Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema

October 7, 2010 updated by: Mashhad University of Medical Sciences

Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema

Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TPA,IVB,F/U
Drug: Tissue Plasminogen Activator,bevacizumab ,follow up
25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing
Other Names:
  • bevacizumab :avastin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Study Director: naser shoeibi, MD, Mashhad University of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2010

Last Update Submitted That Met QC Criteria

October 7, 2010

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

3
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