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

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Device: Laser; Drug: Triamcinolone Acetonide; Drug: Bevacizumab

• Registration Number: NCT02310295
• Lead Sponsor: University of Sao Paulo

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2014-12
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-05
• Last Update Submitted: 2014-12-05
• Study First Posted: 2014-12-08
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVB-Laser	Laser	Intravitreal Bevacizumab combined with focal laser therapy
Laser	Laser	focal laser therapy
IVTA-Laser	Laser	Intravitreal Triamcinolone combined with focal laser therapy
IVTA-Laser	Triamcinolone Acetonide	Intravitreal Triamcinolone combined with focal laser therapy
IVB-Laser	Bevacizumab	Intravitreal Bevacizumab combined with focal laser therapy

Primary Outcome Measures

Name	Time	Method
Central subfield macular thickness	12 months	retinal thickness measured with optical coherence tomography
Visual acuity	12 months	Best corrected visual acuity