Long-term Outcomes of Ranibizumab Therapy for Diabetic Macular Edema: The 36-Month Results from Two Phase III Trials

Brown, David M.; Nguyen, Quan Dong; Marcus, Dennis M.; Boyer, David S.; Patel, Sunil; Feiner, Leonard; Schlottmann, Patricio G.; Rundle, Amy Chen; Zhang, Jiameng; Rubio, Roman G.; Adamis, Anthony P.; Ehrlich, Jason S.; Hopkins, J Jill

doi:10.1016/j.ophtha.2013.02.034

Cited by 765 publications

(653 citation statements)

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“…2012; Brown et al. 2013; Writing Committee for the Diabetic Retinopathy Clinical Research Network et al. 2015), it may be hypothesized that higher mean BCVA gains might have been observed in the RELATION study if it had completed the planned full 12 months.…”

Section: Discussionmentioning

confidence: 99%

The RELATION study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in NPDR and PDR patients with diabetic macular oedema

Lang

Liakopoulos

Vögeler

et al. 2017

Acta Ophthalmologica

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PurposeTo assess efficacy and safety of intravitreal ranibizumab 0.5 mg plus laser (COMBI) versus laser monotherapy (LASER) in patients with visual impairment due to diabetic macular oedema (DME) in either nonproliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) and to analyse the relevance of inner versus outer retinal thickness.MethodsIn this double‐masked, multicentre phase IIIb study, patients (N = 128) were randomized (2:1) to receive COMBI (n = 85) versus LASER (n = 43). Patients received four initial monthly injections of ranibizumab 0.5 mg (COMBI) or sham (LASER) followed by pro re nata (PRN) injections. In both groups, patients received laser at baseline and additional laser at 3 monthly intervals, as needed. The study was started in 2010 and was prematurely terminated due to approval of ranibizumab for DME.ResultsThe least squares (LS) mean change in mean best‐corrected visual acuity (BCVA) from baseline to month 12 was higher in the COMBI (6.5) versus LASER (2.3) group (LS mean difference: 4.2 [95% CI 0.9; 7.4] letters, p = 0.01, primary end‐point). There was also a tendency in the same direction for the subgroup of 26 patients with PDR (LS mean difference 14.7, p = 0.11). Mean central retinal thickness decreased by 107.3 μm in the COMBI group and by 80.3 μm in the LASER group from baseline to month 12 (p = 0.28). Ranibizumab was well tolerated.ConclusionThis study showed that ranibizumab plus laser is a valuable treatment option for the management of DME. Patients with DME in PDR might also benefit from combined therapy compared to laser alone.

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Section: Discussionmentioning

confidence: 99%

The RELATION study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in NPDR and PDR patients with diabetic macular oedema

Lang

Liakopoulos

Vögeler

et al. 2017

Acta Ophthalmologica

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“…In addition to the Protocol I study described previously, RIDE/RISE (ClinicalTrials.gov: NCT00473330/NCT00473382) were two multicentre studies comparing 0.3 mg and 0.5 mg doses of intravitreal ranibizumab and sham injections with adjunctive focal/grid laser photocoagulation according to perprotocol-specified criteria. Over twice as many participants treated with ranibizumab gained more than 15 letters in visual acuity after 24 months of follow-up compared with the laserrescue group [88].…”

Section: Anti-vegf Therapymentioning

confidence: 93%

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

Bahrami

Zhu

Hong³

et al. 2016

Diabetologia

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Diabetic macular oedema (DMO) is the leading cause of vision loss in patients living with diabetes. DMO results from hyperglycaemia-induced activation of pathways that lead to oxidative stress and release of cytokines, impairing the inner and outer blood-retinal barriers. Improved understanding of the pathophysiological mechanisms leading to DMO have led to the development of effective therapies, including vitreoretinal surgery, laser photocoagulation, intravitreal anti-vascular endothelial growth factor drugs and corticosteroids. Advances in imaging, including fluorescein angiography and optical coherence tomography, have also enhanced diagnosis and management of the condition. Despite these advances, there remain patients who do not respond completely to therapy, reflecting the complex pathophysiology of DMO. These patients may be considered treatment-resistant. In this review, we summarise the pathophysiology of DMO, as well as the available treatments and their mechanism of action. Additionally, we focus on treatment-resistant disease and review the literature on potential options for managing this complication of diabetes.

