Copyright restrictions may apply JAMA Ophthalmology Journal Club Slides: Elevated Intraocular Pressure After Intravitreal Triamcinolone Acetonide Aref

Copyright restrictions may apply

JAMA Ophthalmology Journal Club Slides:Elevated Intraocular Pressure After Intravitreal Triamcinolone Acetonide

Aref AA, Scott IU, Oden NL, Ip MS, Blodi BA, VanVeldhuisen PC; SCORE Study Investigator Group. 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. JAMA Ophthalmol. Published online June 18, 2015. doi:10.1001/jamaophthalmol.2015.1823.


Introduction

• Macular edema associated with retinal vein occlusion is an important cause of visual morbidity.

• Intravitreal triamcinolone acetonide (IVTA) is an effective therapeutic option.

• Steroid-related intraocular pressure (IOP) rise is an important potential complication.

• Objectives:– To investigate the incidence, timing, and risk factors for IOP elevation

among participants enrolled in the Standard of Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study.

– To provide data that might help guide individualized clinical decision making, follow-up, and patient management.


• The SCORE Study included 2 multicenter phase III randomized clinical trials conducted at 75 clinical sites.– Compared standard of care (SOC) treatment with IVTA for the

treatment of macular edema due to retinal vein occlusion.

• Eyes were randomized to treatment with 1-mg IVTA, 4-mg IVTA, or SOC.– For branch retinal vein occlusion, SOC was grid laser macular

photocoagulation.– For central retinal vein occlusion, SOC was observation.

Methods


• IOP measurements:– 4-month intervals after randomization.– Safety visits 4 days (±3 days) after each injection and 4 weeks (±1 week)

after each injection.

• Kaplan-Meier analysis was performed to estimate cumulative incidences at 36 months:– IOP rise >10 mm Hg from baseline.– Maximum IOP rise >25 mm Hg.– Maximum IOP rise >30 mm Hg.

• Log-rank test was used to test for differences among treatment groups.

• Day 4 visit data were excluded

• Cox multivariate regression analysis was used to investigate the effect of treatment assignment on risk of IOP event.

Methods


• The SCORE Study enrolled 682 participants in the BRVO (n = 411) and CRVO (n = 271) trials.

• 616 participants met present study criteria.

• Mean (SD) follow-up duration was 24.7 (10.3) months.

• Mean (SD) of 3.2 (2.0) injections were received among participants randomized to IVTA.

Results


Baseline and Demographic Characteristics of Participants Who Experienced an IOP-Related Event in the SCORE Study

Results


Results• Cumulative incidences of IOP >10 mm Hg from baseline at 36 months:

– SOC: 0.02 (95% CI, 0.01-0.06).– 1-mg IVTA: 0.09 (95% CI, 0.05-0.14).– 4-mg IVTA: 0.45 (95% CI, 0.38-0.53).– P < .001 for difference among treatment groups.

• Kaplan-Meier Analysis Depicting IOP Elevation >10 mm Hg Above Baseline According to Treatment Group


Multivariate Cox Regression Analysis for Risk of IOP-Related Events in SCORE Study

Results


Timing of IOP Elevation >10 mm Hg Above Baseline After First Injection

Results

Group

Timing, d

Minimum25th

Percentile50th

Percentile75th

Percentile Maximum Mean (SD)

All eyes (n = 48) 21 33 42 117 598 80 (90)

1-mg IVTA (n = 10) 21 29 34 126 598 126 (181)

4-mg IVTA (n = 38) 26 35 52.5 110 135 69 (40)


• Higher incidence of IOP-related events occurring after 4-mg IVTA therapy compared with the 1-mg dose and no injection of steroid for macular edema–associated retinal vein occlusion.

• Lower treatment dose should be strongly considered, but close long-term follow-up is still warranted.

• Limitations of the study include a lack of structural and functional measures of optic nerve health in those with an IOP event.

Comment


• If you have questions, please contact the corresponding author:– Paul C. VanVeldhuisen, PhD, The EMMES Corporation, 401 N Washington St,

Ste 700, Rockville, MD 20850 ([email protected]).

Funding/Support• The SCORE Study was funded by the National Eye Institute (National Institutes of

Health, Department of Health and Human Services) grants 5U10EY014351, 5U10EY014352, and 5U10EY014404. Financial support was also provided in part by Allergan Inc through donation of investigational drug and partial funding of site monitoring visits and secondary data analyses. Dr Aref is supported by National Institutes of Health Core Grant EY001792 and an unrestricted grant from Research to Prevent Blindness in preparation of this article. Drs Scott and VanVeldhuisen have received grant support from the National Eye Institute.

Conflict of Interest Disclosures• None reported.

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Copyright restrictions may apply JAMA Ophthalmology Journal Club Slides: Elevated Intraocular Pressure After Intravitreal Triamcinolone Acetonide Aref