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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
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. type 2 diabetes
  2. Non proliferative diabetic retinopathy(NPDR) stage of diabetic retinopathy
  3. 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 )
  4. Absence of PVD in the B-scan
  5. Absence of PVD in OCT of macular area and optic disk
  6. Absence of PVD in slit lamp biomicroscopy(SLE)
  7. the last PRP session was at least 3 months ago.
  8. Absence of traction on macula in clinical examination and OCT

Exclusion Criteria:

  1. One eye patients
  2. Patients who are candidates for intraocular surgery.
  3. Patients with the history of glaucoma or ocular hypertension
  4. Patients with a history of vitrectomy in the study eye
  5. Not being able to refer for the next visits
  6. Eyes with cataract that makes the assessment of the macula impossible.
  7. Intraretinal hemorrhage at fovea that will interfere with OCT.
  8. 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

First Posted
June 10, 2010
Last Updated
October 7, 2010
Sponsor
Mashhad University of Medical Sciences
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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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