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Randomized Controlled Trial
. 2015 Dec;29(12):1603-12.
doi: 10.1038/eye.2015.214. Epub 2015 Oct 23.

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

J Ramu  1 , Y Yang  2 , G Menon  3 , C Bailey  4 , N Narendran  2 , C Bunce  1 , A Quartilho  1 , A T Prevost  5 , P Hykin  1 , S Sivaprasad  1 ; OZDRY Study Group
Affiliations
Randomized Controlled Trial

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

J Ramu et al. Eye (Lond). 2015 Dec.

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 adverse events from baseline for a period of 12 months.Main outcome measuresThe primary outcome was the difference between arms in change in BCVA from baseline to 12 months. The prespecified non-inferiority margin was five ETDRS letters. Key secondary outcomes included change in PROM scores, change in macular thickness, change in retinopathy and macular morphology, and safety profile.

Results: The mean change in BCVA was +1.48 (SD 14.8) in the fixed arm vs -0.17 (SD 13.1) in the PRN arm, with adjusted effect estimate +0.97, 90% confidence interval (-4.01, +5.95), P=0.02 (per protocol analysis). The conclusions of the ITT analysis were primarily supportive, -0.34 (-5.49, 4.81) P=0.07, but sensitive to an alternative assumption on missing data, +0.28 (-4.72, 5.27) P=0.04.

Conclusions: The mean change in BCVA with 5-monthly fixed dosing of Ozurdex was non-inferior to OCT-guided PRN Ozurdex therapy for refractory DMO based on a per protocol analysis.

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Conflict of interest statement

YY: consultant—Bayer Healthcare, Alimera Sciences; personal fees—Alcon Inc., Pfizer Inc., Novartis Pharmaceutical, Inc., Allergan Inc., Bayer Healthcare; lecture fees—Bayer Healthcare, Novartis Pharmacueticals, Plc; grant outside the submitted work: Bayer Healthcare, Novartis Pharmaceutical, Inc., Roche Inc.; NN: consultant—Novartis Pharmacuetical, Inc. GM: consultant—Bayer Healthcare, Alcon Inc., Novartis Pharmaceutical, Inc., Allergan Inc.; grant outside the submitted work—Bayer Healthcare; Novartis Pharmaceutical, Inc., Allergan Inc., Alcon Plc, Roche Inc. CB: consultant—Bayer Healthcare, Alimera Sciences, Alcon Inc., Novartis Pharmaceutical, Inc., Allergan Inc.; lecture fees—Bayer Healthcare, Novartis Pharmacueticals, Plc; grant outside the submitted work—Bayer Healthcare; Novartis Pharmaceutical, Inc., Allergan Inc., Alcon Plc, Roche Inc. PH: consultant—Bayer Healthcare, Novartis Pharmaceutical, Inc., Allergan Inc.; lecture fees—Bayer Healthcare, Novartis Pharmacueticals, Plc; grant outside the submitted work—Bayer Healthcare; Novartis Pharmaceutical, Inc., Allergan Inc. SS: consultant—Bayer Healthcare, Novartis Pharmaceutical, Inc., Allergan Inc., Roche Inc.; lecturer—Bayer Healthcare, Novartis Pharmacueticals, Plc, Allergan Plc; grant outside the submitted work—Bayer Healthcare; Novartis Pharmaceutical, Inc., Allergan Inc., Roche Inc. The other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
CONSORT flow diagram.
Figure 2
Figure 2
Primary analysis treatment effect estimates with respective to two-sided 90% confidence interval—fixed vs PRN dosing.
See this image and copyright information in PMC

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