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OpenTrials
Completed

NCT Number: NCT02310295

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

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.

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

laser

Device

focal macular laser therapy

Bevacizumab

Drug

Intravitreal injection of Bevacizumab

Triamcinolone Acetonide

Drug

Intravitreal injection of Triamcinolone Acetonide

Primary outcomes

  1. Central subfield macular thickness

    Time frame: 12 months

    retinal thickness measured with optical coherence tomography

  2. Visual acuity

    Time frame: 12 months

    Best corrected visual acuity

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: IBeTA

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 8, 2014
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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