Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy
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ClinicalTrials.gov Identifier: NCT01478516 |
Recruitment Status
: Unknown
Verified December 2011 by Jiwon Lim, Hallym University Medical Center.
Recruitment status was: Recruiting
First Posted
: November 23, 2011
Last Update Posted
: December 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Macular Edema | Procedure: Intravitreal injection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | November 2012 |
Estimated Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Plasmin
eyes with macular edema
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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.
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- Central macular thickness after intravitreal autologous plasmin injection [ Time Frame: 1 month after intervention ]Central macular thickness measured by optocal coherence tompgraphy
- Visual acuity after intravitreal autologous plasmin [ Time Frame: 1 Month after intervention ]logMAR visual acuity
- fibrinolytic system [ Time Frame: baseline ]plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478516
Contact: JiWOn Lim, MDPhD | 82-33-240-5176 | jiwoneye@hallym.or.kr |
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 jiwoneye@hallym.or.kr |
Principal Investigator: | Jiwon Lim, MDPhD | Chuncheon Sacred Heart Hospital |
Responsible Party: | Jiwon Lim, MD PhD, Hallym University Medical Center |
ClinicalTrials.gov Identifier: | NCT01478516 History of Changes |
Other Study ID Numbers: |
2011-72 |
First Posted: | November 23, 2011 Key Record Dates |
Last Update Posted: | December 2, 2011 |
Last Verified: | December 2011 |
Keywords provided by Jiwon Lim, Hallym University Medical Center:
autologous plasmin macular edema vitreous |
Additional relevant MeSH terms:
Edema Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases |
Eye Diseases Fibrinolysin Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |