Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Terminated
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Tissue Plasminogen Activator,bevacizumab ,follow up
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Tissue Plasminogen activator,, Clinically significant macular edema,, Refractory Diabetic macular edema ,, posterior vitreous detachment
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes
- Non proliferative diabetic retinopathy(NPDR) stage of diabetic retinopathy
- patients with refractory DME CSME (patients with the last MPC at least 3 months before and no improvement was observed in BCVA, macular thickness inOCT, clinical examination and fundus photographs of patients )
- Absence of PVD in the B-scan
- Absence of PVD in OCT of macular area and optic disk
- Absence of PVD in slit lamp biomicroscopy(SLE)
- the last PRP session was at least 3 months ago.
- Absence of traction on macula in clinical examination and OCT
Exclusion Criteria:
- One eye patients
- Patients who are candidates for intraocular surgery.
- Patients with the history of glaucoma or ocular hypertension
- Patients with a history of vitrectomy in the study eye
- Not being able to refer for the next visits
- Eyes with cataract that makes the assessment of the macula impossible.
- Intraretinal hemorrhage at fovea that will interfere with OCT.
- BCVA ≤ 0.1
Sites / Locations
- Khatam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TPA,IVB,F/U
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01141881
First Posted
June 10, 2010
Last Updated
October 7, 2010
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01141881
Brief Title
Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema
Official Title
Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Tissue Plasminogen activator,, Clinically significant macular edema,, Refractory Diabetic macular edema ,, posterior vitreous detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Investigator
8. Arms, Groups, and Interventions
Arm Title
TPA,IVB,F/U
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tissue Plasminogen Activator,bevacizumab ,follow up
Other Intervention Name(s)
bevacizumab :avastin
Intervention Description
25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes
Non proliferative diabetic retinopathy(NPDR) stage of diabetic retinopathy
patients with refractory DME CSME (patients with the last MPC at least 3 months before and no improvement was observed in BCVA, macular thickness inOCT, clinical examination and fundus photographs of patients )
Absence of PVD in the B-scan
Absence of PVD in OCT of macular area and optic disk
Absence of PVD in slit lamp biomicroscopy(SLE)
the last PRP session was at least 3 months ago.
Absence of traction on macula in clinical examination and OCT
Exclusion Criteria:
One eye patients
Patients who are candidates for intraocular surgery.
Patients with the history of glaucoma or ocular hypertension
Patients with a history of vitrectomy in the study eye
Not being able to refer for the next visits
Eyes with cataract that makes the assessment of the macula impossible.
Intraretinal hemorrhage at fovea that will interfere with OCT.
BCVA ≤ 0.1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
naser shoeibi, MD
Organizational Affiliation
mashhad university of medical science
Official's Role
Study Director
Facility Information:
Facility Name
Khatam Hospital
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18040240
Citation
Murakami T, Takagi H, Ohashi H, Kita M, Nishiwaki H, Miyamoto K, Watanabe D, Sakamoto A, Yamaike N, Yoshimura N. Role of posterior vitreous detachment induced by intravitreal tissue plasminogen activator in macular edema with central retinal vein occlusion. Retina. 2007 Oct;27(8):1031-7. doi: 10.1097/IAE.0b013e318074bc39.
Results Reference
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Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema
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