Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy

• ClinicalTrials.gov Identifier: NCT00123279
• Recruitment Status: Completed
• First Posted: July 22, 2005
• Last Update Posted: April 7, 2014
• Sponsor: ThromboGenics
• Information provided by: ThromboGenics

Tracking Information

• First Submitted Date: July 21, 2005
• First Posted Date: July 22, 2005
• Last Update Posted Date: April 7, 2014
• Study Start Date: December 2004
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: July 21, 2005)

• Safety
• PVD induction

• Current Secondary Outcome Measures (submitted: November 25, 2008): The occurrence of any (serious) adverse event [ Time Frame: Throught-out the study ]
• Original Secondary Outcome Measures (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: Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Vitreomacular Traction Maculopathy
• Eye Diseases

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 21, 2005): 60
• Original Enrollment: Same as current
• Actual Study Completion Date: November 2008
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Netherlands
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT00123279
• Other Study ID Numbers: TG-MV-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Edith Van Dijkman, ThromboGenics
• Study Sponsor: ThromboGenics
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marc deSmet, Prof. Dr; VU University Medical Center

• PRS Account: ThromboGenics
• Verification Date: April 2014