The Impact of Systemic Factors on Clinical Response to Ranibizumab for Diabetic Macular Edema

Singh, Rishi P.; Habbu, Karishma; Ehlers, Justis P.; Lansang, M. Cecilia; Hill, Lauren; Stoilov, Ivaylo

doi:10.1016/j.ophtha.2016.03.038

Cited by 68 publications

(43 citation statements)

References 14 publications

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“…These results corroborate those of the post hoc analysis of the Rise and Ride study, in which no association was found between systemic factors and the mean change in BCVA over 2 years [6] . This suggests that the visual response to ranibizumab therapy for DME is not influenced by nonocular factors related to the systemic management of diabetes, even in a real-life setting [24] . In this study, we have shown that patients with a baseline BCVA lower than the first quartile threshold had the worst final BCVA, since these patients had a final BCVA of 43 letters (20/125) on average.…”

Section: Discussionmentioning

confidence: 91%

Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting

et al. 2016

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Purpose: The aim of this study was to assess the efficacy and safety of ranibizumab in patients with diabetic macular edema (DME). Methods: We conducted a retrospective analysis of consecutive patients with vision loss due to DME who were treated with ranibizumab. All patients received a loading dose of 3 monthly injections followed by re-treatments on an as-needed basis. The primary endpoint was the change in best-corrected visual acuity (BCVA) at 12 months. Secondary endpoints were the change in central retinal thickness (CRT) and the number of intravitreal injections (IVI) at 12 months. Results: One hundred and six eyes of 78 patients were included. BCVA changed from 48.3 (20/100) letters at baseline to 59.0 letters (20/63) at 12 months (p < 0.0001; mean gain: +10.7 letters), and 38% of the patients had a final BCVA >70 letters. CRT decreased from 519 µm at baseline to 355 µm at 12 months (p < 0.0001). The threshold of the first quartile of the baseline VA was 40 letters. Patients with a baseline VA >40 letters had a higher final VA of 66 ± 14 letters (20/50) versus 43 ± 18 letters (20/125) for patients with a baseline VA ≤40 letters (p < 0.0001). A mean number of 5.4 (3-10) IVI were administered. Conclusion: This study conducted in a clinical setting confirms the results of previous randomized trials. The final BCVA was mainly influenced by the baseline BCVA, which supports the utility of early DME treatment before patients experience a severe vision loss.

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Section: Discussionmentioning

confidence: 91%

Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting

et al. 2016

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“…A recent post-hoc analysis of the RIDE and RISE trials evaluated the effects of systemic factors on vision changes from baseline in DME patients treated with RBZ [10] . The study revealed that the BCVA improvement with RBZ was not influenced by systemic factors, including diabetes medication history, serum glucose, glycosylated hemoglobin, blood pressure, body mass index, and renal function.…”

confidence: 99%

Intravitreal Ranibizumab in Diabetic Macular Edema: Long-Term Outcomes

Zucchiatti¹,

Bandello²

2017

Management of Diabetic Retinopathy

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Intravitreal ranibizumab (RBZ) has been shown in multiple randomized clinical trials to be a valuable treatment for diabetic macular edema (DME), promoting a significant improvement in best-corrected visual acuity (BCVA) and in anatomic outcomes. Compared to sham (RISE and RIDE studies), RBZ rapidly and sustainably improved BCVA and decreased macular edema at 2 years, reducing the risk of further vision loss, with low rates of local or systemic side effects. Compared to macular laser photocoagulation (READ-2 study), RBZ provided a greater improvement in BCVA and regression in foveal thickness, but required a higher number of injections compared to patients treated with both RBZ and laser. In RESTORE trial, RBZ alone or combined with macular laser turned out to be superior to laser alone, without significant differences between the 2 RBZ groups. Compared to combined treatment (RBZ or triamcinolone associated with macular laser) or photocoagulation laser alone (Diabetic Retinopathy Clinical Research Network trial), RBZ with prompt or deferred laser was more effective than laser alone at 1-year follow-up. At 3 years, prompt laser was not better than deferring laser for 24 weeks or more. At 5 years, subjects treated with RBZ achieved better long-term visual outcomes than patients managed with triamcinolone or laser followed by very deferred RBZ. In conclusion, randomized clinical trials showed that RBZ was superior to laser in DME treatment, providing excellent long-term visual outcomes. Frequent injections were necessary in most of the patients to properly control DME and maximize the visual benefits.

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“…In particular for DMO, the haemoglobin A1c and blood pressure in pivotal trials can be substantially different from ‘real-world’ patients,9 10 although a recent study suggests this may not affect outcomes of treatment 11. Electronic medical record (EMR) systems, if well-designed, offer more complete, prospective, real-time data collection as a by-product of routine care.…”

Section: Introductionmentioning

confidence: 99%

The United Kingdom Diabetic Retinopathy Electronic Medical Record Users Group, Report 1: baseline characteristics and visual acuity outcomes in eyes treated with intravitreal injections of ranibizumab for diabetic macular oedema

et al. 2016

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The Impact of Systemic Factors on Clinical Response to Ranibizumab for Diabetic Macular Edema

Cited by 68 publications

References 14 publications

Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting

Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting

Intravitreal Ranibizumab in Diabetic Macular Edema: Long-Term Outcomes

The United Kingdom Diabetic Retinopathy Electronic Medical Record Users Group, Report 1: baseline characteristics and visual acuity outcomes in eyes treated with intravitreal injections of ranibizumab for diabetic macular oedema

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