Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema (TRIOZ)
Purpose
to evaluate the comparative effectiveness of subconjunctival triamcinolone injections and intravitreal injections of dexamethasone 700 µg implants in reducing Central Macular Thickness (CMT) in inflammatory macular edema (ME).
Design: open-label, French multicenter randomized parallel-treatment comparative trial with a logarithmic CMT noninferiority margin set at 0.06.
Study population: adults with noninfectious inflammatory ME (the most affected eye in case of bilateral edema), without any contraindication to the treatments.
Methods
patients were randomized 1:1 to receive either triamcinolone, or dexamethasone.
Results
Main outcomes measures: the primary endpoint was the difference in CMT among treated eyes between baseline and 2 months (M2), measured with spectral-domain OCT. Secondary outcomes included visual acuity, laser flare, vitreous haze, duration of action, tolerance to injections, and above all the risk of adverse events.
Results: between January 2016 and January 2020, 106 patients with inflammatory ME were enrolled (54 in the triamcinolone group, and 52 in the dexamethasone group). Of those, respectively 51 and 50 were included in the FAS analysis. Subconjunctival triamcinolone injections seemed to be noninferior to intravitreal dexamethasone injections, especially at M3 (and nearly at M1). Nevertheless, we couldn’t demonstrate it, with a treatment effect at M2 of 0.05 [0.01 ; 0.09] (p-value = 0.001). This was corroborated by post-hoc analyses, among some subgroups such as the Irvine-Gass one, for whom the noninferiority was nearly demonstrated at M2 with a treatment effect of 0.02 [-0.03 ; 0.08] (p = 0.37). There was no significant difference in the occurrence of adverse effects.
Conclusion
we showed that triamcinolone injections were effective, particularly for Irvine-Gass, being as safe as dexamethasone injections and without any loss of chance if a therapeutic switch to intravitreal dexamethasone implant was necessary. Unfortunately the noninferiority cut off of triamcinolone injections at M2 was not reached.
Conflict of interest
No
Authors 1
Last name
COURET
Initials of first name(s)
C
Country
France
Authors 2
Last name
QUINTART
Initials of first name(s)
PA
Country
France
Authors 3
Last name
WEBER
Initials of first name(s)
M
Country
France
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