Intraocular Pressure Outcomes After Lampalizumab Injections in Patients With Geographic Atrophy.
Bressler Neil M, Freund K Bailey, Bakri Sophie J, Kim Judy E, Ferrara Daniela, Brittain Christopher, Pickthorn Karen, Lin Hugh, Sun Christy, Martin Jillian
AI Summary
Repeated 0.1mL intravitreous lampalizumab injections for geographic atrophy were studied. Key finding: No significant IOP increase or higher glaucoma/ocular hypertension rates than sham over one year. Clinical relevance: Supports low IOP risk for larger injection volumes.
Abstract
Importance
Intraocular pressure (IOP) elevations of clinical relevance have been observed after the commonly used 0.05-mL volume for intravitreous injections. However, more recently approved intravitreous agents involve volumes from 0.07 to 0.1 mL. It is not well established whether repeated 0.1-mL intravitreous injections may result in IOP-related complications.
Objective
To investigate the effect of 1 year of repeated 0.1-mL intravitreous injections on IOP outcomes.
Design, setting, and participants: This study was a post hoc analysis of 2 clinical trials investigating the IOP safety of intravitreous lampalizumab on geographic atrophy secondary to age-related macular degeneration. Both trials were conducted between 2014 and 2018 and recruited participants who were 50 years or older and had bilateral geographic atrophy. This post hoc analysis was performed between 2018 and 2022.
Interventions
Intravitreous lampalizumab, 0.1 mL, every 4 weeks; lampalizumab, 0.1 mL, every 6 weeks; or sham procedure every 4 weeks or 6 weeks for 48 weeks.
Main outcomes and measures: IOP changes in the 4-week-frequency study arms and ocular adverse events to week 48 in all arms. The hypothesis for this analysis was formulated after data collection.
Results
Among a total of 1851 participants, there was no change in mean pre-injection IOP values through 48 weeks in either arm. The adverse events glaucoma and ocular hypertension were reported for 1.8% of participants treated with lampalizumab and 1.6% of those in the sham arm.
Conclusions and relevance: Over 1 year, IOP increases were rare and did not affect treated participants more frequently than sham arm participants. These findings support the low risk of persistent IOP increases, on average, of intravitreous 0.1-mL injection volumes administered for 1 year in a manner similar to that performed in these clinical trials. These results may be valuable in the design of future therapeutic trials considering this volume for injections particularly as more recently approved agents use volumes of 0.07 to 0.1 mL.
Trial registration: ClinicalTrials.gov Identifiers: NCT02247479 and NCT02247531.
MeSH Terms
Shields Classification
Key Concepts4
Intraocular pressure (IOP) increases were rare and did not affect participants treated with intravitreous lampalizumab (0.1 mL, every 4 or 6 weeks for 48 weeks) more frequently than sham arm participants over 1 year in a post hoc analysis of two clinical trials.
The adverse events glaucoma and ocular hypertension were reported for 1.8% of participants treated with intravitreous lampalizumab (0.1 mL, every 4 or 6 weeks for 48 weeks) and 1.6% of those in the sham arm in a post hoc analysis of two clinical trials.
There was no change in mean pre-injection intraocular pressure (IOP) values through 48 weeks in either arm (intravitreous lampalizumab 0.1 mL or sham procedure) in a post hoc analysis of two clinical trials.
A post hoc analysis of two clinical trials investigated the intraocular pressure safety of intravitreous lampalizumab (0.1 mL) on geographic atrophy secondary to age-related macular degeneration, recruiting 1851 participants aged 50 years or older with bilateral geographic atrophy between 2014 and 2018.
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