Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Timeline
- Start
- 2018-07-23
- Primary completion
- 2020-11-11
- Completion
- 2021-10-18
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (non-inferiority test); Brolucizumab 6 mg vs Aflibercept 2 mg; p <0.001; LS mean difference -1.3 (95% CI -2.9 to 0.3); ANOVA; note: 1-sided p-value reads as mixed primary results NCT03481634 ↗
registry analysis (non-inferiority test); Brolucizumab 3 mg vs Aflibercept 2 mg; p = 0.227; LS mean difference -3.3 (95% CI -5.1 to -1.4); ANOVA; note: 1-sided p-value reads as mixed primary results NCT03481634 ↗
release “In KESTREL and KITE, Beovu (brolucizumab) 6 mg met the primary endpoints of non-inferiority” 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 | 3 mg | Intravitreal |
| Subject | Brolucizumab | Other / unclassified | 6 mg | Intravitreal |