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

Diabetic Macular Edema Clinical Trial

Official title:

Evaluation of the Role of Intravitreal Injection of TPA in Treatment of Refractory Diabetic Macular Edema

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01141881
• Other study ID #: 2202
• Status: Terminated
• Phase: N/A
• First received: June 10, 2010
• Last updated: October 7, 2010
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: September 2008
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Tissue Plasminogen Activator,bevacizumab ,follow up
25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing

Locations

Country	Name	City	State
Iran, Islamic Republic of	Khatam Hospital	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & 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. — View Citation