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“…The efficacy and safety of vascular endothelial growth factor (VEGF) inhibitors in diabetic macular oedema (DMO) is well known from several clinical trials [1][2][3][4][5][6][7] but there are few 'real world' reports from the UK 8,9 following the release of the National Institute for Health and Care Excellence (NICE) guidance. 10 This study reports the outcomes of DMO patients treated with ranibizumab in Derby Teaching Hospitals.…”

Section: P Richardson and C Androulakimentioning

confidence: 99%

Meeting Abstracts

2017

Eye

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P01Real world outcomes with intravitreal ranibizumab in neovascular age related macular degeneration (nAMD) using a monitor-and-extend regimen in stable patients D Varma, J Sandhu, DHW Steel, A Kotagiri, M Habib, T Sandinha and J Smith Sunderland Eye Infirmary, Queen Alexandra Road, Sunderland SR2 9HP, UK Pro re nata (PRN) dosing of ranibizumab with monthly monitoring achieves significant clinical benefits; however, this dosing regimen poses an intensive monitoring and injection burden. This study examined whether a monitor and extend (ME) regimen could enable individualised treatment, with the potential to increase the assessment interval in stable patients with neovascular age-related macular degeneration (nAMD).Prospective electronic data from Sunderland Eye Infirmary, UK, were collected between January 2012 and December 2014 from 360 eyes of 332 nAMD patients. All patients received three monthly injections of ranibizumab followed by three monthly assessment visits. Injection-free patients during the assessment follow-up entered the ME group (n = 204), whereas those who required treatment remained on monthly PRN treatment (n = 156). In the ME group, monitoring was extended by 1 month if there were no signs of disease activity, measured by a best-corrected visual acuity (BCVA) loss 45 letters, new haemorrhage or recurrent fluid on optical coherence tomography.Patient baseline characteristics, including age and lesion type, were well balanced. Mean (SD) baseline visual acuity (VA) and central retinal thickness (CRT) were slightly higher in the PRN group than the ME group (52.27 (11.58) vs 48.11 (16.25) letters and 427.31 (94.83) vs 372.99 (79.64) μm, respectively). In patients treated with the ME regimen, only 3.3% of eyes lost ≥ 15 letters, 12-14% of eyes gained ≥ 15 letters, with 460% of eyes having a higher VA at year 2 than at baseline. There were sustained improvements in VA and CRT in years 1 and 2 compared with baseline. Adverse events were identified in o2% of patients, with two cases of submacular haemorrhage and two cases of retinal pigment epithelial rip. There were no cases of intravitreal (IVT) endophthalmitis in this cohort.In summary, an ME regimen achieved visual and anatomic improvements from baseline that were comparable to monthly PRN dosing with a reduced injection frequency. Adverse events were in line with published benchmark trials. ABSTRACTSEye (2017) 31, S10-S17

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Long-term Outcomes of Ranibizumab Therapy for Diabetic Macular Edema: The 36-Month Results from Two Phase III Trials

Abstract: Proprietary or commercial disclosure may be found after the references.

Cited by 765 publications

References 23 publications

The RELATION study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in NPDR and PDR patients with diabetic macular oedema

The RELATION study: efficacy and safety of ranibizumab combined with laser photocoagulation treatment versus laser monotherapy in NPDR and PDR patients with diabetic macular oedema

Diabetic macular oedema: pathophysiology, management challenges and treatment resistance

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