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Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema

Intervention: Laser (Device); Bevacizumab (Drug); Triamcinolone Acetonide (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Sao Paulo

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 Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.

Clinical Details

Official title: Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Central subfield macular thickness

Visual acuity

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination 2. BCVA between 0. 3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1. 6 LogMAR (20/800) 3. signed of inform Consent. Exclusion Criteria: 1. HbA1c levels greater than 10% 2. thromboembolic event history (including myocardial infarction and stroke) 3. vitreo-macular traction on OCT 4. coagulation disorders 5. macular ischemia on fluorescein angiography examination 6. proliferative diabetic retinopathy that required treatment 7. eye surgery 8. history of ocular hypertension or glaucoma 9. 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) 10. systemic corticosteroid therapy 11. any conditions that could affect the documentation 12. any previous treatment for diabetic macular edema.

Locations and Contacts

Additional Information

Starting date: January 2009
Last updated: December 5, 2014

Page last updated: August 23, 2015

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