Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema

Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.


Objective: To report 3-year outcomes of patients who participated in a randomized trial evaluating 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone compared with focal/grid photocoagulation for treatment of diabetic macular edema.

Methods: Eyes with diabetic macular edema and visual acuities of 20/40 to 20/320 were randomly assigned to focal/grid photocoagulation or 1 mg or 4 mg of triamcinolone. At the conclusion of the trial, 3-year follow-up data were available in 306 eyes.

Results: Between 2 years (time of the primary outcome) and 3 years, more eyes improved than worsened in all 3 treatment groups. Change in visual acuity letter score from baseline to 3 years was +5 in the laser group and 0 in each triamcinolone group. The cumulative probability of cataract surgery by 3 years was 31%, 46%, and 83% in the laser and 1-mg and 4-mg triamcinolone groups, respectively. Intraocular pressure increased by more than 10 mm Hg at any visit in 4%, 18%, and 33% of eyes, respectively.

Conclusions: Results in a subset of randomized subjects who completed the 3-year follow-up are consistent with previously published 2-year results and do not indicate a long-term benefit of intravitreal triamcinolone relative to focal/grid photocoagulation in patients with diabetic macular edema similar to those studied in this clinical trial. Most eyes receiving 4 mg of triamcinolone as given in this study are likely to require cataract surgery.

Trial registration: Identifier: NCT00367133.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Cataract / chemically induced
  • Cataract Extraction / statistics & numerical data
  • Diabetic Retinopathy / drug therapy
  • Diabetic Retinopathy / surgery
  • Diabetic Retinopathy / therapy*
  • Female
  • Follow-Up Studies
  • Glucocorticoids / adverse effects
  • Glucocorticoids / therapeutic use*
  • Humans
  • Injections
  • Intraocular Pressure
  • Laser Coagulation / methods*
  • Macular Edema / drug therapy
  • Macular Edema / surgery
  • Macular Edema / therapy*
  • Male
  • Middle Aged
  • Preservatives, Pharmaceutical
  • Retina / drug effects
  • Retina / pathology
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Triamcinolone Acetonide / adverse effects
  • Triamcinolone Acetonide / therapeutic use*
  • Visual Acuity
  • Vitreous Body


  • Glucocorticoids
  • Preservatives, Pharmaceutical
  • Triamcinolone Acetonide

Associated data