Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema

摘要: Objective Evaluate intravitreal 0.5 mg ranibizumab or 4 triamcinolone combined with focal/grid laser compared alone for treatment of diabetic macular edema (DME). Design Multicenter, randomized clinical trial. Participants A total 854 study eyes 691 participants visual acuity (approximate Snellen equivalent) 20/32 to 20/320 and DME involving the fovea. Methods Eyes were sham injection + prompt (n=293), (n=187), deferred (≥24 weeks) (n=188), (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system. Main Outcome Measures Best-corrected safety at 1 year. Results The 1-year mean change (±standard deviation) in letter score from baseline was significantly greater group (+9±11, P =0.31) (+3±13). Reduction central subfield thickness similar both groups than group. In subset pseudophakic (n=273), improvement appeared comparable that groups. No systemic events attributable apparent. Three (0.8%) had injection-related endophthalmitis groups, whereas elevated intraocular pressure cataract surgery more frequent Two-year outcomes outcomes. Conclusions Intravitreal is effective through least year macula. Ranibizumab as applied this study, although uncommonly associated endophthalmitis, should be considered patients characteristics those eyes, seems but frequently increases risk elevation. Financial Disclosure(s) Proprietary commercial disclosure may found after references.