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

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:

MedlinePlus related topics: Edema

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.

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 30, 2016

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