Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
Summary
This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.
Timeline
- Start
- 2018-10-30
- Primary completion
- 2020-12-21
- Completion
- 2021-07-01
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
Stopped (Business): “Sponsor Decision”
registry analysis (superiority test); Brolucizumab vs Aflibercept; p = 0.4537; Least Squares Mean Difference -0.6 (95% CI -2.1 to 0.9); Pairwise ANOVA reads as missed primary endpoint NCT03710564 ↗
release “Beovu met MERLIN’s primary endpoint of non-inferiority in change in best corrected visual acuity from baseline” reads as met primary endpoint novartis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Subject | Brolucizumab | Other / unclassified | 6 mg | Intravitreal |