Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

Not Applicable

• Conditions: Macular Edema
• Interventions: Procedure: Intravitreal injection

• Registration Number: NCT01478516
• Lead Sponsor: Hallym University Medical Center

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-01
• Last Update Posted: 2011-12-02
• Primary Completion: 2012-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plasmin	Intravitreal injection	eyes with macular edema

Primary Outcome Measures

Name	Time	Method
Visual acuity after intravitreal autologous plasmin	1 Month after intervention	logMAR visual acuity
Central macular thickness after intravitreal autologous plasmin injection	1 month after intervention	Central macular thickness measured by optocal coherence tompgraphy

Secondary Outcome Measures

Name	Time	Method
fibrinolytic system	baseline	plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin

Trial Locations

Locations (1)

Ji Won Lim; 🇰🇷 Chuncheon, Kangwon-do, Korea, Republic of