Five-Year Outcomes of Ranibizumab With Prompt or Deferred Laser Versus Laser or Triamcinolone Plus Deferred Ranibizumab for Diabetic Macular Edema

Abstract

Purpose: To compare long-term vision and anatomic effects of ranibizumab with prompt or deferred laser vs laser or triamcinolone + laser with very deferred ranibizumab in diabetic macular edema (DME).

Design: Randomized clinical trial.

Methods: Eight hundred and twenty-eight study eyes (558 [67%] completed the 5-year visit), at 52 sites, with visual acuity 20/32 to 20/320 and DME involving the central macula were randomly assigned to intravitreous ranibizumab (0.5 mg) with either (1) prompt or (2) deferred laser; (3) sham injection + prompt laser; or (4) intravitreous triamcinolone (4 mg) + prompt laser. The latter 2 groups could initiate ranibizumab as early as 74 weeks from baseline, for persistent DME with vision impairment. The main outcome measures were visual acuity, optical coherence central subfield thickness, and number of injections through 5 years.

Results: At 5 years mean (± standard deviation) change in Early Treatment Diabetic Retinopathy Study visual acuity letter scores from baseline in the ranibizumab + deferred laser (N = 111), ranibizumab + prompt laser (N = 124), laser/very deferred ranibizumab (N = 198), and triamcinolone + laser/very deferred ranibizumab (N = 125) groups were 10 ± 13, 8 ± 13, 5 ± 14, and 7 ± 14, respectively. The difference (95% confidence interval) in mean change between ranibizumab + deferred laser and laser/very deferred ranibizumab and triamcinolone + laser/very deferred ranibizumab was 4.4 (1.2-7.6, P = .001) and 2.8 (-0.9 to 6.5, P = .067), respectively, at 5 years.

Conclusions: Recognizing limitations of follow-up available at 5 years, eyes receiving initial ranibizumab therapy for center-involving DME likely have better long-term vision improvements than eyes managed with laser or triamcinolone + laser followed by very deferred ranibizumab for persistent thickening and vision impairment.

Figure 1

Mean change in visual acuity letter score over 5 years from a randomized trial comparing ranibizumab with prompt or deferred laser, laser with deferred ranibizumab, and triamcinolone plus deferred ranibizumab in eyes with vision impairment from center-involved diabetic macular edema.

Figure 2

Mean change in optical coherence tomography central subfield thickness over 5 years from a randomized trial comparing ranibizumab with prompt or deferred laser, laser with deferred ranibizumab, and triamcinolone plus deferred ranibizumab in eyes with vision impairment from center-involved diabetic macular edema.

Figure 3

Mean change in (Left) visual acuity and (Right) central subfield thickness over 5 years for pseudophakic eyes from a randomized trial comparing ranibizumab with prompt or deferred laser, laser with deferred ranibizumab, and triamcinolone plus deferred ranibizumab in eyes with vision impairment from center-involved diabetic macular edema.

Figure 4

Changes in visual acuity and central subfield thickness 24 weeks after initiation of very deferred ranibizumab in eyes with visual acuity impairment from diabetic macular edema randomly assigned to laser or triamcinolone plus laser. (Left) Mean change in visual acuity letter score. (Right) Mean change in central subfield thickness.