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Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Macular Edema Procedure: Intravitreal injection

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 Design

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
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01478516


Contacts
Contact: JiWOn Lim, MDPhD 82-33-240-5176 jiwoneye@hallym.or.kr

Locations
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    jiwoneye@hallym.or.kr   
Sponsors and Collaborators
Hallym University Medical Center
Hallym University
Investigators
Principal Investigator: Jiwon Lim, MDPhD Chuncheon Sacred Heart Hospital
More Information

Responsible Party: Jiwon Lim, MD PhD, Hallym University Medical Center
ClinicalTrials.gov 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
vitreous

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