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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.
- Clinical Trial
- Drugs
- Inflammation
- Retina
Data availability statement
Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information.
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Data availability statement
Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information.
Footnotes
Contributors CCouret and P-AQ contributed equally to the drafting of the manuscript. AP, M-AV and MW assisted with the drafting of the manuscript. CCouret, AP and MW wrote the trial’s protocol. M-AV realised statistical analysis. CCouret was scientific investigator. M-AV, M-LLL, PL, BB, ML, M-BR, KA, CChiquet, LK, SB, CPC-G, M-HE and MW were principal investigators of the centres. CT was the main coinvestigator of the centre. MW is the study guarantor. All authors read and approved the final manuscript.
Funding This study was supported by a grant from the French Ministry of Health awarded in 2014 (as part of the Hospital Clinical Research Program), no. 14-0365, for the TRIOZ study. This grant was used to fund the TRIOZ clinical trial, for which MW is the coordinating investigator.
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.
Provenance and peer review Not commissioned; externally peer reviewed.
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