Table 1.
Characteristics of Included Random Controlled Trials Regarding the Efficacy and Safety Outcomes of intravitreal Faricimab and Anti-VEGFS Treatment.
| Source | Study design | Study population | Intervention | Follow-up, weeks | Main outcomes | |||
|---|---|---|---|---|---|---|---|---|
| Experimental | Sample size | Controlled | Sample size | |||||
| Sahni, et al.19 (AVENUE) | Phase 2 RCT | Treatment-naïve Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration | Arm B: Faricimab, 1.5 mg every 4 weeks | Arm B: 47 | Arm A: | 68 | 36 | Mean BCVA (ETDRS) change (compared to Arm A): |
| Arm C: Faricimab, 6.0 mg every 4 weeks | Arm C: 42 | Ranibizumab, 0.5 mg every 4 weeks | Arm B: 1.6 (80% CI, − 1.6 to 4.7) letters | |||||
| Arm D: Faricimab, 6.0 mg every 4 weeks up to week 12, followed by 6 mg every 8 weeks | Arm D: 47 | Arm C: − 1.6 (80% CI, − 4.9 to 1.7) letters | ||||||
| Arm E: Ranibizumab 0.5 mg + Faricimab 6.0 mg every 4 weeks | Arm E 69 | Arm D: − 1.5 (80% CI, − 4.6 to 1.6) letters | ||||||
| Arm E: − 1.7 (80% CI, − 3.8 to 0.4) letters | ||||||||
| Khanani et al.20 | Phase 2 RCT | Treatment-naive CNV secondary to AMD (nAMD) | Arm B: Faricimab, 6.0 mg every 12 weeks | Arm B: 29 | Arm A: | 16 | 52 | Mean BCVA (ETDRS) change (compared to Arm A): |
| (STAIRWAY) | Arm C: Faricimab, 6.0 mg every 16 weeks | Arm C: 31 | 0.5 mg Ranibizumab every 4 weeks | Arm B: 0.5 (80% CI, –4.3, 5.3) letters | ||||
| Arm C: 1.8 (80% CI, –2.7, 6.4) letters | ||||||||
| Heier et al.21 | Phase 3 RCT | Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye | Faricimab 6.0 mg up to every 16 weeks, based on activity assessments | 331 | Aflibercept 2.0 mg every 4 weeks up to week 8, followed by fixed 8-week dosing to study end | 327 | 48 | Mean BCVA (ETDRS) change: |
| (LUCERNE) | Faricimab group: 6·6 letters (95% CI 5·3 to 7·8) | |||||||
| Aflibercept: 6·6 letters (5·3 to 7·8) | ||||||||
| (treatment difference 0·0 letters [95% CI –1·7 to 1·8]) | ||||||||
| Heier, et al.21 | Phase 3 RCT | Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye | Faricimab 6.0 mg up to every 16 weeks, based on activity assessments | 334 | Aflibercept 2·0 mg every 4 weeks up to week 8, followed by fixed 8-week dosing to study end | 337 | 48 | Mean BCVA (ETDRS) change: |
| (TENAYA) | Faricimab group: 5·8 letters (95% CI 4·6 to 7·1) | |||||||
| Aflibercept group: 5·1 letters (3·9 to 6·4) (treatment difference 0·7 letters [95% CI − 1·1 to 2·5]) | ||||||||