Abstract
Purpose :
Uveitic macular edema (UME) is the most common vision-threatening complication in noninfectious uveitis (NIU). Inflammation plays a key role in UME pathophysiology and is characterized by an increased intraocular level of proinflammatory cytokines, including interleukin-6 (IL-6). Corticosteroids are the mainstay of treatment but lead to well-recognized adverse events. There is a need for effective, noncorticosteroid therapies for UME. Vamikibart (RG6179) is a recombinant, humanized, monoclonal antibody, engineered for intravitreal delivery, that binds to and inhibits IL-6 activity, and was trialed in patients with UME in the phase 1 DOVETAIL study. Preliminary efficacy and safety results from this study1 supported further evaluation. We report the study designs of MEERKAT and SANDCAT, two ongoing phase 3 trials of vamikibart in UME.
Methods :
Two identical, global, randomized, double-masked, sham comparator–controlled phase 3 trials, MEERKAT (study GR44277, NCT05642312) and SANDCAT (study GR44278, NCT05642325), are investigating the efficacy, safety, and Pharmacokinetics/Pharmacodynamics of intravitreal vamikibart in patients with UME (N=225 per study, across 26 countries). Key eligibility criteria include diagnosis of macular edema, defined by macular thickening, associated with NIU, and BCVA scores of 73–19 EDTRS letters. Patients with active or inactive, acute, or chronic NIU of any etiology or anatomical type are eligible to enroll. Patients are randomized into 3 arms: vamikibart 0.25 mg, vamikibart 1 mg, and sham. Study treatment is administered 4 times every 4 weeks through week 12, followed by as needed dosing from week 20–48 (Fig. 1). Predefined rescue criteria allow standard-of-care treatment for patients with worsening BCVA, UME, or inflammation.
Results :
Primary outcome measure is proportion of patients with ≥15 letter BCVA improvement from baseline at week 16. Secondary endpoints include changes in BCVA and central subfield thickness, rescue medications requirements, adverse events, and concentrations of IL-6 and vamikibart in aqueous humor and serum.
Conclusions :
The ongoing global phase 3 MEERKAT and SANDCAT program will evaluate vamikibart and its potential to address the unmet need for effective noncorticosteroid treatments in UME.
Reference
1. Sharma et al. Invest Ophthalmol Vis Sci. 2023 (ARVO)
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.