A Crossover Design for Comparative Efficacy

Wiley, Henry; Thompson, Darby J. S.; Bailey, Clare; Chew, Emily Y.; Cukras, Catherine A; Jaffe, Glenn J.; Lee, Richard W.; Loken, Erin; Meyerle, Catherine B.; Wong, Wai T; Ferris, Frederick L.

doi:10.1016/j.ophtha.2015.11.021

Cited by 18 publications

(5 citation statements)

References 36 publications

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“…However, available evidence suggests that ranibizumab demonstrates the same or better efficacy than bevacizumab in the treatment of DME. 11 , 21 , 22 Therefore, switches from ranibizumab to bevacizumab may have been due to the cost of treatment rather than to lack of efficacy of ranibizumab.…”

Section: Discussionmentioning

confidence: 99%

Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1)

Blinder¹,

Dugel²,

Chen³

et al. 2017

OPTH

114

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PurposeTo evaluate the efficacy, safety, and injection frequency of vascular endothelial growth factor (VEGF) inhibitors as used in clinical practice for the treatment of diabetic macular edema.MethodsMulticenter (10 sites), retrospective chart review in patients (n=156) who received ≥3 anti-VEGF injections. Data collected for ≥6 months after the first injection included Snellen best-corrected visual acuity (BCVA) and central retinal thickness (CRT) by time-domain or spectral-domain optical coherence tomography (TD-OCT or SD-OCT).ResultsMean number of anti-VEGF injections (627 bevacizumab, 594 ranibizumab, 1 aflibercept) was 5.8 (year 1), 5.0 (year 2), and 3.4 (year 3). Percentage of patients with BCVA of 20/40 or better and CRT ≤250 μm on TD-OCT or ≤300 μm on SD-OCT at the same visit (primary endpoint) ranged from 16.4% to 38.9% after the first 10 injections; 51.9%–62.3% achieved ≥20/40 BCVA and 26.2%–48.0% met CRT criteria. Therapy was well tolerated with 19 treatment-related adverse events (all ocular) reported.ConclusionAnti-VEGF injections were administered less frequently and were less effective than those in the ranibizumab registration trials. After each of the first 9 injections, <25% of patients achieved both BCVA of 20/40 or better and a dry macula. A substantial proportion of patients are suboptimal responders to anti-VEGF therapy; these patients may be candidates for other therapies, including intravitreal corticosteroid and laser therapy.

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Section: Discussionmentioning

confidence: 99%

Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1)

Blinder¹,

Dugel²,

Chen³

et al. 2017

OPTH

114

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“…In the future, more trials will be needed to verify whether IVR was superior to IVB and the therapy effect of IVR was more quickly and more durable for DME after cataract surgery. Many clinical trials compared visual acuity and OCT outcomes associated with IVB vs IVR for the management of DME [26, 27]. IVB and IVR were associated with similar effects on central macular thickness in patients with DME.…”

Section: Discussionmentioning

confidence: 99%

A Systematic Review and Meta-Analysis of Clinical Outcomes of Intravitreal Anti-VEGF Agent Treatment Immediately after Cataract Surgery for Patients with Diabetic Retinopathy

Zhao

Cheng

2019

Journal of Ophthalmology

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Aims. To examine possible benefits of intravitreal anti-vascular endothelial growth factor (VEGF) agent treatment immediately after cataract surgery for patients with diabetic retinopathy (DR). Methods. A comprehensive literature search was performed using the Cochrane collaboration methodology to identify randomized controlled trials (RCTs) and comparative studies of cataract surgery with or without anti-VEGF agent treatment for any diabetic retinopathy. Meta-analyses were performed for clinical outcome parameters including changes in macular thickness (MT), best-corrected visual acuity (BCVA), incidence of diabetic retinopathy and maculopathy progression, laser treatment rate, and other complications. Results. Nine RCTs and 3 nonrandomized comparative studies were identified and used for comparing cataract surgery with intravitreal bevacizumab (IVB) or intravitreal ranibizumab (IVR) treatment (338 eyes, intervention group) to cataract surgery alone (329 eyes, control group). Analysis of all data showed that the mean BCVA at 1 week postoperatively had no statistically significant difference in the two groups, but at 1, 3, and 6 months postoperatively, the mean BCVA was statistically significantly better in the anti-VEGF treatment group than that in cataract surgery alone group. Analysis of all data showed that the mean MT was statistically significantly less in the anti-VEGF treatment group at 1 week and 1, 3, and 6 months postoperatively (P=0.05, P=0.006, P=0.0001, and P=0.0001, respectively); but postoperative clinical outcomes were differentiated from the type of anti-VEGF agents, IVB or IVR, and the existing macular edema preoperatively. Intravitreal anti-VEGF agent treatment statistically significantly reduced the incidence of diabetic retinopathy progression and maculopathy progression compared to the control group (P=0.0003, P<0.00001, respectively). Conclusion. IVB or IVR treatment immediately after cataract surgery may represent a safe and effective strategy to prevent postoperative macular thickening or reduce macular edema and result in greater mean improvements in visual acuity for diabetic patients.

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“…The efficacy and safety of ranibizumab and bevacizumab were compared directly in a randomized, double-masked, 36-week, and 3-period crossover study [ 58 ]. Patients received monthly intravitreal injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg).…”

Section: Treatment Strategies Of Dmementioning

confidence: 99%

“…Patients received monthly intravitreal injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg). The results of this study found a slightly but statistically significant difference in BCVA improvement (difference of 1.3 letters in favor of ranibizumab; p = 0.039) and in the mean CMT reduction (difference of 48 μ m in favor of ranibizumab; p < 0.001) [ 58 ].…”

Section: Treatment Strategies Of Dmementioning

confidence: 99%

Intravitreal Therapy for Diabetic Macular Edema: An Update

Furino

Boscia

Reibaldi

et al. 2021

Journal of Ophthalmology

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Diabetic macular edema (DME) represents a prevalent and disabling eye condition. Despite that DME represents a sight-threatening condition, it is also among the most accessible to treatment. Many different treatment options including photocoagulation, intravitreal medical treatment (either vascular endothelial growth factor inhibitors or corticosteroids therapies), and surgical removal are currently available. Although laser has been considered as the gold standard for many years, over the past several years vascular endothelial growth factor inhibitors (anti-VEGFs) have become first-line therapy. However, many patients do not adequately respond to them. With the development of sustained-release corticosteroid devices, steroids have gained a presence in the management of the DME. We review and update the role of anti-VEGF and intravitreal sustained-release corticosteroid management of DME. According to the currently available scientific evidence, the choice of one anti-VEGF over another critically depends on the baseline best-corrected visual acuity (BCVA). While aflibercept may be the drug of choice in low baseline BCVA, the three anti-VEGFs (bevacizumab, ranibizumab, and aflibercept) provided similar functional outcomes when the baseline BCVA was higher. DEX implants are a valuable option for treating DME, although they are usually seen as a second choice, particularly in those eyes that have an insufficient response to anti-VEGF. The new evidence suggested that, in eyes that did not adequately respond to anti-VEGF, switching to a DEX implant at the time to 3 monthly anti-VEGF injections provided better functional outcomes.

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A Crossover Design for Comparative Efficacy

Cited by 18 publications

References 36 publications

Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1)

Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1)

A Systematic Review and Meta-Analysis of Clinical Outcomes of Intravitreal Anti-VEGF Agent Treatment Immediately after Cataract Surgery for Patients with Diabetic Retinopathy

Intravitreal Therapy for Diabetic Macular Edema: An Update

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