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


BACKGROUND
clinicaltrials.gov Identifier: NCT00367133.
Beck
Roy W
RW
Edwards
Allison R
AR
Aiello
Lloyd P
LP
Bressler
Neil M
NM
Ferris
Frederick
F
Glassman
Adam R
AR
Hartnett
Elizabeth
E
Ip
Michael S
MS
Kim
Judy E
JE
Kollman
Craig
C
D000368:Aged; D002386:Cataract / Q000139:chemically induced; D002387:Cataract Extraction / Q000706:statistics & numerical data; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007267:Injections; D007429:Intraocular Pressure; D017075:Laser Coagulation / Q000379:methods*; D008269:Macular Edema / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011310:Preservatives, Pharmaceutical; D012160:Retina / Q000187:drug effects / Q000473:pathology; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000009:adverse effects / Q000627:therapeutic use*; D014792:Visual Acuity; D014822:Vitreous Body
D005938:Glucocorticoids; D011310:Preservatives, Pharmaceutical; D014222:Triamcinolone Acetonide