Dataset Information

Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE.

ABSTRACT:

Background

This post hoc analysis compared the efficacy and safety of suprachoroidally administered triamcinolone acetonide (CLS-TA) to other commonly available treatments for non-infectious uveitis.

Methods

Results from the PEACHTREE study were compared between subjects randomised to CLS-TA not requiring rescue therapy and those subjects randomised to control, who subsequently required rescue therapy. Endpoints included best corrected visual acuity (BCVA), central subfield thickness (CST), treatment emergent adverse events and intraocular pressure (IOP) related safety findings.

Results

In this analysis, there were 83 unrescued CLS-TA subjects and 46 rescued control subjects. At Week 24, 51.9% of the unrescued CLS-TA subjects gained ≥15 letters in BCVA, compared to 37.0% of the rescued control subjects (p = 0.115). Unrescued CLS-TA subjects showed a mean gain of 15.7 versus 10.9 letters in rescued control subjects (p = 0.080). A significantly greater mean reduction in CST was observed for unrescued CLS-TA subjects versus rescued control subjects (174.0 and 148.5 μm; p = 0.040). Of unrescued CLS-TA subjects, 4.9% experienced IOP elevations ≥30 mm Hg at any visit versus 10.9% of rescued control subjects. Further, use of IOP-lowering medications appeared lower in unrescued CLS-TA subjects versus rescued control subjects (7.2% vs. 13.0%). There were no IOP-lowering surgical interventions in either group.

Conclusion

CLS-TA subjects experienced significantly greater reduction in CST and tended towards greater improvement in BCVA, compared with rescued control subjects. Suprachoroidally administered CLS-TA showed a lower incidence of IOP-related safety findings.

SUBMITTER: Singer MA

PROVIDER: S-EPMC9305780 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE.

Singer Michael A MA Merrill Pauline P Yeh Steven S Hall Colette C Kapik Barry B Ciulla Thomas A TA

Clinical & experimental ophthalmology 20211227 1

<h4>Background</h4>This post hoc analysis compared the efficacy and safety of suprachoroidally administered triamcinolone acetonide (CLS-TA) to other commonly available treatments for non-infectious uveitis.<h4>Methods</h4>Results from the PEACHTREE study were compared between subjects randomised to CLS-TA not requiring rescue therapy and those subjects randomised to control, who subsequently required rescue therapy. Endpoints included best corrected visual acuity (BCVA), central subfield thickn ...[more]

PMID: 34741564

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Project description:BackgroundSuprachoroidal Drug Delivery has emerged in recent years as a novel promising approach, which may help address the clinical unmet needs in the management of Retinal Vein Occlusion (RVO) associated Macular Edema (ME). In this study, we aim to evaluate the feasibility in regard of the potential efficacy and safety of suprachoroidal injection of Triamcinolone Acetonide (TA) using a microinjector as a mono-treatment of ME due to RVO.MethodsThis trial included 16 eyes of 16 patients with RVO associated ME presenting to the department of ophthalmology, Al Mouwasat university hospital, Syria. 4 mg of preserved TA was injected suprachoroidally 4 mm away from the inferotemporal limbus using a patient-customized microinjector. After injection, patients were followed after 1 week then monthly for 3 months. Primary outcome measures included the percentage of participants with best-corrected visual acuity (BCVA) gain≥15 letters and increased intraocular pressure (IOP) ≥ 20 mmHg in months 1,2, and 3, secondary measures included mean change from baseline BCVA, central subfield thickness (CST), and IOP through each of the follow-up points in addition to other measures.ResultsAfter injection, BCVA gain≥15 letters occurred in 68.7, 62.5, 50, 50% of patients at week 1 and through months 1,2 and 3 respectively, the mean BCVA improved significantly by 16.4, 16, 14.4, and 11.9 letters (p-value< 0.0005) at week 1 and months 1,2 and 3 respectively. This visual gain was associated with a significant reduction of CST by 290.94 ± 181.76 (week-1) (p-value< 0.0005), 274.31 ± 184.60 (month-1) (p-value< 0.0005), 183.50 ± 165.61 (month-2) (p-value = 0.006) and 137,75 ± 156.25 μm (month-3) (p-value = 0.038). We reported one case of increased IOP ≥ 20 mmHg in the first month that decreased in the second month. The mean change of IOP readings was not statistically significant, with an increase ranging from 0.75 mmHg after the first week (p-value = 0.09) and 0.5 mmHg after 3 months (p-value = 0.72).ConclusionThis study suggests that suprachoroidal TA could be well tolerated and efficacious as a mono-treatment of RVO associated ME. Future clinical trials are required to confirm its longer-term safety and efficacy and to compare this efficacy with the other therapeutic options.Trial registrationThis study was retrospectively registered at clinicaltrials.gov (ID: NCT05038072) on 08/09/2021. This article was published as a preprint on 22/06/2022. https://doi.org/10.21203/rs.3.rs-1701105/v1 .

Project description:PURPOSE:To evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI). DESIGN:Multicenter, randomized clinical trial. PARTICIPANTS:Patients with uveitic ME. METHODS:Patients were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME were assigned the same treatment for both eyes. MAIN OUTCOME MEASURES:The primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at baseline) assessed with OCT by masked readers. Secondary outcomes included ?20% improvement and resolution of ME, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks. RESULTS:All treatment groups demonstrated improved CST during follow-up. At 8 weeks, each group had clinically meaningful reductions in CST relative to baseline (PropBL: 0.77, 0.61, and 0.54, respectively, which translates to reductions of 23%, 39%, and 46% for PTA, ITA, and IDI, respectively). Intravitreal triamcinolone acetonide (PropBL ITA/PropBL PTA, hazard ratio [HR], 0.79; 99.87% confidence interval [CI], 0.65-0.96) and IDI (PropBL IDI/PropBL PTA, HR, 0.69; 99.87% CI, 0.56-0.86) had larger reductions in CST than PTA (P < 0.0001). Intravitreal dexamethasone implant was noninferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, HR, 0.88; 99.87% CI, 0.71-1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic ME. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than in the PTA group at 8 weeks (P < 0.004). The risk of having IOP ?24 mmHg was higher in the intravitreal treatment groups compared with the periocular group (HR, 1.83; 95% CI, 0.91-3.65 and HR, 2.52; 95% CI, 1.29-4.91 for ITA and IDI, respectively); however, there was no significant difference between the 2 intravitreal treatment groups. CONCLUSIONS:Intravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic ME with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments.

Dataset Information

Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE.

Background

Methods

Results

Conclusion

Publications

Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE.

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