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

November 17, 2011
November 23, 2011
December 2, 2011
November 2011
November 2012   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01478516 on Archive Site
fibrinolytic system [ Time Frame: baseline ]
plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin
Same as current
Not Provided
Not Provided
Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy
Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Experimental: Plasmin
eyes with macular edema
Intervention: Procedure: Intravitreal injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
November 2013
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Jiwon Lim, Hallym University Medical Center
Hallym University Medical Center
Hallym University
Principal Investigator: Jiwon Lim, MDPhD Chuncheon Sacred Heart Hospital
Hallym University Medical Center
December 2011

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