Premium
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
Author(s) -
Lang Gabriele E.,
Liakopoulos Sandra,
Vögeler Jessica,
Weiß Claudia,
Spital Georg,
Gamulescu MariaAndreea,
Lohmann Chris,
Wiedemann Peter
Publication year - 2018
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/aos.13574
Subject(s) - medicine , ranibizumab , diabetic retinopathy , pro re nata , ophthalmology , visual acuity , laser coagulation , clinical endpoint , laser , laser treatment , retinal , surgery , diabetes mellitus , randomized controlled trial , bevacizumab , endocrinology , chemotherapy , physics , optics
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.