To compare ranibizumab with focal/grid laser or a combination of both in diabetic
macular edema (DME).
Prospective, randomized, interventional, multicenter clinical trial.
A total of 126 patients with DME.
Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months
1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline
and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab
and focal/grid laser at baseline and month 3 (group 3, 42 patients).
The primary end point was the change from baseline in best-corrected visual acuity
(BCVA) at month 6.
At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters,
P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3
(+3.80 letters) was not statistically different from groups 1 or 2. For patients with
data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%)
in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and
3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45%
in groups 1, 2, and 3, respectively.
During a span of 6 months, ranibizumab injections by the current protocol had a significantly
better visual outcome than focal/grid laser treatment in patients with DME.