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

NCT ID: NCT01141881

Last Updated: 2010-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-03-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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TPA,IVB,F/U

Group Type EXPERIMENTAL

Tissue Plasminogen Activator,bevacizumab ,follow up

Intervention Type DRUG

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

Interventions

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Tissue Plasminogen Activator,bevacizumab ,follow up

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

Intervention Type DRUG

Other Intervention Names

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bevacizumab :avastin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Professor assistant of ophthalmology

Principal Investigators

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naser shoeibi, MD

Role: STUDY_DIRECTOR

mashhad university of medical science

Locations

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Khatam Hospital

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 18040240 (View on PubMed)

Other Identifiers

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2202

Identifier Type: -

Identifier Source: org_study_id