Status:
COMPLETED
Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema
Lead Sponsor:
University of Sao Paulo
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Meth...
Eligibility Criteria
Inclusion
- clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
- BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
- signed of inform Consent.
Exclusion
- HbA1c levels greater than 10%
- thromboembolic event history (including myocardial infarction and stroke)
- vitreo-macular traction on OCT
- coagulation disorders
- macular ischemia on fluorescein angiography examination
- proliferative diabetic retinopathy that required treatment
- eye surgery
- history of ocular hypertension or glaucoma
- any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
- systemic corticosteroid therapy
- any conditions that could affect the documentation
- any previous treatment for diabetic macular edema.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02310295
Start Date
January 1 2009
End Date
December 1 2012
Last Update
December 8 2014
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