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Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123279
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : April 7, 2014
Sponsor:
Information provided by:
ThromboGenics

Tracking Information
First Submitted Date  ICMJE July 21, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE December 2004
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
  • Safety
  • PVD induction
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
The occurrence of any (serious) adverse event [ Time Frame: Throught-out the study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
Best-corrected visual acuity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
Official Title  ICMJE A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitreomacular Traction Maculopathy
  • Eye Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Microplasmin
  • Experimental: 2
    Intervention: Drug: Microplasmin
  • Experimental: 3
    Intervention: Drug: Microplasmin
  • Experimental: 4
    Intervention: Drug: Microplasmin
  • Experimental: 5
    Intervention: Drug: Microplasmin
  • Experimental: 6
    Intervention: Drug: Microplasmin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT00123279
Other Study ID Numbers  ICMJE TG-MV-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edith Van Dijkman, ThromboGenics
Study Sponsor  ICMJE ThromboGenics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc deSmet, Prof. Dr VU University Medical Center
PRS Account ThromboGenics
Verification Date April 2014

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