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

NCT01141881 | Terminated DMC

• 1 other identifier: 2202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Tissue Plasminogen activator,; Clinically significant macular edema,; Refractory Diabetic macular edema ,; posterior vitreous detachment

Study Arms (1)

TPA,IVB,F/U

EXPERIMENTAL

Drug: Tissue Plasminogen Activator,bevacizumab ,follow up

Interventions

Tissue Plasminogen Activator,bevacizumab ,follow up DRUG

25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing

Also known as: bevacizumab :avastin

TPA,IVB,F/U

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Khatam Hospital

Mashhad, Khorasan Razavi, Iran

Location

Related Publications (1)

• 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.

  PMID: 18040240 BACKGROUND

MeSH Terms

Conditions

Vitreous Detachment

Interventions

Tissue Plasminogen Activator; Bevacizumab

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Serum Globulins; Globulins

Study Officials

• naser shoeibi, MD

  mashhad university of medical science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: May 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 8, 2010

Record last verified: 2008-09

Locations

IR (1)