title: Incidence, Risk Factors, and Timing of Elevated Intraocular Pressure After Intravitreal Triamcinolone Acetonide Injection for Macular Edema Secondary to Retinal Vein Occlusion: SCORE Study Report 15.
abstract: OBJECTIVE
  The Standard of Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study showed that intravitreal triamcinolone acetonide (IVTA) is effective at reducing macular edema and improving visual acuity in participants with retinal vein occlusion. Secondary analysis of the incidence, risk factors, and timing of intraocular pressure (IOP) elevation occurring after IVTA provides guidance for clinical decision making and management of patients treated with IVTA.
  
  
  OBJECTIVE
  To investigate the incidence, risk factors, and time course of IOP elevation in participants in the SCORE Study.
  
  
  METHODS
  Secondary analysis conducted from August through December 2014 of a prospective, randomized clinical trial featuring an evaluable population conducted at 75 clinical sites. Six hundred eighty-two patients with macular edema secondary to retinal vein occlusion were enrolled in the study. The SCORE Study enrollment period ran from November 4, 2004, to February 29, 2008, with participant follow-up ending February 28, 2009.
  
  
  METHODS
  Study participants were randomized to standard of care, 1 mg of IVTA, or 4 mg of IVTA therapy and followed up for a mean (SD) of 24.7 (10.3) months.
  
  
  METHODS
  Intraocular pressure elevation greater than 10 mm Hg from baseline.
  
  
  RESULTS
  Kaplan-Meier incidences of IOP elevation greater than 10 mm Hg from baseline at 36 months were 0.02 (95% CI, 0.01-0.06), 0.09 (95% CI, 0.05-0.14), and 0.45 (95% CI, 0.38-0.53) in the standard of care, 1-mg IVTA, and 4-mg IVTA groups, respectively. The rates of IOP-related events were higher for the 4-mg IVTA group compared with the other groups (P ≤ .001 for main outcome measure). Younger age, 4-mg IVTA vs 1-mg IVTA treatment, and higher baseline IOP were found to confer greater risk for IOP-related events (P < .05 for all). The median number of days from time of first injection to IOP elevation greater than 10 mm Hg from baseline was 34.0 and 52.5 days in participants treated with 1-mg and 4-mg IVTA, respectively.
  
  
  CONCLUSIONS
  Intravitreal triamcinolone acetonide injection therapy, in particular the 4-mg dose, is associated with an increased risk for IOP elevation. The risk factors for an IOP-related event include higher treatment dose, younger age, and higher baseline IOP. Intraocular pressure-related events may take several months from the time of first IVTA injection to occur. Clinicians should be mindful of these risk factors when assessing the risks and benefits of IVTA therapy and also of the need for long-term follow-up of participants at risk for this complication.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00105027.
authors.affiliation: Illinois Eye and Ear Infirmary, University of Illinois at Chicago School of Medicine.
authors.forename: Ahmad A
authors.initials: AA
authors.lastname: Aref
authors.affiliation: Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania3Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
authors.forename: Ingrid U
authors.initials: IU
authors.lastname: Scott
authors.affiliation: The EMMES Corporation, Rockville, Maryland.
authors.forename: Neal L
authors.initials: NL
authors.lastname: Oden
authors.affiliation: University of Wisconsin, Madison.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Ip
authors.affiliation: University of Wisconsin, Madison.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Blodi
authors.affiliation: The EMMES Corporation, Rockville, Maryland.
authors.forename: Paul C
authors.initials: PC
authors.lastname: VanVeldhuisen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D007429:Intraocular Pressure / Q000187:drug effects*; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000139:chemically induced / Q000453:epidemiology*; D012170:Retinal Vein Occlusion / Q000150:complications / Q000188:drug therapy*; D012307:Risk Factors; D013997:Time Factors; D014065:Tonometry, Ocular; D014222:Triamcinolone Acetonide / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D005938:Glucocorticoids; D014222:Triamcinolone Acetonide