A randomized clinical trial comparing fixed vs pro-re-nata dosing of Ozurdex in refractory diabetic macular oedema (OZDRY study).

ABSTRACT:

Objective

To compare the clinical effectiveness and safety of 5-monthly fixed dosing vs pro-re-nata (PRN) Ozurdex treatment in patients with refractory diabetic macular oedema (DMO).

Design

Prospective, multicentre, randomized active-controlled non-inferiority clinical trial.

Participants

Participants were 100 patients who attended Medical Retina Clinics for management of centre-involving refractory DMO.

Interventions

Participants were randomized 1 : 1 to either 5-monthly fixed dosing or optical coherence tomography (OCT)-guided PRN regimen of Ozurdex therapy for DMO. Data were collected on best-corrected visual acuity (BCVA), patient-reported outcome measures (PROM), macular thickness and morphology, diabetic retinopathy status, number of injections and advers

SUBMITTER: Ramu J 

PROVIDER: S-EPMC5129797 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature