title: Randomized, double-blind, placebo-controlled clinical trial on the efficacy of 0.5% indomethacin eye drops in uveitic macular edema.
abstract: OBJECTIVE
  The aim of the present randomized, double-blind, placebo-controlled clinical trial was to assess the efficacy and tolerability of 0.5% indomethacin (INDOM) eye drops in adult patients suffering from macular edema (ME) related to different etiology uveitis.
  
  
  METHODS
  Forty-six eyes of 31 adult patients (20 females and 11 males) mean age 39 years, affected by inflammatory ME, were randomized to receive a dose of commercial 0.5% INDOM eye-drops four times per day (16 subjects = 23 eyes) or placebo (the vehicle of INDOM, 15 subjects = 23 eyes) during a 6-month active therapy follow-up. Study assessment at each visit included visual acuity testing (VA), slit-lamp examination, IOP evaluation, and Heidelberg Spectralis optical coherence tomography (OCT) central foveal thickness (CFT) measurement. Any variation in subjective symptoms and tolerability was also detected.
  
  
  RESULTS
  Statistical analysis showed, from baseline to the 6-month visit, a significant reduction in CFT (P < 0.0001) and a significant improvement in VA only in the 0.5% INDOM-treated group; a global reduction of discomfort symptoms was present in both groups (P < 0.001).
  
  
  CONCLUSIONS
  The four times per day administration of 0.5% INDOM eye drops in eyes affected with uveitic ME from different etiologies, compared with placebo, is associated with a significant reduction in ME at the 6-month follow-up visit, as measured by spectral-domain optical coherence tomography (SD-OCT). However, not all eyes showed a complete resolution of ME because of vitreoretinal traction. (https://eudract.ema.europa.eu/index.html number, EUDRACT 2011-001522-20.).
authors: Ophthalmology Department, Uveitis Tertiary Referral Center, Rapallo Hospital, Genova, Italy.
authors: Pia
authors: P
authors: Allegri
authors: Ugo
authors: U
authors: Murialdo
authors: Simona
authors: S
authors: Peri
authors: Rosanna
authors: R
authors: Carniglia
authors: Maria Grazia
authors: MG
authors: Crivelli
authors: Silvia
authors: S
authors: Compiano
authors: Silvia
authors: S
authors: Autuori
authors: Antonio
authors: A
authors: Mastromarino
authors: Monia
authors: M
authors: Zurria
authors: Giuseppina
authors: G
authors: Marrazzo
mesh_terms: D000368:Aged; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage*; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014605:Uveitis / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D014792:Visual Acuity
chemical_list: D016861:Cyclooxygenase Inhibitors; D009883:Ophthalmic Solutions; D007213:Indomethacin
keywords: 0.5% indomethacin eye drops; Spectralis OCT; uveitic macular edema