Incidence, Risk Factors, and Timing of Elevated Intraocular Pressure After Intravitreal @entity2995 Injection for Macular @entity4 Secondary to XXXX : SCORE Study Report 15.

@entity1 @entity2994 @entity2995 @entity4
Importance: The Standard of Care vs Corticosteroid for @entity2994 (SCORE) Study showed that intravitreal @entity2995 (IVTA) is effective at reducing macular @entity4 and improving visual acuity in @entity1 with @entity2994 . 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 @entity1 treated with IVTA. Objective: To investigate the incidence, risk factors, and time course of IOP elevation in @entity1 in the SCORE Study. Design, Setting, and @entity1 : 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 @entity1 with macular @entity4 secondary to @entity2994 were enrolled in the study. The SCORE Study enrollment period ran from November 4, 2004, to February 29, 2008, with @entity1 follow-up ending February 28, 2009. Interventions: Study @entity1 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. Main Outcomes and Measures: 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 @entity1 treated with 1-mg and 4-mg IVTA, respectively. Conclusions and Relevance: Intravitreal @entity2995 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 @entity1 at risk for this complication. Trial Registration: clinicaltrials.gov Identifier: NCT00105027.
