Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

Study Overview
=================
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.

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

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Procedure: Intravitreal injection


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasmin<br>eyes with macular edema | Procedure: Intravitreal injection<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness after intravitreal autologous plasmin injection | Central macular thickness measured by optocal coherence tompgraphy | 1 month after intervention | 
| Visual acuity after intravitreal autologous plasmin | logMAR visual acuity | 1 Month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibrinolytic system | plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous plasmin, macular edema, vitreous