Predictive factors of better outcomes by monotherapy of an antivascular endothelial growth factor drug, ranibizumab, for diabetic macular edema in clinical practice

Abstract

Intravitreal ranibizumab (IVR) has been approved for treating diabetic macular edema (DME), and is used in daily clinical practice. However, the treatment efficacies of IVR monotherapy in real-world clinical settings are not well known.The medical records of 56 eyes from 38 patients who received their first IVR for DME between April 2014 and March 2015, and were retreated with IVR monotherapy as needed with no rescue treatment, such as laser photocoagulation, were retrospectively reviewed. The clinical course, best-corrected visual acuity (BCVA), and fundus findings at baseline, before the initial IVR injection, and at 12 months, were evaluated.Twenty-five eyes from 25 patients (16 men; mean age 68.7 ± 9.8 years) who received IVR in the first eye, or unilaterally, without any other treatments during follow-up were included. After 12 months, mean central retinal thickness (CRT), which includes edema, was reduced (P = .003), although mean BCVA remained unchanged. There was a negative correlation between individual changes in BCVA (r = −0.57; P = .003) and CRT (r = −0.60; P = .002) at 12 months compared with baseline values. BCVA changes were greater in individuals with a history of pan-retinal photocoagulation at baseline (P = .026). After adjusting for age and sex, CRT improvement >100 μm at 12 months was associated with a greater CRT at baseline (OR 0.87 per 10 μm [95% CI 0.72–0.97]; P = .018) according to logistic regression analyses; however, better BCVA and CRT at 12 months were associated with a better BCVA (r = 0.77; P < .001) and lower CRT (r = 0.41; P = .039) at baseline, respectively, according to linear regression analyses.IVR monotherapy suppressed DME, and the effects varied according to baseline conditions. Eyes that had poorer BCVA or greater CRT, or a history of pan-retinal photocoagulation at baseline, demonstrated greater improvement with IVR monotherapy. In contrast, to achieve better outcome values, DME eyes should be treated before the BCVA and CRT deteriorate. These findings advance our understanding of the optimal use of IVR for DME in daily clinical practice, although further study is warranted.

Pretreatment Neutrophil-to-Lymphocyte Ratio Predicts Prognosis in Patients with Diabetic Macular Edema Treated with Ranibizumab

“…Campochiaro et al [36] found that DME patients with better BCVA at the baseline improved better after IVR treatment compared with those with worse BCVA at the baseline. Ozawa et al [37] also reported similar results, suggesting that an early IVR treatment may be more efficient in DME patients. However, in the present study, an association between CRT values at the baseline and BCVA or CRT at 24 weeks has not been confirmed.…”

Diabetic macular oedema: evidence‐based treatment recommendations for Asian countries

“…A recent study has also reported that patients with poorer baseline best‐corrected visual acuity (BCVA) experienced greater improvement in BCVA than patients with higher baseline BCVA, but better clinical outcome values can be achieved with early treatment (i.e. before BCVA and central retinal thickness deteriorate) . Additionally, suboptimal early BCVA response to DME treatment has been reported to be an indicator for poorer long‐term visual outcomes than eyes that have a pronounced early response .…”

“…before BCVA and central retinal thickness deteriorate). 20 Additionally, suboptimal early BCVA response to DME treatment has been reported to be an indicator for poorer long-term visual outcomes than eyes that have a pronounced early response. 21 Currently, aflibercept, bevacizumab and ranibizumab are the three anti-VEGF treatments often used in clinical practice.…”

Ranibizumab for the Treatment of Diabetic Macular Oedema in the Real-World Clinical Setting in Portugal: A Multicentre Study

“…However, in the real-life clinical setting, intensive regimen protocols are not possible to be implemented, due to the excessive personal and financial burden on the patients and institutions still associated with approved anti-VEGF medication. In fact, the true outcome of anti-VEGF agents in DME and their practical benefits in regular clinical practice have not been studied very well, and undertreatment is a major risk factor for patients [4, 9]. …”

“…Individuals can be affected by DME in their working years, and the chronic nature of the disease is associated with high costs related to visual disability and treatment burden. These are expected to increase as the global prevalence of diabetes also increases [2-4]. …”