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Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

Primary Purpose

Macular Edema

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravitreal injection
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring autologous plasmin, macular edema, vitreous

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ji Won LimRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Plasmin

Arm Description

eyes with macular edema

Outcomes

Primary Outcome Measures

Central macular thickness after intravitreal autologous plasmin injection
Central macular thickness measured by optocal coherence tompgraphy
Visual acuity after intravitreal autologous plasmin
logMAR visual acuity

Secondary Outcome Measures

fibrinolytic system
plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin

Full Information

First Posted
November 17, 2011
Last Updated
December 1, 2011
Sponsor
Hallym University Medical Center
Collaborators
Hallym University
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1. Study Identification

Unique Protocol Identification Number
NCT01478516
Brief Title
Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy
Official Title
Autologous Intravitreal Plasmin and Fibrinolytic System of Vitreous in Patient With Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Medical Center
Collaborators
Hallym University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
Keywords
autologous plasmin, macular edema, vitreous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plasmin
Arm Type
Experimental
Arm Description
eyes with macular edema
Intervention Type
Procedure
Intervention Name(s)
Intravitreal injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Central macular thickness after intravitreal autologous plasmin injection
Description
Central macular thickness measured by optocal coherence tompgraphy
Time Frame
1 month after intervention
Title
Visual acuity after intravitreal autologous plasmin
Description
logMAR visual acuity
Time Frame
1 Month after intervention
Secondary Outcome Measure Information:
Title
fibrinolytic system
Description
plasminogen, tissue plasminogen activetor, anti-pasminogen receptor, antithrombin
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JiWOn Lim, MDPhD
Phone
82-33-240-5176
Email
jiwoneye@hallym.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiwon Lim, MDPhD
Organizational Affiliation
Chuncheon Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ji Won Lim
City
Chuncheon
State/Province
Kangwon-do
ZIP/Postal Code
200-704
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jj Won Lim, MD PhD
Phone
82-33-240-5176
Email
jiwoneye@hallym.or.kr

12. IPD Sharing Statement

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Autologous Plasmin and Fibrinolytic System in Diabetic Retinopathy

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