Yeh S, Khurana RN, Shah M, et al. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial [published online ahead of print, 2020 Jan 10]. Ophthalmology. 2020;S0161-6420(20)30011-7. doi:10.1016/j.ophtha.2020.01.006
Noninfectious uveitis (NIU) may impair vision due to macular edema and intraocular inflammation. Intravitreal steroids are effective treatments for NIU but have been associated with increased risks of glaucoma and cararact. Suprachoroidal injection of triamcinolone (CLS-TA) has been proposed to allow more targeted delivery of drug to the choroid and retina while limiting steroid exposure to the anterior segment. Yeh and colleagues reported the results of a phase 3 randomized trial to investigate the safety and efficacy of CLS-TA in treating macular edema and inflammation associated with non-infectious uveitis (NIU).
The study population included 160 eyes with NIU and macular edema. Eyes with IOP >22 mmHg were excluded. Patients were randomized 3:2 to the treatment and control groups. The treatment group underwent CLS-TA 4mg (0.1mL of 40mg/mL) at day 0 and week 12. Patients were allowed to take systemic corticosteroids (20mg/day or less of prednisone) and/or stable doses (>2 weeks) of systemic immunomodulatory drugs. Rescue therapy was available beginning at week 4 if the study eye was not improving.
The primary end point was proportion of patients with vision change +15 ETDRS letters from baseline at week 24 which was achieved in 46.9% of the treatment arm and 15.6% of controls (p<0.001). Patients receiving CLS-TA also had a greater reduction in OCT central subfield thickness (153µm vs 18µm). Four weeks after the initial injection, 53% of patients in the treatment arm had resolution of macular edema versus 2% of controls. In the treatment arm, less patients required rescue therapy over the course of the study (13.5% vs 72%).
Elevated IOP associated with corticosteroid occurred in 11.5% for CLS-TA and 15.6% of controls. All patients who experienced the adverse event of elevated IOP in the control group had received rescue therapy with elevated IOP in 27% of control eyes requiring intravitreal or periocular steroid. Cataract incidence was similar between treatment and control (7.3% vs 6.3%). One case of retinal detachment was reported 8 weeks after CLS-TA. It was assessed to be related to the underlying disease.
Suprachoroidal triamcinolone was found to be effective at improving visual acuity and reducing macular edema in patients with NIU and macular edema. While CLS-TA was not compared directly with other local corticosteroid treatments, these results suggest that suprachoroidal corticosteroid is a valuable addition to the available treatment options. Visual acuity and IOP results in patients treated with suprachoroidal triamcinolone in the current study compared favorably to results of patients who received intravitreal triamcinolone or dexamethasone in the Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema Trial. Further research will be helpful to more directly compare available treatment modalities for macular edema in NIU as well as explore further indications for suprachoroidal delivery of drugs to treat chorioretinal disease.
Joshua D. Levinson, MD
The Retina Group of Washington