Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

Hallym University

Status: Unknown

Conditions: Macular Edema

Treatments: Procedure: Intravitreal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01478516

2011-72

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Plasmin

Experimental group

Description:

eyes with macular edema

Treatment:

Procedure: Intravitreal injection