Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy
Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 17, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 2, 2011
December 1, 2011
1 year
November 17, 2011
December 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
fibrinolytic system
baseline
Study Arms (1)
Plasmin
EXPERIMENTALeyes with macular edema
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hallym University Medical Centerlead
- Hallym Universitycollaborator
Study Sites (1)
Ji Won Lim
Chuncheon, Gangwon-do, 200-704, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiwon Lim, MDPhD
Chuncheon Sacred Heart Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
November 17, 2011
First Posted
November 23, 2011
Study Start
November 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2013
Last Updated
December 2, 2011
Record last verified: 2011-12