Systemic Therapy and the Efficacy of CLS-TA: Results from the Phase 3 PEACHTREE Clinical Trial
Quan Dong Nguyen, MD, MSc
Quan Dong Nguyen,MD, MSc, Thomas Ciulla, MD, MBA
- Professor of Ophthalmology, Spencer Center for Vision Research, Byers Eye Institute, Wu Tai Neorosciences Institute, Stanford University School of Medicine
- Clearside Biomedical, Inc.
- Purpose: Treatment of uveitis may require a combination of systemic and local therapies. The index analysis explores the efficacy of suprachoroidal (SC) injected CLS-TA, a proprietary suspension of triamcinolone acetonide, in the PEACHTREE trial for noninfectious uveitis, to patients receiving and not receiving other systemic therapies.
- Methods: In PEACHTREE, 160 patients with uveitic macular edema were randomized 3:2 to receive SC injections of CLS-TA or sham treatment at baseline and week 12. Patients were allowed to be included in PEACHTREE if on a low dose corticosteroid or stable dose of immunomodulatory therapy. The primary endpoint was the percentage of patients with an increase of 15 letters in EDTRS best corrected visual acuity (BCVA). Secondary endpoints included mean change from baseline in BCVA and central subfield macular thickness (CST). Post-hoc analyses were performed to evaluate the improvement in BCVA and CST in patients receiving systemic corticosteroid and/or steroid-sparing therapy at baseline, and in patients receiving no systemic therapies.
- Results: Overall, 46.9% of patients in the active arm gained 15 letters at week 24 versus 15.6% in the control. The mean change from baseline BCVA was 13.8 letters, versus 3.0 in the control. The mean CST reduction was 152.6 µm in the active arm vs. 17.9 µm in the control.
- For the post-hoc analyses, 68 patients in the active arm and 49 in the control received no additional systemic therapies (systemic corticosteroid or steroid-sparing). At week 24, the increase in BCVA was 15.6 letters versus 4.9 letters in the control arm (p < 0.001) and reduction in CST was 169.8 µm versus 10.3 µm in the control (p < 0.001).
- Further, 28 patients in the active arm and 15 in the control arm were receiving systemic corticosteroid and/or steroid-sparing therapy at baseline. At week 24, the change in BCVA was +9.4 letters in the active arm versus -3.2 letters in the control arm (p = 0.002) and reduction in CST in the active arm was 108.3 µm versus 43.5 µm in the control arm (p < 0.001).
- Conclusions: These post hoc results corroborate the prespecified study analyses in the PEACHTREE trial. With respect to BCVA and CST, a clinically meaningful relative benefit of CLS-TA over control was noted, with and without systemic corticosteroid or steroid-sparing therapy among patients with uveitic macular edema. Further research is warranted.