Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

Overview

The purpose of this study is to evaluate in a prospective study the efficacy of intravitreal autologous plasmin enzyme in macular edema and to analyze the fibrinolytic system in vitreous body.

Full Title of Study: “Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

Detailed Description

Autologous plasmin enzyme has been used to liquefy the gel structure of the vitreous body and to decrease the adherence of the posterior vitreous cortex to the inner limiting membrane in clinical studies. The investigators performed intravitreal autologous plasmin enzyme for macular edema. in addition, the investigators collected vitreous body in macular edema and analyzed fibrinolytic system.

Interventions

  • Procedure: Intravitreal injection
    • autologous plasmin was prepared in the operation department. Samples (3.5 mL) of autologous whole blood, collected by sterile vacuum blood collection tubes, were obtained from a peripheral vein. The blood was centrifuged at 4,000 rounds per minute for 15 minutes to obtain complete sedimentation of the cells; 1.5 mL of the plasma was aspirated and transferred under sterile conditions in a vial of urokinase(10,000 IU) that had been incubated for 15 minutes at 37°C. By gently moving the vial for 5 minutes, the solution was incubated for 15 minutes at 37°C; 0.2 mL of the obtained solution was used for intravitreal injection.

Arms, Groups and Cohorts

  • Experimental: Plasmin
    • eyes with macular edema

Clinical Trial Outcome Measures

Primary Measures

  • Central macular thickness after intravitreal autologous plasmin injection
    • Time Frame: 1 month after intervention
    • Central macular thickness measured by optocal coherence tompgraphy
  • Visual acuity after intravitreal autologous plasmin
    • Time Frame: 1 Month after intervention
    • logMAR visual acuity

Secondary Measures

  • fibrinolytic system
    • Time Frame: baseline
    • plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin

Participating in This Clinical Trial

Inclusion Criteria

  • eyes with macular edema
  • those who showed poor outcomes in visual acuity or macular thickness after grid laser,triamcinolone,or bevacizumab therapy or a combination of these treatments.

Exclusion Criteria

  • uncontrolled blood pressure (systolic and diastolic blood pressure greater than 150 and 90 mm Hg, respectively)
  • renal insufficiency
  • intraocular surgery or any intravitreal treatment during the previous 3 months
  • history of ocular hypertension and/or glaucoma

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hallym University Medical Center
  • Collaborator
    • Hallym University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jiwon Lim, MD PhD – Hallym University Medical Center
  • Overall Official(s)
    • Jiwon Lim, MDPhD, Principal Investigator, Chuncheon Sacred Heart Hospital
  • Overall Contact(s)
    • JiWOn Lim, MDPhD, 82-33-240-5176, jiwoneye@hallym.or.kr

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