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Clinical Trial
. 2025 Jan 28;109(2):215-222.
doi: 10.1136/bjo-2023-325128.

Comparison of subconjunctival TRIamcinolone acetonide injection and intravitreal dexamethasone (OZurdex) injection for uveitic and postoperative macular oedema: the TRIOZ study

Chloé Couret  1 , Pierre-Antoine Quintart  2 , Alexandra Poinas  3 , Marie-Anne Vibet  1 , Marie-Laure Le Lez  4 , Pierre Labalette  5 , Bahram Bodaghi  6   7 , Marc Labetoulle  8 , Marie-Bénédicte Rougier  9 , Karine Angioi  10 , Christophe Chiquet  11 , Cherif Titah  12 , Laurent Kodjikian  13 , Stephanie Baillif  14 , Catherine Creuzot-Garcher  15 , Marie-Hélène Errera  16 , Michel Weber  1
Affiliations
Clinical Trial

Comparison of subconjunctival TRIamcinolone acetonide injection and intravitreal dexamethasone (OZurdex) injection for uveitic and postoperative macular oedema: the TRIOZ study

Chloé Couret et al. Br J Ophthalmol. .

Abstract

Aims: To compare effectiveness of subconjunctival triamcinolone acetonide injections and intravitreal injections of dexamethasone 700 µg implants in reducing central macular thickness (CMT) in uveitic and postoperative macular oedema (ME).

Methods: We conducted an open-label, French multicentre randomised comparative trial with a logarithmic CMT non-inferiority margin set at 0.06. Patients were adults with non-infectious inflammatory ME, without any contraindication to the treatments. They were randomised 1:1 to receive either triamcinolone or dexamethasone. The primary endpoint was the difference in CMT among treated eyes between baseline and 2 months, measured with spectral-domain optical coherence tomography. Secondary outcomes included visual acuity, laser flare, vitreous haze, duration of action, tolerance to injections and adverse events.

Results: Between January 2016 and January 2020, 106 patients were enrolled (54 in the triamcinolone group and 52 in the dexamethasone group). Subconjunctival triamcinolone injections seemed to be non-inferior to intravitreal dexamethasone injections, especially at month 3 (and nearly at month 1). Nevertheless, we could not demonstrate it, with a treatment effect at month 2 of 0.05 (0.01 ; 0.09) (p value=0.001). This was corroborated by post hoc analyses in the postoperative subgroup, for whom the non-inferiority was nearly demonstrated at month 2 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 could not demonstrate the non-inferiority of triamcinolone injections at month 2. Nevertheless, they showed some efficacity, particularly in treating postoperative ME, being as safe as dexamethasone injections, without any loss of chance if a therapeutic switch is necessary.

Keywords: Clinical Trial; Drugs; Inflammation; Retina.

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Conflict of interest statement

Competing interests: M-AV: data safety monitoring board member in Comité de Protection des Personnes—Ouest IV since september 2022. Payment for expert testimony by Institut National du Cancer in 2023. BB: grants/contracts with Horus Pharma, AbbVie/Allergan. Consulting fees by Horus Pharma, AbbVie/Allergan, Novartis, Active Biotech, Acelyrin, Roche. Advisory board for Genesight. ML: consulting fees/honoraria/payments for expert testimony by Alcon, Allergan, Bausch & Lomb, DMG, Dompe, Horus Pharma, MSD, Novartis, Quantel, Santen, Shire, Topivert, Théa. Support for attending meetings and/or travel by Bausch & Lomb, Novartis, Théa. M-BR: consulting fees/honoraria/support fort attending meetings by Allergan, Horus Pharma. KA: advisory board in uveitis for Horus Pharma. CChiquet : consulting fees for AbbVie, Amo, Horus Pharma, Théa. Advisory board for Horus Pharma. LK: consulting fees/honoraria by AbbVie, Alimera, Bayer, Novartis, Roche, Théa. Support for attending meetings and/or travel by AbbVie, Bayer, Novartis. Advisory board for Alimera, Bayer, Horus Pharma, Novartis. SB: honoraria by Abbvie, Horus Pharma, Novartis, Roche. Supporting for attending meetings and/or travel by Abbvie, Bayer, Roche. Advisory board for AbbVie, Bayer, Horus Pharma. CPC-G: grants/contracts for the institution with Bayer, Novartis. Consulting fees by AbbVie/Allergan, Alcon, Apellis Pharmaceuticals, Bayer, Horus Pharma, Novartis, Roche, Théa. Honoraria and support for attending meetings and/or travel by Allergan, Bayer, Novartis, Roche. MW: consulting fees/honoraria by AbbVie.

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