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

• Sponsor: Mashhad University of Medical Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01141881
• Collaborator: (none)
• Location: 1
• Arm: 1
• Duration (Months): 10

Study Details

Study Description

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	Phase
Diabetic Macular Edema	Drug: Tissue Plasminogen Activator,bevacizumab ,follow up	N/A

Study Design

• Study Type: Interventional
• 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 1, 2009
• Anticipated Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT01141881
• Other Study ID Numbers: 2202
• First Posted: Jun 11, 2010
• Last Update Posted: Oct 8, 2010
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Tissue Plasminogen activator,; Clinically significant macular edema,; Refractory Diabetic macular edema ,; posterior vitreous detachment
• Additional relevant MeSH terms: Macular Edema; Edema; Bevacizumab; Plasminogen; Tissue Plasminogen Activator

Study Results

No Results Posted as of Oct 8, 2010