Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01478516
• Other study ID #: 2011-72
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2011
• Last updated: December 1, 2011
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: December 2011
• Source: Hallym University Medical Center
• Contact: JiWOn Lim, MDPhD
• Phone: 82-33-240-5176
• Email: jiwoneye[@]hallym.or.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ji Won Lim	Chuncheon	Kangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Hallym University Medical Center	Hallym University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness after intravitreal autologous plasmin injection	Central macular thickness measured by optocal coherence tompgraphy	1 month after intervention	Yes
Primary	Visual acuity after intravitreal autologous plasmin	logMAR visual acuity	1 Month after intervention	Yes
Secondary	fibrinolytic system	plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin	baseline	Yes