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OpenTrials
Completed

NCT Number: NCT00123279

Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Gasthuisberg, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microplasmin

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. The occurrence of any (serious) adverse event

    Time frame: Throught-out the study

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study title

A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Jul 22, 2005
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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