Post-hoc Analysis of Association of Baseline Characteristics and IOP Rise with Dexamethasone Implant in Phase 3 Studies
Accept poster if oral is not possible ?
Yes
Purpose
Dexamethasone intravitreal (IVI) implant 0.7 mg (DEX-I, OZURDEX®) is associated with increased intraocular pressure (IOP) in ~30% of treated patients. However, it is unknown whether any patient characteristics may aid in predicting increased risk of a rise in IOP. This study used pooled data from the Phase 3 trials to investigate association with baseline (BL) characteristics
Methods
Associations of BL patient characteristics were assessed using univariable and multivariable regression analysis in the intent-to-treat (ITT) population. IOP-lowering medication use and IOP elevation were evaluated
Results
Younger patients [OR(0.92,0.99) P<.03] with higher BL SBP [OR(1,1.03) P<.005] without prior exposure to IVI steroids [OR(0.2,0.9) P<.03] were more likely to use IOP medication during the study. Males with higher BL SBP were more likely to have ≥1 elevated IOP event during the study >30 mmHg [sex OR(1.11,5) P<.03; BL IOP OR(1.02,1.33) P=.02], and younger males were more likely to have a clinically significant increase in IOP from BL >10 mmHg: sex OR(1.17,3.76) P=.013; age OR(0.92,0.99) P<.03]. Males with higher BL IOP and BL IOP medication use were more likely to remain on IOP medication at Year 3 [BL IOP OR(1.11,1.48) P<.001; med OR(2.11,20.36) P=.001].
Conclusion
Higher BL IOP and using IOP meds at BL were associated with use of IOP meds during the study or at Year 3. Higher SBP, male sex, and younger age are factors that may modify physician likelihood to start IOP meds.
Conflict of interest
Yes
Details of conflicting interests
TT: is an employee of AbbVie, owns stock
HL: is an employee of AbbVie
1
Last name
TOY
Initials of first name(s)
B
Department
USC Roski Eye Institute
City
Los Angeles
Country
United States
2
Last name
Hwang
Initials of first name(s)
J
Department
USC Roski Eye Institute
City
los angeles
Country
United States
3
Last name
Treece
Initials of first name(s)
T
Department
Abbvie
City
Irvine
Country
United States
4
Last name
Lai
Initials of first name(s)
H
Department
Abbvie
City
Irvine
Country
United States
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