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CompletedNCT02310295IBeTAUpdated Dec 8, 2014

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

An interventional study of Laser and Bevacizumab in Diabetic Macular Edema, sponsored by University of Sao Paulo. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-08.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Macular Edema

Keywords

  • Diabetic retinopathy
  • Macular edema
  • Anti-VEGF
  • Triamcinolone
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    IVB-Laser

    Intravitreal Bevacizumab combined with focal laser therapy

    Device: Laser · Drug: Bevacizumab

  • Active comparator
    IVTA-Laser

    Intravitreal Triamcinolone combined with focal laser therapy

    Device: Laser · Drug: Triamcinolone Acetonide

  • Active comparator
    Laser

    focal laser therapy

    Device: Laser

Interventions

  • DeviceLaser

    focal macular laser therapy

  • DrugBevacizumab

    Intravitreal injection of Bevacizumab

  • DrugTriamcinolone Acetonide

    Intravitreal injection of Triamcinolone Acetonide

06

What researchers measure

Primary outcomes

  1. Central subfield macular thickness

    retinal thickness measured with optical coherence tomography

    Time frame: 12 months

  2. Visual acuity

    Best corrected visual acuity

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02310295
Lead sponsor
University of Sao Paulo
Responsible party
Andre Messias (PhD, University of Sao Paulo) — Principal investigator
First posted
Dec 8, 2014
Start date
Jan 2009
Primary completion
Dec 2011
Completion
Dec 2012
Last update
Dec 8, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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