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

Abstract

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:

clinicaltrials.gov Identifier: NCT00367133.

• Authors: Diabetic Retinopathy Clinical Research Network (DRCR.net), Roy W Beck, Allison R Edwards, Lloyd P Aiello, Neil M Bressler, Frederick Ferris, Adam R Glassman, Elizabeth Hartnett, Michael S Ip, Judy E Kim, Craig Kollman
• Journal: Archives of ophthalmology (Chicago, Ill. : 1960) (Arch Ophthalmol) Vol. 127 Issue 3 Pg. 245-51 (Mar 2009) ISSN: 1538-3601 [Electronic] United States
• PMID: 19273785 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Glucocorticoids
• Preservatives, Pharmaceutical
• Triamcinolone Acetonide

Topics

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