Two randomised, multicentre, double-masked, active-controlled Phase lll studies.
HAWK and HARRIER: prospective head-to-head trials with q12w intervals immediately after loading in eligible patients1*
- Primary endpoint: Change in BCVA from baseline to Week 48, measured by ETDRS letter score2
- Disease activity assessments (DAAs): Anatomical and functional parameters‡ used to determine if patients were eligible for and remained on q12w interval2
Select baseline characteristics
- Simple mean age: 76 years3
- Simple mean VA: 61 letters read; comparable between treatment arms3
- Baseline ocular characteristics for study eye were well balanced across treatment arms3§
- 73% of patients with unilateral wet AMD2
- 93% of patients were diagnosed ≤3 months prior to study entry2
HAWK AND HARRIER
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VA is used to describe BCVA as identified in study protocol.
*Patients were eligible for a q12w interval if no disease activity was observed at Weeks 16 and 20.1
†Beovu arms in HAWK: 3 mg (n=358), 6 mg (n=360); in HARRIER: 6 mg (n=370).1,2 HARRIER, confirmatory analysis in HAWK only (1-sided p values for superiority of Beovu).1
‡Comprehensive DAA criteria at Week 16: Decrease in VA of ≥5 letters compared with baseline; decrease in VA of ≥3 letters and CST increase ≥75 µm compared with Week 12; decrease in VA of ≥5 letters due to wet AMD disease activity compared with Week 12; new or worse IRF/IRC compared with Week 12. DAA criteria at Weeks 20, 32 and 44: Decrease in VA of ≥5 letters due to nAMD activity compared with Week 12.1,3
§Baseline characteristics include, VA (letters read), CST-total, presence of fluid (IRF, SRF, sub-RPE), type of CNV and area associated with CNV lesion1,2
AMD, age-related macular degeneration; BCVA, best corrected visual acuity; CNV, choroidal neovascularisation; CST, central subfield thickness; DAA, disease activity assessment; ETDRS, Early Treatment Diabetic Retinopathy Study; IRC, intraretinal cysts; IRF, intraretinal fluid; nAMD, neovascular age-related macular degeneration; q8w, once every 8 weeks, q12w, once every 12 weeks; RPE, retinal pigment epithelium; SRF, subretinal fluid; VA, visual acuity.
- Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
- Novartis data on file. BRODOF20-002 Core Data Sheet; 2019.
- Dugel PU et al. Ophthalmology. 2020; 127: 72–84 (Supplementary information).