Evaluate 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
Multicenter, randomized clinical trial.
A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen
equivalent) of 20/32 to 20/320 and DME involving the fovea.
Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab
+ prompt laser (n=187), 0.5 mg ranibizumab + deferred (> or =24 weeks) laser (n=188),
or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated
by a web-based, real-time data-entry system.
Best-corrected visual acuity and safety at 1 year.
The 1-year mean change (+/-standard deviation) in the visual acuity letter score from
baseline was significantly greater in the ranibizumab + prompt laser group (+9+/-11,
P<0.001) and ranibizumab + deferred laser group (+9+/-12, P<0.001) but not in the
triamcinolone + prompt laser group (+4+/-13, P=0.31) compared with the sham + prompt
laser group (+3+/-13). Reduction in mean central subfield thickness in the triamcinolone
+ prompt laser group was similar to both ranibizumab groups and greater than in the
sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273),
visual acuity improvement in the triamcinolone + prompt laser group appeared comparable
to that in the ranibizumab groups. No systemic events attributable to study treatment
were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab
groups, whereas elevated intraocular pressure and cataract surgery were more frequent
in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar
to 1-year outcomes.
Intravitreal ranibizumab with prompt or deferred laser is more effective through at
least 1 year compared with prompt laser alone for the treatment of DME involving the
central macula. Ranibizumab as applied in this study, although uncommonly associated
with endophthalmitis, should be considered for patients with DME and characteristics
similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone
+ prompt laser seems more effective than laser alone but frequently increases the
risk of intraocular pressure elevation.
Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights