Infographic: ranibizumab or bevacizumab treat & extend for neovascular age-related macular degeneration (AMD): LUCAS trial
Not reported | LUCAS-2 Year Results | *Barai I et al. (2024)
Barai, I., Sivaprasad, S. & Henein, C. Infographic: ranibizumab or bevacizumab treat & extend for neovascular age-related macular degeneration (AMD): LUCAS trial. Eye (London, England), doi: https://dx.doi.org/10.1038/s41433-024-03339-z (2024).
Locations
10 ophthalmologic centers in Norway
Study Period
Not reported
Study Design
Multicenter, randomized, double-blind, noninferiority trial
Study Population
Experimental Group
Control Group
Follow-up Time: 2 years
Outcomes
Durability
Number of Injections
Mean injections over 2 years:
• Bevacizumab = 18.2
• Ranibizumab = 16.0
• Difference = +2.2 injections (95% CI: -3.4 to -1.0, p < 0.001).
Patients Treated Interval
Treated every 4 weeks:
• 27% bevacizumab
• 20% ranibizumab
Treated every 12 weeks:
• 10% bevacizumab
• 17% ranibizumab
Significant difference between bevacizumab and ranibizumab at 2 years (p = 0.002)
Vision
Primary Outcome: Best-Corrected Visual Acuity (BCVA)
Mean BCVA change at 1 year:
• Bevacizumab = +7.9 letters
• Ranibizumab = +8.2 letters
• Difference (p = 0.845).
Mean BCVA change at 2 years:
• Bevacizumab = +7.4 letters
• Ranibizumab = +6.6 letters
• Difference = +0.8 letters (95% CI: -4.1 to 2.5, p = 0.634).
Other
N/A
Immunognicity
Not reported
Pharmokinetics
Not reported
Anatomic
Central Retinal Thickness (CRT)
Mean CRT change at 1 year:
• Bevacizumab = -112 µm
• Ranibizumab = - 120 µm
• Difference (p = 0.460).
Mean CRT change at 2 years:
• Bevacizumab = -113 µm
• Ranibizumab = -122 µm
• Difference = +9 µm (95% CI: -32 to 15, p = 0.476).
Safety
More arteriothromboƽc events with ranibizumab 4.1% bevacizumab vs 6.3% ranibizumab; p= 0.289 at 2 years. However, patients treated with ranibizumab more often had a history of myocardial infarction at baseline (p=0.021).
Conclusion
Bevacizumab and Ranibizumab demonstrated equivalent efficacy in visual acuity and CRT reduction when administered per Treat-and-Extend protocol for 2 years. However, Bevacizumab required more injections. No significant difference in serious adverse events was observed.
Risk of Bias Assessment for Primary Outcome
Randomization Process
Low Risk
Note: “The randomization process was computer generated by a third
party at the Norwegian University of Science and Technology, Trondheim, Norway, with the use of the block method and stratified by center.” and “There were no substantial differences between the groups at baseline except that the patients in the ranibizumab group more often had a history of myocardial infarctions than the patients in the bevacizumab group.” However, the myocardial issue couldn’t affect the primary outcome assessment.
Missing Outcome Data
Low risk
Note: Evidence that the result was not biased by missing outcome data: the primary outcome was first analyzed using per-protocol population, then “The same statistical procedure was applied when analyzing the data according to the intention-to-treat principle, using multiple imputing to replace missing observations”
Selection of the Reported Results
Low risk Note: Registration with the protocol.
Deviations from Intended Observations
Low risk Note: “… the patient, the treating ophthalmologist, and the assisting nurse were masked to the drug at all times.” Besides, the ITT principle was applied for the primary analysis “The same statistical procedure was applied when analyzing the data according to intention-to-treat principle, using multiple imputing to replace missing observations”
Measurement of the Outcome
Some concerns Note: “Ophthalmic nurses, who also were masked to the drug and patient records, tested the ETDRS visual acuity.” There is no information on if there is an assessment difference between different study sites. However, it is unlikely that the assessment of the outcome was influenced by the knowledge of the intervention received.
Overall
Some concerns
Categories: Wet AMD