UMIN000021630.

Trial name or title	Anti‐VEGF and steroid combination therapy for diabetic macular oedema
Methods	Study design: parallel non‐masked prospective randomised controlled trial Unit of randomisation: not specified
Participants	Country: Japan Underlying conditions: diabetic macular oedema Inclusion criteria: > 20 years of age, clinically significant DMO refractory to laser treatment, Japanese LogMAR visual acuity 1.52‐1.22, CMT > 300 µm Exclusion criteria: treated with macular laser within 3 months, ischaemic maculopathy, vitreomacular traction, proliferative diabetic retinopathy, glaucoma, optic neuropathy, vitrectomy, phakic eye, previous intravitreal or subtenon steroid injection, steroid responder, heart failure, cerebral vascular disease,hematological disease, tumour, concurrent systemic steroids, renal failure (> CKD S3), grade III hypertension, HbA1c NGSP over 10%.
Interventions	Intervention 1: 2 months after loading doses of intravitreal ranibizumab injections, intravitreal ranibizumab is continued Intervention 2: 2 months after loading doses of intravitreal ranibizumab injections, an intravitreal triamcinolone injection is delivered The exact treatment schedule and retreatment criteria are not specified. Length of follow‐up: not specified
Outcomes	The primary outcome is the number of ranibizumab injections required over duration of trial. The length of the trial is not specified.
Starting date	27 March 2016
Contact information	upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000024947
Notes	Trial registration: UMIN000021630 Source of funding: Self funded

CKD: chronic kidney disease; DMO: diabetic macular oedema; ETDRS: Early Treatment Diabetic Retinopathy Study;Hb1Ac: glycated haemoglobin; LogMAR: Logarithm of the Minimum Angle of Resolution; NGSP: National Glycohemoglobin Standardization Program; OCT: optical coherence tomography;VEGF: vascular endothelial growth factor.