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Susan B Bressler, Diabetic Retinopathy Clinical Research Network; Five Year Outcomes in Eyes with Diabetic Macula Edema Randomly Assigned to Ranibizumab with Prompt or Deferred Laser or Laser with or without Triamcinolone with very Deferred Ranibizumab. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3147.
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To evaluate the five-year visual acuity and OCT thickness outcomes in eyes with center involved diabetic macular edema (DME) treated with intravitreous ranibizumab (with prompt or deferred laser) as compared with prompt laser or intravitreous triamcinolone with prompt laser with ranibizumab permitted in the latter two groups approximately two years after randomization
828 study eyes of 673 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea were enrolled at 52 clinical centers. Eyes were assigned randomly to sham injection+laser, 0.5 mg ranibizumab+prompt laser, 0.5 mg ranibizumab+deferred laser, or 4 mg triamcinolone+prompt laser until a change in protocol (beyond 78 weeks) allowed ranibizumab approximately two years after randomization (“very deferred ranibizumab”) in the sham+laser and the triamcinolone+laser groups. Main outcome measures are best corrected visual acuity (BCVA), central subfield (CSF) thickness on OCT, and safety at 5 years.
BCVA and CSF OCT outcomes seen at the 1-year visit in the ranibizumab groups were sustained, on average, through 5 years. At 5 years, mean (±SD) improvement in VA letter score from baseline in the ranibizumab+prompt laser and the ranibizumab+deferred laser groups were 8±13 and 10±13, respectively. Between 78 weeks and 5 years, approximately 60% of the eyes in each of the laser and triamcinolone+laser group received at least one ranibizumab injection. At five years the mean (±SD) change in VA letter score from baseline in laser+ very deferred ranibizumab and triamcinolone + laser+ very deferred ranibizumab groups were 5±14 and 7±14 respectively. The subset of laser and laser+triamcinolone eyes with 6-month follow-up after receipt of ranibizumab will be presented to explore short-term effects of the ranibizumab deferred for this amount of time.
Initial management of center-involving DME with prompt laser or triamcinolone+laser followed by very deferred ranibizumab, if thickening persists, does not appear to achieve the same long-term vision improvements as those associated with ranibizumab therapy with either prompt or deferred laser at 5 years.
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