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

Not Applicable

Terminated

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Tissue Plasminogen Activator,bevacizumab ,follow up

• Registration Number: NCT01141881
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-09
• Study Start: 2009-05
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Last Update Submitted: 2010-10-07
• Last Update Posted: 2010-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TPA,IVB,F/U	Tissue Plasminogen Activator,bevacizumab ,follow up	-

Trial Locations

Locations (1)

Khatam Hospital; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of