Ranibizumab for the treatment of wet AMD: a summary of real-world studies

Abstract

Data from real-world studies of ranibizumab in neovascular (wet) age-related macular degeneration suggest that outcomes in clinical practice fail to match those seen in clinical trials. These real-world studies follow treatment regimens that differ from the fixed dosing used in the pivotal clinical trial programme. To better understand the effectiveness of ranibizumab in clinical practice, we conducted a comprehensive evaluation of 12-month outcomes reported in peer-reviewed 'real-world' publications. Key measures included in our analysis were mean change in visual acuity (VA) and the proportion of patients gaining ≥15 letters or losing ≤15 letters. Twenty studies were eligible for inclusion in our study, with 18 358 eyes having sufficient data for analysis of 12-month outcomes. Mean baseline VA ranged from 48.8 to 61.6 Early Treatment Diabetic Retinopathy Study letters. Mean change in VA was between -2.0 and +5.5 letters, with a grand mean of +2.9±3.2, and a weighted mean (adjusted for the number of eyes in the study) of +1.95. Eleven studies reported that 19±7.5 (mean value) of patients gained ≥15 letters, while in 12 studies the mean percentage of patient losing ≤15 letters was 89±6.5%. Our comprehensive analysis of real-world ranibizumab study data confirm that patient outcomes are considerably poorer than those reported in randomised control trials of both fixed and pro re nata regimens.

Figure 1

Study selection flow chart.

Figure 2

Mean change from baseline in visual acuity and number of injections in real-world studies and pivotal randomised controlled studies after 12 months of ranibizumab treatment in patients with wet AMD. *Represents average data for the 20 studies included in the current review (see Table 3).

Figure 3

(a) Percentage of patients gaining ≥15 letters. *Represents average data for the 11 studies included in the current review which reported this outcome (Table 3). (b) Percentage of patients losing <15 letters. *Represents average data for the 12 studies included in the current review, which reported this outcome (Table 3).