Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study

Li, Xiaoxin; Dai, Hong; Li, Xiaorong; Han, Mei Lan K.; Li, Jun; Suhner, Andrea; Lin, Renxin; Wolf, Sebastian

doi:10.1007/s00417-018-04213-x

Cited by 24 publications

(19 citation statements)

References 20 publications

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“…The REFINE was a phase III, 12-month, double-masked, multicenter, laser-controlled study conducted on Chinese patients with DME. Patients were randomly assigned (4.1) to receive intravitreal ranibizumab injections or laser [ 64 ]. The mean BCVA improvement with ranibizumab at month 12 (+7.9 letters) was statistically significantly greater ( p < 0.001) than that observed with laser (+2.5 letters) [ 64 ].…”

Section: Treatment Strategies Of Dmementioning

confidence: 99%

“…As regards the safety profile, the incidence and characteristics of the adverse events were similar to that observed with bevacizumab. Systemic VEGF inhibition-related adverse events such as stroke and myocardial infarction have been described with the administration of ranibizumab [ 45 – 64 ]. The most commonly reported ocular adverse event among the different studies was conjunctival hemorrhage.…”

Section: Treatment Strategies Of Dmementioning

confidence: 99%

“…The most commonly reported ocular adverse event among the different studies was conjunctival hemorrhage. Other ocular side effects included endophthalmitis, ocular hypertension, and retinal detachment [ 45 – 64 ].…”

Section: Treatment Strategies Of Dmementioning

confidence: 99%

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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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Section: Treatment Strategies Of Dmementioning

confidence: 99%

Section: Treatment Strategies Of Dmementioning

confidence: 99%

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Intravitreal Therapy for Diabetic Macular Edema: An Update

Furino

Boscia

Reibaldi

et al. 2021

Journal of Ophthalmology

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“…Most studies found anti-VEGFs to be superior to laser treatment in DME patients. The REFINE study was conducted in Chinese patients with DME who received intravitreal ranibizumab injections or LP [27]. The results revealed a significantly greater improvement in mean best-corrected visual acuity (BCVA) at month 12 with ranibizumab than with LP [27].…”

Section: Diabetic Macular Edemamentioning

confidence: 99%

“…The REFINE study was conducted in Chinese patients with DME who received intravitreal ranibizumab injections or LP [27]. The results revealed a significantly greater improvement in mean best-corrected visual acuity (BCVA) at month 12 with ranibizumab than with LP [27]. Singh and colleagues reported that BCVA improvement was significantly greater with aflibercept than with laser techniques and was not influenced by any baseline factors [28,29].…”

Section: Diabetic Macular Edemamentioning

confidence: 99%

Treatment of Macular Edema in Vascular Retinal Diseases: A 2021 Update

Grzybowski

Markeviciute

Žemaitienė

2021

JCM

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Macular edema (ME) is associated with various conditions; however, the main causes of ME are retinal vein occlusion (RVO) and diabetes. Laser photocoagulation, formerly the gold standard for the treatment of ME, has been replaced by anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections. Despite its efficiency, this treatment requires frequent injections to preserve the outcomes of anti-VEGF therapy, and as many patients do not sufficiently respond to the treatment, ME is typically a chronic condition that can lead to permanent visual impairment. Generalized recommendations for the treatment of ME are lacking, which highlights the importance of reviewing treatment approaches, including recent anti-VEGFs, intravitreal steroid implants, and subthreshold micropulse lasers. We reviewed relevant studies, emphasizing the articles published between 2019 and 2021 and using the following keywords: macular edema, diabetic macular edema, retinal vein occlusion, laser photocoagulation, anti-VEGF, and intravitreal injections. Our results revealed that a combination of different treatment methods may be beneficial in resistant cases. Additionally, artificial intelligence (AI) is likely to help select the best treatment option for patients in the near future.

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Cardiovascular Adverse Events With Intravitreal Anti–Vascular Endothelial Growth Factor Drugs

et al. 2021

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IMPORTANCE Systemic safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) is a matter of debate and regular updates are necessary.OBJECTIVE To evaluate systemic adverse events (SAEs) associated with intravitreal anti-VEGF drugs compared with non-anti-VEGF treatments in patients with ocular diseases.DATA SOURCES Electronic searches were conducted in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases from inception to July 7, 2020.STUDY SELECTION Randomized clinical trials conducted in adults with retinal diseases who received intravitreal anti-VEGF drugs.DATA EXTRACTION AND SYNTHESIS Studies and treatment characteristics and outcome data were extracted and analyzed, and study quality was evaluated.MAIN OUTCOMES AND MEASURES Main outcomes were major cardiovascular events (MACEs) and total mortality. Secondary outcomes included nonocular hemorrhage, components of MACEs, other cardiovascular outcomes, serious SAEs, and all SAEs.RESULTS A total of 74 randomized clinical trials were analyzed: 32 trials (43%) included 14 190 patients with age-related macular degeneration (AMD), 24 (32%) included 5424 patients with diabetic retinopathy (diabetic macular edema or proliferative diabetic retinopathy), 17 trials (23%) included 3757 patients with retinal vein occlusion, and 1 trial (1%) included 122 patients with myopic choroidal neovascularization. Anti-VEGF drug administration did not increase MACEs compared with control agents (odds ratio [OR], 1.16; 95% CI, 0.85-1.58) or total mortality (OR, 1.27; 95% CI, 0.82-1.96). There was an interaction (subgroup difference, P = .04) in mortality risk depending on the underlying disease with an increase (OR, 1.80; 95% CI, 1.03-3.16; P = .04) in the risk of death in patients with diabetic retinopathy; however, no increase was observed in patients with AMD or retinal vein occlusion. Administration of anti-VEGF drugs increased the risk of nonocular hemorrhage (OR, 1.46; 95% CI, 1.01-2.10), mainly in patients with AMD.CONCLUSIONS AND RELEVANCE Intravitreal anti-VEGF was not associated with an increase in MACEs in the trials examined herein. Increased mortality in patients with diabetes and nonocular hemorrhages, especially in those with AMD, could represent a safety signal, but the evidence was not strong. However, continued surveillance of SAEs remains warranted.

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Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study

Cited by 24 publications

References 20 publications

Intravitreal Therapy for Diabetic Macular Edema: An Update

Intravitreal Therapy for Diabetic Macular Edema: An Update

Treatment of Macular Edema in Vascular Retinal Diseases: A 2021 Update

Cardiovascular Adverse Events With Intravitreal Anti–Vascular Endothelial Growth Factor Drugs

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