title: Topical dexamethasone γ-cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema.
abstract: OBJECTIVE
  To compare in a randomized, controlled trial topical 1.5% dexamethasone γ-cyclodextrin nanoparticle eye drops (DexNP) with posterior subtenon injection of triamcinolone acetonide in diabetic macular oedema (DME).
  
  
  METHODS
  In this prospective, randomized, controlled trial, 22 eyes of 22 consecutive patients with DME were randomized to (i) topical treatment with DexNP ×3/day (4 weeks), ×2/day (4 weeks) and ×1/day (4 weeks) or (ii) one posterior subtenon injection of 20 mg triamcinolone acetonide. Study visits were at baseline and 4, 8, 12 and 16 weeks.
  
  
  RESULTS
  The logMAR (Snellen) visual acuity (mean ± SD) improved significantly with DexNP from 0.41 ± 0.3 (Snellen 0.39) to 0.32 ± 0.25 (0.48) and 0.30 ± 0.26 (0.50) at 4 and 8 weeks, respectively. One-third of the DexNP group improved more than 0.3 logMAR units. For triamcinolone, logMAR changed significantly from 0.42 ± 0.28 (0.38) at baseline to 0.32 ± 0.29 (0.48) at 4w and 0.33 ± 0.37 (0.47) at 12w. The central macular thickness (CMT) decreased significantly with DexNP from 483 ± 141 μm to 384 ± 142 μm at 4w and 342 ± 114 μm at 8w. For triamcinolone, CMT decreased significantly at all time-points: 494 ± 94 μm, 388 ± 120, 388 ± 145, 390 ± 136 and 411 ± 104 μm at 0, 4, 8, 12 and 16 weeks, respectively. There was a modest increase in intraocular pressure (IOP) at all time-points with DexNP while no increase was seen with triamcinolone. Serum cortisol was affected by both treatments.
  
  
  CONCLUSIONS
  Topical DexNP significantly improve visual acuity and decrease macular thickness in patients with DME. The effect is similar to that from subtenon triamcinolone. A modest increase in IOP was seen with the nanoparticle eye drops, but IOP normalized after the discontinuation of treatment.
authors.affiliation: Department of Ophthalmology, Shimane University Faculty of Medicine, Izumo, Shimane, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Ohira
authors.affiliation: Department of Ophthalmology, Shimane University Faculty of Medicine, Izumo, Shimane, Japan.
authors.forename: Katsunori
authors.initials: K
authors.lastname: Hara
authors.affiliation: Department of Clinical Science, Ophthalmology, Umeå University, Umeå, Sweden.
authors.forename: Gauti
authors.initials: G
authors.lastname: Jóhannesson
authors.affiliation: Department of Ophthalmology, Shimane University Faculty of Medicine, Izumo, Shimane, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Tanito
authors.affiliation: Oculis ehf., Reykjavik, Iceland.
authors.forename: Gudrún Marta
authors.initials: GM
authors.lastname: Ásgrímsdóttir
authors.affiliation: Centre of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
authors.forename: Sigrún H
authors.initials: SH
authors.lastname: Lund
authors.affiliation: Faculty of Pharmaceutical Sciences, University of Iceland, Reykjavik, Iceland.
authors.forename: Thorsteinn
authors.initials: T
authors.lastname: Loftsson
authors.affiliation: Department of Ophthalmology, Faculty of Medicine, National University Hospital, University of Iceland, Reykjavik, Iceland.
authors.forename: Einar
authors.initials: E
authors.lastname: Stefánsson
mesh_terms: D000287:Administration, Topical; D000368:Aged; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D056965:Injections, Intraocular; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D012160:Retina / Q000187:drug effects* / Q000473:pathology; D058475:Tenon Capsule / Q000187:drug effects; D041623:Tomography, Optical Coherence; D014222:Triamcinolone Acetonide / Q000627:therapeutic use; D014792:Visual Acuity / Q000187:drug effects* / Q000502:physiology; D047408:gamma-Cyclodextrins / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D047408:gamma-Cyclodextrins; D003907:Dexamethasone; D014222:Triamcinolone Acetonide; C023792:gamma-cyclodextrin
keywords: cyclodextrin; dexamethasone; diabetes macular edema; nanoparticle; topical treatment; triamcinolone