This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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)
Information provided by:
Mashhad University of Medical Sciences Identifier:
First received: June 10, 2010
Last updated: October 7, 2010
Last verified: September 2008
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:

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01141881

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

Responsible Party: naser shoeibi, Professor assistant of ophthalmology Identifier: NCT01141881     History of Changes
Other Study ID Numbers: 2202
Study First Received: June 10, 2010
Last Updated: October 7, 2010

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:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Tissue Plasminogen Activator
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017