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

Ahmad A. Aref, Ingrid U. Scott, Neal L. Oden, Michael S. Ip, Barbara A. Blodi, Paul C. Van Veldhuisen

Research output: Contribution to journalArticle

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Abstract

Importance 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. Design, Setting, and ParticipantsSecondary 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. INTERVENTIONS Study participants were randomized to standard of care, 1mg 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 10mmHg from baseline. Results Kaplan-Meier incidences of IOP elevation greater than 10mmHg 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 10mm Hg from baseline was 34.0 and 52.5 days in participants treated with 1-mg and 4-mg IVTA, respectively. CONCLUSIONS AND RELEVANCE 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00105027.

Original languageEnglish (US)
Pages (from-to)1022-1029
Number of pages8
JournalJAMA Ophthalmology
Volume133
Issue number9
DOIs
StatePublished - Sep 1 2015

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Triamcinolone Acetonide
Retinal Vein Occlusion
Macular Edema
Intraocular Pressure
Injections
Incidence
Standard of Care
Therapeutics
Visual Acuity

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

@article{5c5934a0fbfa4b10819d0e1968727740,
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 = "Importance 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. Design, Setting, and ParticipantsSecondary 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. INTERVENTIONS Study participants were randomized to standard of care, 1mg 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 10mmHg from baseline. Results Kaplan-Meier incidences of IOP elevation greater than 10mmHg 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 10mm Hg from baseline was 34.0 and 52.5 days in participants treated with 1-mg and 4-mg IVTA, respectively. CONCLUSIONS AND RELEVANCE 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00105027.",
author = "Aref, {Ahmad A.} and Scott, {Ingrid U.} and Oden, {Neal L.} and Ip, {Michael S.} and Blodi, {Barbara A.} and {Van Veldhuisen}, {Paul C.}",
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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. / Aref, Ahmad A.; Scott, Ingrid U.; Oden, Neal L.; Ip, Michael S.; Blodi, Barbara A.; Van Veldhuisen, Paul C.

In: JAMA Ophthalmology, Vol. 133, No. 9, 01.09.2015, p. 1022-1029.

Research output: Contribution to journalArticle

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AU - Aref, Ahmad A.

AU - Scott, Ingrid U.

AU - Oden, Neal L.

AU - Ip, Michael S.

AU - Blodi, Barbara A.

AU - Van Veldhuisen, Paul C.

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N2 - Importance 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. Design, Setting, and ParticipantsSecondary 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. INTERVENTIONS Study participants were randomized to standard of care, 1mg 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 10mmHg from baseline. Results Kaplan-Meier incidences of IOP elevation greater than 10mmHg 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 10mm Hg from baseline was 34.0 and 52.5 days in participants treated with 1-mg and 4-mg IVTA, respectively. CONCLUSIONS AND RELEVANCE 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00105027.

AB - Importance 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. Design, Setting, and ParticipantsSecondary 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. INTERVENTIONS Study participants were randomized to standard of care, 1mg 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 10mmHg from baseline. Results Kaplan-Meier incidences of IOP elevation greater than 10mmHg 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 10mm Hg from baseline was 34.0 and 52.5 days in participants treated with 1-mg and 4-mg IVTA, respectively. CONCLUSIONS AND RELEVANCE 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00105027.

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