title: Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg.
abstract: OBJECTIVE
  To prospectively compare the efficacy and safety of 4 vs 2 mg intravitreal triamcinolone acetonide (TA) injection for diabetic macular edema.
  
  
  METHODS
  Interventional case series.
  
  
  METHODS
  
  
  
  METHODS
  Thirty-two patients with diabetic macular edema unresponsive to laser photocoagulation.
  
  
  METHODS
  Patients were randomly assigned to receive 4 or 2 mg intravitreal TA in one eye (16 patients in each group).
  
  
  METHODS
  The main outcome was central macular thickness (CMT) measured by optical coherence tomography (OCT) at four, 12, and 24 weeks. Secondary outcomes were gain in Early Treatment Diabetic Retinopathy Study (ETDRS) scores, intraocular pressure (IOP), cataract progression, and duration of effect.
  
  
  RESULTS
  Before injection, mean (+/- SD) CMT was 564.5 +/- 119 microm and 522.9 +/- 148.5 microm in the 4- and 2-mg groups, respectively. At four, 12, and 24 weeks after injection, it was 275.0 +/- 79.8, 271.4 +/- 128.7, and 448.7 +/- 146.4 microm, respectively, in the 4-mg group, and 267.3 +/- 82.4, 289.8 +/- 111.4, and 394.7 +/- 178.9 microm, respectively, in the 2-mg group. At no time was the difference in CMT between both groups statistically significant (P> 0.3). The between-group differences in the gain in the ETDRS score and in IOP were not statistically significant either. Diabetic macular edema recurred after a median period of 20 weeks vs 16 weeks in the 4- and 2-mg groups, respectively (P = 0.11).
  
  
  CONCLUSIONS
  In the short term, intravitreal injection of 4 or 2 mg TA does not have different effects on CMT, visual acuity, or IOP.
authors.affiliation: Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Université Paris, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Audren
authors.forename: Amélie
authors.initials: A
authors.lastname: Lecleire-Collet
authors.forename: Ali
authors.initials: A
authors.lastname: Erginay
authors.forename: Belkacem
authors.initials: B
authors.lastname: Haouchine
authors.forename: Rym
authors.initials: R
authors.lastname: Benosman
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bergmann
authors.forename: Alain
authors.initials: A
authors.lastname: Gaudric
authors.forename: Pascale
authors.initials: P
authors.lastname: Massin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002386:Cataract / Q000503:physiopathology; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007267:Injections; D007429:Intraocular Pressure; D008266:Macula Lutea / Q000473:pathology; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D041623:Tomography, Optical Coherence; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D014822:Vitreous Body
chemical_list: D005938:Glucocorticoids; D014222:Triamcinolone Acetonide