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Purpose  To assess efficacy and safety of intravitreal ranibizumab 0.5 mg plus laser ( COMBI ) versus laser monotherapy ( LASER ) in patients with visual impairment due to diabetic macular oedema ( DME ) in either nonproliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy ( PDR ) and to analyse the relevance of inner versus outer retinal thickness.    Methods  In this double‐masked, multicentre phase  III b study, patients ( N  = 128) were randomized (2:1) to receive  COMBI  ( n  = 85) versus  LASER  ( n  = 43). Patients received four initial monthly injections of ranibizumab 0.5 mg ( COMBI ) or sham ( LASER ) followed by pro re nata (PRN) injections. In both groups, patients received laser at baseline and additional laser at 3 monthly intervals, as needed. The study was started in 2010 and was prematurely terminated due to approval of ranibizumab for  DME .    Results  The least squares ( LS ) mean change in mean best‐corrected visual acuity ( BCVA ) from baseline to month 12 was higher in the  COMBI  (6.5) versus  LASER  (2.3) group ( LS  mean difference: 4.2 [95%  CI  0.9; 7.4] letters, p = 0.01, primary end‐point). There was also a tendency in the same direction for the subgroup of 26 patients with  PDR  ( LS  mean difference 14.7, p = 0.11). Mean central retinal thickness decreased by 107.3  μ m in the  COMBI  group and by 80.3  μ m in the  LASER  group from baseline to month 12 (p = 0.28). Ranibizumab was well tolerated.    Conclusion  This study showed that ranibizumab plus laser is a valuable treatment option for the management of  DME . Patients with  DME  in  PDR  might also benefit from combined therapy compared to laser alone.

acta ophthalmologica

The  RELATION  study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in  NPDR  and  PDR  patients with diabetic macular oedema