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

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ClinicalTrials.gov Identifier: NCT01141881
Recruitment Status : Terminated (occurrence of retinal hemorrhage , increase in macular edema of some patients in TPA group)
First Posted : June 11, 2010
Last Update Posted : October 8, 2010
Sponsor:
Information provided by:
Mashhad University of Medical Sciences

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

Condition or disease Intervention/treatment
Diabetic Macular Edema Drug: Tissue Plasminogen Activator,bevacizumab ,follow up

Study Type : Interventional  (Clinical Trial)
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema
Study Start Date : May 2009
Estimated Primary Completion Date : January 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

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 Name: bevacizumab :avastin




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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: naser shoeibi, Professor assistant of ophthalmology
ClinicalTrials.gov Identifier: NCT01141881     History of Changes
Other Study ID Numbers: 2202
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: October 8, 2010
Last Verified: September 2008

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
Bevacizumab
Plasminogen
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