title: A prospective randomised controlled clinical trial comparing a combination of repeated intravitreal Ozurdex and macular laser therapy versus macular laser only in centre-involving diabetic macular oedema (OZLASE study).
abstract: OBJECTIVE
  To evaluate the clinical efficacy and safety of combined repeated Ozurdex and macular laser therapy (MLT) compared with MLT monotherapy in participants with visual impairment due to centre-involving diabetic macular oedema (DMO).
  
  
  METHODS
  80 patients with best corrected visual acuity (BCVA) between 54 and 78 ETDRS letters due to centre-involving DMO were randomised to combination therapy with Ozurdex and MLT or MLT only. The combination arm received mandated Ozurdex injections at baseline and 16 weeks followed by retreatment criteria-guided pro-re-nata therapy at 32 and 48 weeks. Patients randomised to MLT only were treated every 16 weeks if clinically significant macular oedema was present. The primary outcome was the mean change from baseline in BCVA between arms at 56 weeks.
  
  
  RESULTS
  The mean change in BCVA at 56 weeks was -0.3 (SD 11.4) ETDRS letters in the combination arm versus +0.4 (SD 9.6) ETDRS (Early Treatment Diabetic Retinopathy study) letters in the MLT arm (effect estimate 1.15 (95% CI -3.32 to 5.61)). However, at 56 weeks, a post hoc comparison of central subfield thickness (CST) showed a decrease of -113 μm (IQR -218, -64) (combination) versus -17 μm (-128, 12) (MLT arm) (p<0.001). Elevated intraocular pressure requiring topical therapy was observed in 8 (20%) eyes in the combination versus 1 (2.5%) in the MLT arm. 33% (9/27) of phakic patients in the combination arm underwent cataract surgery.
  
  
  CONCLUSIONS
  Visual outcome following combination therapy did not differ from MLT alone in the centre-involving DMO despite a significant decrease in CST likely due to an entry visual acuity-related ceiling effect and cataract development.
  
  
  BACKGROUND
  EudraCT 2011-003339-74.
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Ling Zhi
authors.initials: LZ
authors.lastname: Heng
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Sobha
authors.initials: S
authors.lastname: Sivaprasad
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Roxanne
authors.initials: R
authors.lastname: Crosby-Nwaobi
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Zubin
authors.initials: Z
authors.lastname: Saihan
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Karampelas
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Catey
authors.identifier: http://orcid.org/0000-0002-0935-3713
authors.initials: C
authors.lastname: Bunce
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Tunde
authors.initials: T
authors.lastname: Peto
authors.affiliation: Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, NIHR Moorfields Biomedical Research Centre, London, UK.
authors.forename: Philip G
authors.initials: PG
authors.lastname: Hykin
mesh_terms: D000368:Aged; D003692:Delayed-Action Preparations; D003907:Dexamethasone / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000150:complications* / Q000628:therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D058449:Intravitreal Injections; D053685:Laser Therapy / Q000379:methods*; D008266:Macula Lutea / Q000000981:diagnostic imaging*; D008269:Macular Edema / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D003692:Delayed-Action Preparations; D005938:Glucocorticoids; D003907:Dexamethasone
keywords: Drugs; Macula; Retina; Treatment Medical