To report expanded 2-year follow-up of a previously reported randomized trial evaluating
intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser
compared with focal/grid laser alone for treatment of diabetic macular edema (DME).
Multicenter, randomized clinical trial.
A total of 854 study eyes of 691 participants with visual acuity of 20/32 to 20/320
(approximate Snellen equivalent) and DME involving the fovea.
Continuation of procedures previously reported for the randomized trial.
Best-corrected visual acuity and safety at the 2-year visit.
At the 2-year visit, compared with the sham + prompt laser group, the mean change
in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab
+ prompt laser group (95% confidence interval adjusted for multiple comparisons [aCI],
-0.4 to +7.7), 5.8 letters greater in the ranibizumab + deferred laser group (95%
aCI, +1.9 to +9.8), and 1.5 letters worse in the triamcinolone + prompt laser group
(95% aCI, -5.5 to +2.4). After the 1- to 2-year visit in the ranibizumab + prompt
or deferred laser groups, the median numbers of injections were 2 and 3 (potential
maximum of 13), respectively. At the 2-year visit, the percentages of eyes with central
subfield thickness ≥250 μm were 59% in the sham + prompt laser group, 43% in the ranibizumab
+ prompt laser group, 42% in the ranibizumab + deferred laser group, and 52% in the
triamcinolone + prompt laser group. No systemic events attributable to study treatment
were apparent. Three eyes in 3 (0.8%) of 375 participants had injection-related endophthalmitis
in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery
were more frequent in the triamcinolone + prompt laser group.
The expanded 2-year results reported are similar to results published previously and
reinforce the conclusions originally reported: Ranibizumab should be considered for
patients with DME and characteristics similar to those of the cohort in this clinical
trial, including vision impairment with DME involving the center of the macula.
Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All
rights reserved.