Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hallym University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hallym University
Information provided by (Responsible Party):
Jiwon Lim, Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01478516
First received: November 17, 2011
Last updated: December 1, 2011
Last verified: December 2011

November 17, 2011
December 1, 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 ] [ Designated as safety issue: Yes ]
    Central macular thickness measured by optocal coherence tompgraphy
  • Visual acuity after intravitreal autologous plasmin [ Time Frame: 1 Month after intervention ] [ Designated as safety issue: Yes ]
    logMAR visual acuity
Same as current
Complete list of historical versions of study NCT01478516 on ClinicalTrials.gov Archive Site
fibrinolytic system [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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
Both
20 Years to 80 Years
No
Contact: JiWOn Lim, MDPhD 82-33-240-5176 jiwoneye@hallym.or.kr
Korea, Republic of
 
NCT01478516
2011-72
Yes
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