Therapeutic efficacy of bevacizumab for age-related macular degeneration: what are the implications of CATT for routine management?

摘要: CATT (Comparison of Age-related macular degeneration [AMD] Treatment Trials) examined the efficacy ranibizumab and bevacizumab for treatment neovascular AMD. This prospective, randomized, but unblinded trial revealed a significant improvement in vision with both treatments terms visual acuity; importantly, patients juxtafoveal choroidal neovascularization (CNV) retinal pigment epithelial detachments were not excluded from study. Monthly drugs resulted similar increases acuity, although angiograms indicated that was superior reducing fluid leakage. As study also differentiated between fixed regimen an as-needed (pro re nata [PRN]) dosing regimen, larger sample size Bonferroni statistical correction necessary. The equivalence PRN to monthly could be confirmed. Almost all frequent deviations protocol (referring retreatment criteria: 25.7-28.5%) under-treatment. Since this applied equally, under-treatment alone explain loss acuity observed arm. generally associated lesion after 12 months compared regimens. investigators accepted drawbacks incomplete masking allow co-payment by Medicare. assessments drug trials are often politically motivated, higher demands non-inferiority superiority design must emphasized. A comparison per-protocol last-observation-carried-forward analysis has yet been published; ongoing subgroup might highlight impact different characteristics. While provided further evidence treatment, differences adverse events two (e.g. rate serious ranibizumab) reported; however, these still have analysed, sizes previous studies needing taken into account. Preclinical imply some their event profiles. possible increased risk ruled out clinical case series because follow-up intervals adequate. large discrepancy price versus US means cost-benefit is warranted. lack quality-of-life data prevented calculation appropriate context its performance ophthalmological setting. Thus, suggests favourable achieved very administration Although there certain safety caveats, focus on analyses obtaining longer expected yield additional information relevance.