Efficacy, Durability, and Safety of Intravitreal Faricimab for Neovascular Age-Related Macular Degeneration: A 12-Month Study. American Journal of Ophthalmology

NCT03823287 | Not reported | Koizumi H et al. (2024)

Koizumi, H., Matsumoto, H., Shinoda, H., Honda, S., Yuzawa, M., Kunikata, H., et al. Efficacy, Durability, and Safety of Intravitreal Faricimab for Neovascular Age-Related Macular Degeneration: A 12-Month Study. American Journal of Ophthalmology, 2024; -:1-15.

Locations

Single-center study in Japan

Study Period

Not reported

Study Design

Prospective, randomized, controlled trial

Study Population

Characteristic:

Type of AMD:

2 (Wet AMD)

AMD Stage:

3 (Late)

Total Sample Size:

133patients (Faricimab: 66, Aflibercept: 67)

Age:

Prospective, randomized, controlled trial

Sex (Male) n%:

Not reported

Experimental Group

Intervention Therapy:

Faricimab 6.0 mg

Dose & Frequency:

Every 4 weeks for the first 3 doses, then every 8–16 weeks based on disease activity

Age (Years):

72.1±7.5

Number of Patients:

Male N %:

54 (81.8%)

Patients Followed Up:

Control Group

Intervention Therapy:

Aflibercept 2.0 mg

Dose & Frequency:

Every 4 weeks for the first 3 doses, then every 8 weeks

Age (Years):

71.8±9.5

Number of Patients:

Male N %:

45 (67.2%)

Patients Followed Up:

Follow-up Time: 112 weeks

Outcomes

Durability

Treated Frequency
At week 112, the proportion of faricimab-treated patients on Q16W dosing was 61.0% and 63.1% in the TENAYA Japan subgroup.

Vision

Best-Corrected Visual Acuity (BCVA)
Mean BCVA change at 24 months (Primary Outcome):
• Faricimab = +7.1 (95%CI: 3.7-10.5) letters
• Aflibercept = +5.2 (95%CI: 1.9-8.6) letters
• Adjusted difference = 1.9 letters (95%CI: -2.9 to 6.7)

Other

N/A

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Not reported

Safety

AEs at week 112
Total number of AEs:
• Faricimab, 320 cases
• Aflibercept, 240 cases
Patients with any ocular AE:
• Faricimab, 31 (47.0%) patients
• Aflibercept, 30 (44.8%) patients
Patients with any treatment-related ocular AE:
• Faricimab,7 (10.6%) patients
• Aflibercept, 6 (9.0%) patients
Patients with any AEs of intraocular inflammation:
• Faricimab,7 (4.5%) patients
• Aflibercept, 0

SAEs at week 112
Total number of AEs:
• Faricimab, 24 cases
• Aflibercept, 20 cases
Patients with any ocular SAE:
• Faricimab: 6 (9.1%) patients
• Aflibercept: 6 (9.1%) patients
Patients with any treatment-related ocular SAE:
• Faricimab: 1 (1.5%) patients
• Aflibercept: 2 (3.0%) patients

Outcomes

Conclusion

Faricimab demonstrated similar efficacy and safety to aflibercept over 12 months, with potential for extended treatment intervals, reducing injection burden for nAMD patients.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Low risk

Note: “Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method.” And “Patient baseline characteristics in TENAYA was generally well balanced”

Missing Outcome Data

Low risk

Note: Evidence that the result was not biased by missing outcome data: “Sensitivity and supplemental analyses to test the robustness of these results were consistent across different methods for handling missing data and intercurrent events.”

Selection of the Reported Results

Low risk Note: Registration with protocol.

Deviations from Intended Observations

Low risk Note: Double masked study and ITT principle was applied for the analysis.

Measurement of the Outcome

Low risk Note: “Masked evaluators at central reading centers independently assessed ocular images obtained throughout the study (color fundus photography, fluorescein angiography, and spectral-domain OCT).”

Overall

Low risk