Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy
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.
|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|
- 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
- fibrinolytic system [ Time Frame: baseline ] [ Designated as safety issue: Yes ]plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin
|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)|
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.
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.
|Contact: JiWOn Lim, MDPhDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Jiwon Lim, MDPhD||Chuncheon Sacred Heart Hospital|