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Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

This study is currently recruiting participants.
Verified December 2011 by Hallym University Medical Center
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
History of Changes
  Purpose

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 Intervention
Macular Edema
 Procedure: Intravitreal injection

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • fibrinolytic system [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jiwon Lim, MD PhD, Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01478516     History of Changes
Other Study ID Numbers: 2011-72
Study First Received: November 17, 2011
Last Updated: December 1, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Hallym University Medical Center:
autologous plasmin
macular edema
vitreous

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Fibrinolysin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 19, 2013