Key Points
- QUASAR is a phase 3 randomized clinical trial evaluating aflibercept 8mg in patients with visual impairment due to macular edema secondary to RVO.
- Patients with treatment-naïve BRVO, HRVO, and CRVO were randomized to aflibercept 8mg q8 weeks (after 3 or 5 monthly loading doses) or aflibercept 2mg q4 weeks.
- Over 36 weeks, aflibercept 8mg every 8 weeks (after 3 or 5 monthly loading doses) was non-inferior to aflibercept 2mg every 4 weeks for vision gains.
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Objective
To evaluate aflibercept 8mg in patients with visual impairment due to macular edema secondary to retinal vein occlusion (RVO).
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Study Design
Phase 3 randomized clinical trial. Duration: 18 months.
Subjects
- Inclusion criteria:
- Treatment-naïve macular edema secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks before screening
- BCVA 73–24 letters (approx. 20/40 to 20/320)
- Mean CST ≥ 300 microns (Cirrus/Topcon) or ≥ 320 microns (Spectralis)
- Exclusion criteria:
- Macular disease limiting BCVA recovery or likely to require intervention during study
- Uncontrolled glaucoma (IOP>25mmHg despite treatment) or history of glaucoma surgery
- Intraocular inflammation within 12 weeks of screening
- Any prior ocular treatment for RVO in the study eye
- Any prior topical/intraocular/periocular steroids within protocol-defined windows
Randomization Scheme/Study Interventions
- Randomized to:
- Aflibercept 8mg q8 weeks after 3 monthly loading doses
- Aflibercept 8mg q8 weeks after 5 monthly loading doses
- Aflibercept 2mg q4 weeks
- Aflibercept 8mg arms: dosing intervals could be shortened to q4 weeks if disease progression, or extended per protocol after week 32/40.
Results
- 301 patients: aflibercept 2mg q4 weeks; 293: aflibercept 8mg q8 weeks after 3 monthly doses; 298: aflibercept 8mg q8 weeks after 5 monthly doses.
- Primary endpoint: Mean change in BCVA from randomization through week 36:
- Aflibercept 8mg q8 weeks after 3 monthly doses: +17.0 letters
- Aflibercept 8mg q8 weeks after 5 monthly doses: +19.1 letters
- Aflibercept 2mg q4 weeks: +17.8 letters
- At 36 weeks, mean observed BCVA: 72 (2mg), 73 (8mg/3 doses), 75 (8mg/5 doses)
- 88% (8mg/3 doses) and 93% (8mg/5 doses) maintained on q8 week dosing interval
Conclusions
- QUASAR demonstrated non-inferior vision gains for aflibercept 8mg q8 weeks (after 3 or 5 monthly loading doses) compared to aflibercept 2mg q4 weeks in macular edema secondary to RVO.