Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

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. Identifier: NCT01478516
Recruitment Status : Unknown
Verified December 2011 by Jiwon Lim, Hallym University Medical Center.
Recruitment status was:  Recruiting
First Posted : November 23, 2011
Last Update Posted : December 2, 2011
Hallym University
Information provided by (Responsible Party):
Jiwon Lim, Hallym University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Macular Edema Procedure: Intravitreal injection Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema
Study Start Date : November 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Plasmin
eyes with macular edema
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.

Primary Outcome Measures :
  1. Central macular thickness after intravitreal autologous plasmin injection [ Time Frame: 1 month after intervention ]
    Central macular thickness measured by optocal coherence tompgraphy

  2. Visual acuity after intravitreal autologous plasmin [ Time Frame: 1 Month after intervention ]
    logMAR visual acuity

Secondary Outcome Measures :
  1. fibrinolytic system [ Time Frame: baseline ]
    plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478516

Contact: JiWOn Lim, MDPhD 82-33-240-5176

Korea, Republic of
Ji Won Lim Recruiting
Chuncheon, Kangwon-do, Korea, Republic of, 200-704
Contact: Jj Won Lim, MD PhD    82-33-240-5176   
Sponsors and Collaborators
Hallym University Medical Center
Hallym University
Principal Investigator: Jiwon Lim, MDPhD Chuncheon Sacred Heart Hospital

Responsible Party: Jiwon Lim, MD PhD, Hallym University Medical Center Identifier: NCT01478516     History of Changes
Other Study ID Numbers: 2011-72
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011

Keywords provided by Jiwon Lim, Hallym University Medical Center:
autologous plasmin
macular edema

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action