36-Week QUASAR Study: High-Dose Aflibercept Noninferior in RVO
Overview
The QUASAR study demonstrated that 8 mg aflibercept is noninferior to the standard 2 mg dose in improving visual acuity in retinal vein occlusion (RVO) patients at 36 weeks, with gains of approximately 17 to 18 ETDRS letters. Both doses showed robust reductions in central retinal thickness (CRT), and safety profiles were consistent with no new signals.
Background
Retinal vein occlusion (RVO) is a high-VEGF disease causing vision loss, treated with anti-VEGF agents like aflibercept. The QUASAR trial evaluated whether higher doses of aflibercept (8 mg) could provide superior or more durable efficacy compared to the standard 2 mg dose. This multicenter, randomized, double-masked study included patients with branch, hemi, and central RVO. The primary endpoint was change in best corrected visual acuity (BCVA) at 36 weeks.
Data Highlights
| Parameter | 2 mg Group | 8 mg Group (3 initial doses) | 8 mg Group (5 initial doses) |
|---|---|---|---|
| Visual Acuity Gain (letters) | ~17-18 | ~17-18 | ~17-18 |
| CRT Reduction (µm) | ~370 | ~370 | ~370 |
| Patients on ≥8 week dosing at Week 36 | N/A | ~90% | ~90% |
| Patients on ≥12 week dosing at Week 36 | N/A | ~70% | N/A |
| Paracentesis Rate (%) | 1% | 0.7% | 0.7% |
| Intraocular Inflammation | Lower than 8 mg groups | Higher than 2 mg group | Higher than 2 mg group |
Key Findings
- 8 mg aflibercept dosing regimens were noninferior to 2 mg dosing in improving BCVA at 36 weeks, with gains of approximately 17-18 letters.
- All groups showed rapid and robust CRT reductions of around 370 µm.
- Approximately 90% of patients in the 8 mg groups maintained at least 8-week dosing intervals by week 36, with nearly 70% in the 8q8 3 group extending to 12 weeks or more.
- No new safety signals were observed; intraocular pressure remained stable with low paracentesis rates (0.7%-1%).
- Intraocular inflammation rates were slightly lower in the 2 mg group compared to the 8 mg groups, with no occlusive retinal vasculitis events reported.
- Data on differences between BRVO and CRVO subgroups are pending further analysis.
Clinical Implications
High-dose aflibercept (8 mg) offers a comparable visual acuity benefit to the standard 2 mg dose in RVO, with potential for extended dosing intervals, which may reduce treatment burden. Safety profiles remain favorable, supporting consideration of higher dosing regimens in clinical practice once licensed. Ongoing data will clarify subgroup responses and longer-term durability.
Conclusion
The QUASAR 36-week results confirm that 8 mg aflibercept is an effective and safe alternative to 2 mg dosing in RVO, with promising potential for extended treatment intervals. Further data at 64 weeks will elucidate long-term outcomes and optimal dosing strategies.
References
- Gale R, QUASAR Study 2023 -- 36-Week Results From QUASAR
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