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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01141881
Enrollment
Unknown
Registered
2010-06-11
Start date
2009-05-31
Completion date
2010-03-31
Last updated
2010-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Tissue Plasminogen activator,, Clinically significant macular edema,, Refractory Diabetic macular edema ,, posterior vitreous detachment

Brief summary

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

Interventions

DRUGTissue Plasminogen Activator,bevacizumab ,follow up

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

Sponsors

Mashhad University of Medical Sciences
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026