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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02310295

Acronym

IBeTA

Enrollment

Registered

2014-12-08

Start date

2009-01-31

Completion date

2012-12-31

Last updated

2014-12-08

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

Conditions

Diabetic Macular Edema

Keywords

Diabetic retinopathy, Macular edema, Anti-VEGF, Triamcinolone

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.

Interventions

DEVICELaser

focal macular laser therapy

DRUGBevacizumab

Intravitreal injection of Bevacizumab

DRUGTriamcinolone Acetonide

Intravitreal injection of Triamcinolone Acetonide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Central subfield macular thickness	12 months	retinal thickness measured with optical coherence tomography
Visual acuity	12 months	Best corrected visual acuity

Outcome results

None listed

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