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

Acta Ophthalmologica
Gabriele E LangPeter Wiedemann

Abstract

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. In this double-masked, multicentre phase IIIb 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. 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 ...Continue Reading

References

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Apr 30, 2010·Ophthalmology·UNKNOWN Diabetic Retinopathy Clinical Research NetworkJennifer K Sun
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Sep 12, 2012·Archives of Ophthalmology·Susan B BresslerUNKNOWN Diabetic Retinopathy Clinical Research Network
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Nov 14, 2015·JAMA : the Journal of the American Medical Association·UNKNOWN Writing Committee for the Diabetic Retinopathy Clinical Research NetworkRoy W Beck

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Citations

Mar 11, 2021·Journal of Ophthalmology·Claudio FurinoGiovanni Alessio

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Methods Mentioned

BETA
FCS

Clinical Trials Mentioned

NCT01131585

Software Mentioned

net
DRCR

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