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Brian B. Berger, Diabetic Retinopathy Clinical Research Network; Expanded Two-year Follow Up Of A Randomized Trial Evaluating Ranibizumab Plus Prompt Or Deferred Laser Or Triamcinolone Plus Prompt Laser For Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2011;52(14):5335.
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To report expanded 2-year follow-up of a 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).
854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea were enrolled in a multicenter, randomized clinical trial. The previously reported protocol was followed. Expanded 2-year data were available for 642 eyes among 526 participants.
At the 2-year visit, compared with the sham plus prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 (95% confidence interval adjusted for multiple comparisons [aCI]: -0.4 to +7.7) letters greater in the ranibizumab plus prompt laser group, 5.8 (95% aCI: +1.9 to +9.8) letters greater in the ranibizumab plus deferred laser group, and 1.5 (95% aCI : -5.5 to +2.4) letter less in the triamcinolone plus prompt laser group. During the 2nd year in the ranibizumab with prompt or deferred laser groups, the median numbers of injections were 2 and 3 (potential maximum of 13), respectively. At the 2-year visit, percentages of eyes with central subfield thickness ≥250µm 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. In psuedophakic eyes, results with intravitreal triamcinolone plus prompt laser appeared similar to results in the ranibizumab arms and were more effective than laser alone, but the triamcinolone plus prompt laser arm had an increased risk of intraocular pressure elevation.
Two-year expanded results reinforce conclusions originally reported; ranibizumab should be considered for patients with central DME with vision impairment and characteristics similar to the cohort in this clinical trial.
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