Status:
TERMINATED
Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema
Lead Sponsor:
Mashhad University of Medical Sciences
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
Phase:
NA
Brief Summary
Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01141881
Start Date
May 1 2009
End Date
March 1 2010
Last Update
October 8 2010
Active Locations (1)
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1
Khatam Hospital
Mashhad, Khorasan Razavi, Iran