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

Tracking Information

First Received Date ^ICMJE

November 17, 2011

Last Updated Date

December 1, 2011

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01478516 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

fibrinolytic system [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

Official Title ^ICMJE

Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Macular Edema

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Plasmin

eyes with macular edema

Intervention: Procedure: Intravitreal injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2013

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: JiWOn Lim, MDPhD

82-33-240-5176

jiwoneye@hallym.or.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01478516

Other Study ID Numbers ^ICMJE

2011-72

Has Data Monitoring Committee

Yes

Responsible Party

Jiwon Lim, Hallym University Medical Center

Study Sponsor ^ICMJE

Hallym University Medical Center

Collaborators ^ICMJE

Hallym University

Investigators ^ICMJE

Principal Investigator:

Jiwon Lim, MDPhD

Chuncheon Sacred Heart Hospital

Information Provided By

Hallym University Medical Center

Verification Date

December 2011

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

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