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

This study has been terminated.
(occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group)
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01141881
First received: June 10, 2010
Last updated: October 7, 2010
Last verified: September 2008
History of Changes
  Purpose

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


Condition Intervention
Diabetic Macular Edema
 Drug: Tissue Plasminogen Activator,bevacizumab ,follow up

Study Type: Interventional
Study Design: Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Mashhad University of Medical Sciences:

Study Start Date: May 2009
Study Completion Date: March 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: bevacizumab :avastin

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141881

Locations
Iran, Islamic Republic of
Khatam Hospital
Mashhad, Khorasan Razavi, Iran, Islamic Republic of
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Study Director: naser shoeibi, MD mashhad university of medical science
  More Information

Publications:

Responsible Party: naser shoeibi, Professor assistant of ophthalmology
ClinicalTrials.gov Identifier: NCT01141881     History of Changes
Other Study ID Numbers: 2202
Study First Received: June 10, 2010
Last Updated: October 7, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
Tissue Plasminogen activator,
Clinically significant macular edema,
Refractory Diabetic macular edema ,
posterior vitreous detachment

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Plasminogen
Tissue Plasminogen Activator
Bevacizumab
Fibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013