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

Diabetic Macular Edema Clinical Trial

— IBeTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310295
• Other study ID #: 12029-2008
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: December 5, 2014
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Device:
• Laser
focal macular laser therapy

Drug:
• Bevacizumab
Intravitreal injection of Bevacizumab
• Triamcinolone Acetonide
Intravitreal injection of Triamcinolone Acetonide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central subfield macular thickness	retinal thickness measured with optical coherence tomography	12 months	No
Primary	Visual acuity	Best corrected visual acuity	12 months	No