Original article
Real-World Outcomes of Ranibizumab Treatment for Diabetic Macular Edema in a United Kingdom National Health Service Setting

https://doi.org/10.1016/j.ajo.2016.09.002Get rights and content

Purpose

To determine visual acuity (VA) and spectral-domain optical coherence tomography (OCT) outcomes with intravitreal ranibizumab for diabetic macular edema (DME) in a United Kingdom National Health Service clinical setting.

Design

Retrospective interventional case series.

Participants

Consecutive patients with DME, treated with the first ranibizumab injection between August 2013 and March 2014 across 4 sites of Moorfields Eye Hospital, London.

Methods

Two hundred eyes of 164 consecutive patients with center-involving DME and VA ≤79 ETDRS letters, central subfield macular thickness (CST) ≥350 μm on Topcon 3D OCT 2000, initiated on a loading phase of 3 intravitreal ranibizumab injections and who had at least 6 months follow-up were reviewed. Subsequent retreatment was guided by VA and OCT with the aim of treating to stability. VA, OCT CST, and macular volume (MV) were recorded at baseline and monthly to 12 months.

Results

The mean VA, mean CST, and mean MV at baseline were 54.4 (± 15.26) letters, 490.16 (± 116.54) μm, and 10.46 (± 2.28) mm3. The mean VA change at 12 months was +6.6 (± 13.35) letters (P = .0003). A total of 40.3% of patients (n = 77) gained ≥10 letters and 25.1% (n = 48) gained ≥15 letters; 8.9% (n = 17) lost ≥10 letters and 6.3% (n = 12) lost ≥15 letters. At 12 months, the mean change in CST and MV were −133.9 (± 160.12) μm (P = .0001) and −1.5 (± 1.96) mm3 (P = .0001), respectively. An average of 7.2 (± 2.3) injections were given over 12 months.

Conclusions

Outcomes with 3 loading injections of 0.5 mg ranibizumab given monthly followed by pro re nata retreatment in a clinical setting are comparable with outcomes from clinical trials.

Section snippets

Study Design

This is a retrospective interventional case series studying the 12-month outcome of consecutive patients with diabetic macular edema in 1 or both eyes, treated with the first ranibizumab injection between August 2013 and March 2014. The study was approved prospectively by the Clinical Audit and Assessment Committee of Moorfields Eye Hospital and registered with the trust clinical audit department (reference no: CA13/MR/45). Patients who had consented to imaging and anonymized data collection

Patient Disposition and Baseline Characteristics

A total of 968 eyes were screened for eligibility and 200 consecutive eyes of 164 patients were included in this study. Baseline characteristics and demographic data for the cohort are summarized in Table 1.

A total of 21.95% of patients (n = 36) had bilateral injections. Table 2 summarizes demographic data in unilaterally vs bilaterally treated eyes. The mean baseline visual acuity was 55.4 (± 13.63) (6/24) in unilateral cases and 52.1 (± 18.23) (6/30) in bilateral cases. One hundred

Discussion

Our data show that the effectiveness of treatment with ranibizumab for diabetic macular edema in a real-world clinical setting is comparable to results seen in the RESTORE, DRCR.net Protocol I, and RELIGHT studies. The visual acuity benefit in our cohort at 1 year was +6.6 letters and was comparable to that seen in the RESTORE study (+6.8 and 6.4 letters in the ranibizumab-only and ranibizumab-with-laser arms, respectively)5 and the RELIGHT study (+4.8 letters)6 at 1 year but approximately 2

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