Phase II

MedlinePlus related topics: Eye Diseases

Drug Information available for: Microplasmin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Dose-Escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy

Further study details as provided by ThromboGenics:

Primary Outcome Measures:

Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction [ Time Frame: Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The occurrence of any (serious) adverse event [ Time Frame: Throught-out the study ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	December 2004
Study Completion Date:	November 2008
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Microplasmin 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
2: Experimental	Drug: Microplasmin 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
3: Experimental	Drug: Microplasmin 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
4: Experimental	Drug: Microplasmin 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
5: Experimental	Drug: Microplasmin 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
6: Experimental	Drug: Microplasmin 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.

Detailed Description:

Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated, according to the principal investigator, including:
- Macular edema associated with vitreomacular traction (DME, VMTS);
- Stage II-III macular hole of < 6 months duration since symptom onset;
- Demonstration of vitreomacular adhesion (based on preoperative optic coherence tomography [OCT]) in the study eye;
- OCT - presence of posterior hyaloid membrane inserting on to the macula, but with some area of clear separation visible between the retina and the posterior hyaloid.

Exclusion Criteria:

Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion).
Patients with vitreous hemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye.
Patients with rhegmatogenous retinal detachment, proliferative vitreoretinopathy (PVR), or retinal degenerative changes in the study eye.
Patients with high myopia or aphakia in the study eye
Patients with history of rhegmatogenous retinal detachment in the fellow eye or family history of retinal detachment
Patients who are considered likely to require intraocular surgery in the study eye for any reason other than vitreomacular traction maculopathy/macular edema in the coming three months.
Patients who have had ocular surgery in the study eye in the prior three months.
Patients who have had a vitrectomy in the study eye at any time.
Patients with a history of uveitis or significant trauma in the study eye.
Patients who are currently being treated for glaucoma in the study eye.
Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months.
Intravitreal injection of any drug in the study eye in the previous 6 months or during the study.
Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the investigator.
Patients who, in the investigator's view, will not complete all visits and investigations, including the exit visit at 6 months.
Patients who have participated in an investigational drug study within the past 30 days.
HgA1c > 9%.
Patients with hypertension (either systolic blood pressure [SBP] > 170 or diastolic blood pressure [DBP] > 100 mm Hg).
Patients with a life-expectancy less than 6 months.
Patients who have previously participated in this trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123279

Locations

Belgium
University Hospital Gasthuisberg
Leuven, Belgium, B-3000
Germany
Ludwig-Maximilians-University
Munich, Germany, D-80336
Netherlands
Oogziekenhuis Rotterdam
Rotterdam, Netherlands, 3011 BH
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands, 1105 AZ

Sponsors and Collaborators

ThromboGenics

Investigators

Principal Investigator:

Marc deSmet, Prof. Dr

Amsterdam Medical Center

More Information

Responsible Party:	ThromboGenics ( Edith Van Dijkman )
Study ID Numbers:	TG-MV-001
Study First Received:	July 21, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00123279
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ThromboGenics:

diabetic macular edema
macular hole
vitreomacular traction syndrome

Study placed in the following topic categories:

Macular Edema
Eye Diseases
Edema

ClinicalTrials.gov processed this record on January 16, 2009