SEP 12, 2018
This study evaluated the effects of a single suprachoroidal injection of a proprietary triamcinolone acetonide suspension (CLS-TA) in patients with macular edema due to noninfectious uveitis.
This multicenter, masked, phase 2 trial enrolled 22 eyes with uveitic macular edema and randomized them (4:1) to a single suprachoroidal injection of a high (4.0 mg) or low (0.8 mg) dose of CLS-TA. Ocular and systemic adverse events were documented for safety analysis. The primary efficacy endpoint was mean change in macular central subfield thickness (CST) at 2 months measured by OCT. Secondary endpoints included percentage of patients who achieved a 20% reduction in CST, percentage of patients with CST of 310 micrometers or less and vision outcomes.
Macular edema due to noninfectious uveitis significantly improved in the 4-mg CLS-TA group; CST decreased by 135 micrometers at 1 month (P=0.0056) and by 164 micrometers at 2 months (P=0.0017) from baseline.
The 4-mg cohort had clinically meaningful improvements in visual acuity, with a gain of approximately 9 ETDRS letters from baseline at 2 months. There was a relatively high number of adverse events, though most were mild or moderate in severity. Of the 22 patients, 13 experienced at least 1 adverse event.
This study is limited by its small size, short duration and limited range of uveitic conditions. Use of a standard of care treatment arm (e.g., intravitreal or periocular corticosteroids) might have helped to establish the clinical relevance of this triamcinolone formulation and its delivery route in comparison with current treatment options.
While these findings suggest that suprachoroidal delivery of corticosteroids may be an effective treatment for uveitic macular edema, the treatment’s ultimate promise—avoiding the adverse ocular side effects of steroids such as cataract and glaucoma—has yet to be realized. The role of suprachoroidal delivery of CLS-TA in clinical practice remains to be determined. More data will be provided by the ongoing phase 3 trial (NCT02595398).