Efficacy and Safety of RTH258 Versus Aflibercept - Study 1
Summary
The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
Timeline
- Start
- 2014-12-08
- Primary completion
- 2017-04-22
- Completion
- 2018-03-28
Outcome
Met primary endpoint
registry analysis (non-inferiority test); Brolucizumab 3 mg vs Aflibercept 2 mg; p = 0.0003; Least Squares Mean Difference -0.6 (95% CI -2.5 to 1.3) NCT02307682 ↗
registry analysis (non-inferiority test); Brolucizumab 6 mg vs Aflibercept 2 mg; p <0.0001; Least Squares Mean Difference -0.2 (95% CI -2.1 to 1.8) NCT02307682 ↗
release “As previously announced, HAWK and HARRIER met their primary endpoint of non-inferiority in mean change in BCVA at week 48 with brolucizumab versus aflibercept” novartis.com ↗
release “The EC approval was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint,” novartis.com ↗
Publications
- Khanani AM, Sadda SR, Sarraf D, Tadayoni R, Wong DT, Kempf AS, Saffar I, Gedif K, Chang A. Effect of Brolucizumab and Aflibercept on the Maximum Thickness of Pigment Epithelial Detachments and Sub-Retinal Pigment Epithelium Fluid in HAWK and HARRIER. Ophthalmol Retina. 2025 Jan;9(1):13-21. doi: 10.1016/j.oret.2024.07.012. Epub 2024 Jul 19.
- Yordi S, Cakir Y, Cetin H, Talcott KE, Srivastava SK, Hu J, Ehlers JP. Bacillary Layer Detachment in Neovascular Age-Related Macular Degeneration from a Phase III Clinical Trial. Ophthalmol Retina. 2024 Aug;8(8):754-764. doi: 10.1016/j.oret.2024.02.007. Epub 2024 Feb 13.
- Singh RP, Jhaveri C, Wykoff CC, Gale RP, Staurenghi G, Iida T, Koh A, B G, Gedif K, Singer M. Efficacy Outcomes of Brolucizumab Versus Aflibercept in Neovascular Age-Related Macular Degeneration Patients with Early Residual Fluid. Ophthalmol Retina. 2022 May;6(5):377-386. doi: 10.1016/j.oret.2021.12.014. Epub 2021 Dec 27.
- Mones J, Srivastava SK, Jaffe GJ, Tadayoni R, Albini TA, Kaiser PK, Holz FG, Korobelnik JF, Kim IK, Pruente C, Murray TG, Heier JS. Risk of Inflammation, Retinal Vasculitis, and Retinal Occlusion-Related Events with Brolucizumab: Post Hoc Review of HAWK and HARRIER. Ophthalmology. 2021 Jul;128(7):1050-1059. doi: 10.1016/j.ophtha.2020.11.011. Epub 2020 Nov 15.
- Dugel PU, Koh A, Ogura Y, Jaffe GJ, Schmidt-Erfurth U, Brown DM, Gomes AV, Warburton J, Weichselberger A, Holz FG; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2020 Jan;127(1):72-84. doi: 10.1016/j.ophtha.2019.04.017. Epub 2019 Apr 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Subject | Brolucizumab | Other / unclassified | 3 mg | Intravitreal |
| Subject | Brolucizumab | Other / unclassified | 6 mg | Intravitreal |