A multicenter, single-arm study using a modified faricimab treat-and-extend regimen in patients with macular edema due to central retinal vein occlusion: RVOSTAR study design protocol

TL;DR

This study evaluates a modified treatment regimen using faricimab to maintain vision improvement in patients with macular edema due to retinal vein occlusion.

Contribution

The study introduces a modified treat-and-extend regimen for faricimab in Japanese patients with central or hemi-retinal vein occlusion.

Findings

The modified regimen aims to reduce injection frequency while maintaining vision outcomes.

The study will assess factors affecting visual acuity and treatment intervals over 72 weeks.

Abstract

Anti–vascular endothelial growth factor (anti-VEGF) agents are generally considered to be the first line of therapy for macular edema due to retinal vein occlusion (RVO-ME). However, current anti-VEGF treatment regimens in Japan are unable to maintain long-term vision improvement, particularly in patients with central RVO-ME (CRVO-ME). Faricimab is a dual angiopoietin-2/VEGF inhibitor approved for the treatment of RVO-ME in Japan. The RVOSTAR study is being conducted to evaluate the long-term maintenance of vision outcomes with faricimab using a modified treat-and-extend (T&E) regimen in treatment-naïve Japanese patients with CRVO-ME or hemi–RVO-ME (HRVO-ME) and to assess the factors affecting visual acuity and treatment intervals.

RVOSTAR (Japan Registry of Clinical Trials; jRCTs041250001) is an unmasked, single-arm, multicenter, prospective interventional study. Patients with CRVO-ME or HRVO-ME will 1) receive faricimab 6 mg every 4 weeks (≤6 injections) until ME is resolved; 2) be observed with no treatment until ME reoccurs, based on pre-specified central subfield thickness (CST) criteria; and then 3) be treated according to a T&E regimen up to 72 weeks, with dosing intervals based on time to relapse and adjusted by 4-week increments (minimum interval: every 4 weeks; maximum interval: no limit). Vision outcomes include best-corrected visual acuity (BCVA) and CST. The primary endpoint is the change from baseline in BCVA at week 72. Safety outcomes include ocular and non-ocular adverse events.

RVOSTAR will evaluate the long-term maintenance of vision outcomes with a modified faricimab T&E regimen in patients with CRVO-ME or HRVO-ME while reducing the burden associated with frequent injections. The findings from this study may help to optimize dosing frequency in clinical practice.

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