UK AMD EMR USERS GROUP REPORT V: benefits of initiating ranibizumab therapy for neovascular AMD in eyes with vision better than 6/12

Abstract

Background/aims To study the effectiveness and clinical relevance of eyes treated with good (better than 6/12 or >70 Early Treatment Diabetic Retinopathy Study letters) visual acuity (VA) when initiating treatment with ranibizumab for neovascular age-related macular degeneration (nAMD) in the UK National Health Service. Currently eyes with VA better than (>) 6/12 are not routinely funded for therapy. Methods Multicentre national nAMD database study on patients treated 3–5 years prior to the analysis. Anonymised structured data were collected from 14 centres. The primary outcome was the mean VA at year 1, 2 and 3. Secondary measures included the number of clinic visits and injections. Results The study included 12 951 treatment-naive eyes of 11 135 patients receiving 92 976 ranibizumab treatment episodes. A total of 754 patients had baseline VA better than 6/12 and at least 1-year of follow up. Mean VA of first treated eyes with baseline VA>6/12 at year 1, 2, 3 were 6/10, 6/12, 6/15, respectively and those with baseline VA 6/12 to >6/24 were 6/15, 6/17, 6/20, respectively (p values <0.001 for comparing differences between 6/12 and 6/12–6/24 groups). For the second eyes with baseline VA>6/12, mean VA at year 1, 2, 3 were 6/9, 6/9, 6/10 and those with baseline VA 6/12 to >6/24 were 6/15, 6/15, 6/27, respectively (p values <0.001–0.005). There was no significant difference in the average number of clinic visits or injections between those with VA better and worse than 6/12. Conclusions All eyes with baseline VA>6/12 maintained better mean VA than the eyes with baseline VA 6/12 to >6/24 at all time points for at least 2 years. The significantly better visual outcome in patients who were treated with good baseline VA has implications on future policy regarding the treatment criteria for nAMD patients’ funding.

UK ophthalmology electronic medical records, databases, big data, and Robert L Johnston!

“…Similarly, these audits have confirmed that the visual acuity (VA) at treatment commencement significantly influenced outcomes, although all patients (and VAs) benefited from treatment for nAMD. 3 These reports confirmed what was known anecdotally, that there were differences in treatment numbers, patient retention rates and discharge policies at the different sites. Although these may represent differences in the quality of care of patients, they could also reflect differences in population characteristics as well as difficulties in recording standardized comparable VA measures, or differences in clinical approach, such as being more or less willing to start patients on therapy and continuing patient follow up with lower VA levels.…”

Different Clinical Courses on Long-Term Follow-Up of Age-Related Macular Degeneration Patients Treated with Intravitreal Anti-Vascular Endothelial Growth Factor Injections

“…Lee et al [19] reported retrospective data from a multicenter national study on patients treated with ranibizumab and found that overall the VA outcome was better in eyes with a baseline VA better than 6/12 compared with those with a VA of 6/12 to 6/24 (over 2 and 3 years of treatment for the first and the second eye, respectively). While this observation is in agreement with our findings, the clinical course was somewhat different, with a decreasing trend in VA.…”

Metaanalysis of Real-World Outcomes of Intravitreal Ranibizumab for the Treatment of Neovascular Age-Related Macular Degeneration

“…Restrictions on therapy for patients with nAMD with VA better than 20/30, as mandated by organizations such as National Institute for Health and Care Excellence in the United Kingdom, may adversely affect a group that is most likely to benefit from treatment. 56 This metaanalysis also provides insight into what is achievable in real-life clinical practice when compared with Phase 3 studies. The whole cohort of patients in this metaanalysis gained a mean 5.0 ETDRS letters after 12 months of ranibizumab therapy with a mean number of 5.4 injections and 8.3 visits per year.…”