Purpose
Retrospective studies investigating intraocular pressure (IOP) events after intravitreal triamcinolone acetonide injection (IVTA) have reported a wide range of incidence rates. In this study, prospectively gathered data from the Standard of Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study were analyzed to determine incidence, risk factors, and time course of IOP events in patients undergoing IVTA therapy. This will provide guidance for individualized clinical decision-making, follow-up, and patient management.
Methods
The SCORE Study includes two multicenter phase III randomized clinical trials conducted at 75 clinical sites. Participants with retinal vein occlusion-associated macular edema were randomized to standard of care (SOC), 1-mg IVTA, or 4-mg IVTA therapy. Exclusion criteria: baseline IOP>25 mm Hg, history of intravitreal corticosteroid, history of peribulbar corticosteroid within 6 months, history of open-angle glaucoma or steroid-induced IOP elevation, subsequent diagnosis of neovascular glaucoma, and treatment cross-overs. Kaplan-Meier incidence of IOP events at 36 mos in each of the randomized groups was assessed.
Results
Six hundred sixteen subjects met the study criteria and were followed for 24.7+10.3 (SD) mos. Kaplan-Meier incidences of IOP events are shown in the Table and Figure. Incidences of IOP>25 mm Hg at 36 mos were 8%, 12%, and 47% in the SOC, 1-mg IVTA, and 4-mg IVTA groups, respectively. Rates were significantly higher for the 4-mg IVTA group compared with the other groups (P<.0001 for IOP rise>25, >30, >10 mm Hg from baseline, and commencement of IOP-lowering medication).Younger age, 4-mg IVTA treatment, and higher baseline IOP were all found to confer greater risk (P<.05 for all). The median number of days from time of 1st injection to IOP>25 mm Hg was 118 and 35 days in participants treated with 1-mg and 4-mg IVTA, respectively.
Conclusions
In SCORE, risk factors for IOP events included 4-mg IVTA treatment dose, younger age, and higher baseline IOP. Clinicians should be mindful of these factors when assessing risk-benefit of IVTA therapy and also of the need for long-term follow-up of patients at risk for this complication.