Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study

Nguyen, Quan Dong; Shah, Syed Mahmood; Heier, Jeffery S.; Diana, V.; Lim, Jennifer I.; Boyer, David S.; Abraham, Prema; Campochiaro, Peter A.

doi:10.1016/j.ophtha.2009.04.023

Cited by 313 publications

(227 citation statements)

References 6 publications

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“…The mean change in BCVA from baseline to month 6 (primary end point) with ranibizumab monotherapy ( þ 7.24 letters) was superior to laser monotherapy (À0.43 letters, P ¼ 0.0001); however, the BCVA change with combination therapy was not significantly different from that of either ranibizumab or laser monotherapy at this timepoint ( þ 3.8 letters; P ¼ 0.08 for both comparisons). 22 In total, 101 patients completed 24 months follow-up; the mean BCVA improvement at month 6 with ranibizumab monotherapy was sustained to month 24 and these improvements were numerically higher than with combination therapy ( þ 7.7 vs þ 6.8 letters, respectively) ( Figure 1a). 23 For the 74 patients who completed 36 months follow-up, mean BCVA continued to improve with mean gains of þ 10.3 letters with ranibizumab monotherapy and þ 9.5 letters with combination therapy vs þ 1.4 letters for patients initially randomised to laser monotherapy ( Table 2).…”

Section: Efficacymentioning

confidence: 98%

“…To date, two phase II studies (RESOLVE 5 and READ-2 22,23 ) and two phase III studies (RESTORE 4 and DRCR.net protocol I 10 ) have been completed using ranibizumabFa total of 1313 patients with DME (Table 1). The trial results discussed are data for the primary and secondary end points, which the clinical trials were sufficiently powered to investigate.…”

Section: Clinical Trial Evidence For Ranibizumab In Dmementioning

confidence: 99%

See 1 more Smart Citation

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

Bandello¹,

Cunha-Vaz

Chong

et al. 2012

Eye

110

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The current standard therapy for patients with diabetic macular oedema (DME)Ffocal/grid laser photocoagulationFusually does not improve impaired vision, and many patients lose vision despite laser therapy. Recent approval of ranibizumab by the European Medicines Agency to treat visual impairment due to DME fulfils the previously unmet medical need for a treatment that can improve visual acuity (VA) in these patients. We reviewed 1-and 2-year clinical trial findings for ranibizumab used as treatment for DME to formulate evidence-based treatment recommendations in the context of this new therapy. DME with or without visual impairment should be considered for treatment when it fulfils the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant oedema. For DME with centre involvement and associated vision loss due to DME, monthly ranibizumab monotherapy with treatment interruption and re-initiation based on VA stability is recommended. Laser therapy based on ETDRS guidelines is recommended for other forms of clinically significant DME without centre involvement or when no vision loss has occurred, despite centre involvement. Because these recommendations are based on randomised controlled trials of 1-2 years duration, guidance may need updating as long-term ranibizumab data become available and as additional therapeutic agents are assessed in clinical trials.

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Section: Efficacymentioning

confidence: 98%

Section: Clinical Trial Evidence For Ranibizumab In Dmementioning

confidence: 99%

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

Bandello¹,

Cunha-Vaz

Chong

et al. 2012

Eye

110

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“…The procedures for intravitreal injections, OCT, and data collection and management have been previously described. 2,5 Sample size calculation The sample size was selected to allow the study to have an 80% power to detect a difference of 4 or more ETDRS letters between the two arms. This size makes the READ-3 study comparable to other clinical trials, as 80% is the typical power employed in many major clinical trials.…”

Section: Study Protocolmentioning

confidence: 99%

“…Randomized clinical trials, such as the Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study, have demonstrated that treatment with an intravitreal VEGF inhibitor (ranibizumab, RBZ) results in superior visual acuity outcomes compared with focal/ grid laser or triamcinolone. [2][3][4][5][6][7] In fact, intravitreal VEGF inhibitors have become the new standard of care for the treatment of center-involved DME, and 0.3 mg RBZ has been approved by the United States Food and Drug Administration (FDA) for DME.…”

Section: Introductionmentioning

confidence: 99%

Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes—Protocol 3 with high dose)

Sepah

Boyer

et al. 2015

Eye

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Purpose To compare 2.0 mg ranibizumab (RBZ) injections with 0.5 mg RBZ for eyes with center-involved diabetic macular edema (DME) and a central subfield thickness (CFT) of ≥ 250 μm on time-domain optical coherence tomography. Design Randomized, controlled, multicenter clinical trial. Methods Eligible eyes were randomized in a 1:1 ratio to 0.5 mg (n = 77) or 2.0 mg (n = 75) RBZ. Study eyes received 6-monthly injections. Main outcome measures The primary outcome measure was the mean change in best corrected visual acuity (BCVA) at month 6. Secondary outcomes included the incidence and severity of systemic and ocular adverse events and the mean change in CFT from baseline. Results In all, 152 eyes (152 patients) were randomized in the study. At month 6, the mean improvement from baseline BCVA was +9.43 letters in the 0.5 mg RBZ group and +7.01 letters in the 2.0 mg RBZ group (P = 0.161). At month 6, one death occurred in the 0.5 mg RBZ group and three deaths in the 2.0 mg RBZ group, all due to myocardial infarction in subjects with a prior history of heart disease. Mean CFT was reduced by 168.58 μm in the 0.5 mg RBZ group and by 159.70 μm in the 2.0 mg RBZ group (P = 0.708). Conclusions There was no statistically significant difference in the mean number of letters gained between the 0.5 and 2.0 mg RBZ groups through month 6. In this DME study population, high-dose RBZ does not appear to provide additional benefit over 0.5 mg RBZ.

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“…The study protocol and primary outcomes have been reported. 13,14 The READ-2 study subjects whose data were included in this vessel calibre analysis included those who had been treated primarily with RBZ alone or in combination with laser and had gradable retinal photographs at baseline.…”

Section: Study Populationmentioning

confidence: 99%

Association of retinal vessel calibre and visual outcome in eyes with diabetic macular oedema treated with ranibizumab

Moradi

Sepah

Ibrahim

et al. 2014

Eye

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Purpose The study aims to identify the association between the baseline retinal vascular calibre and visual outcome of patients with diabetic macular oedema (DMO) treated with intravitreal ranibizumab. Methods The 1-M field (as defined in the ETDRS study) of the digital colour fundus photographs of DMO patients who had been treated primarily with ranibizumab in a clinical trial was assessed. Of the 84 patients, 25 had gradable retinal photographs that could be subjected to analyses by the Interactive Vessel Analysis (IVAN) software at baseline. The average retinal vascular calibre of the six largest venules (CRVE) and the six largest arterioles (CRAE) in the peripapillary area (0.5 and 1 disc diameter from the optic disc margin) was measured. The relationship between CRVE and CRAE at baseline and the change in visual acuity at month 12 was assessed using the Mann-Whitney U test. Results Ten eyes from 10 patients who had shown an improvement of Z2 lines of best corrected visual acuity (BCVA) at month 12 had a wider baseline CRVE (248.3±24.5 mm) compared with the 15 eyes from 15 patients who did not show the improvement of Z2 lines (226.6 ± 44.8 mm, Po0.05). The baseline CRAE did not differ significantly in these patients (156.1 ± 22.7 vs 142 ± 17.5 mm, P ¼ 0.17). Conclusions A wider baseline retinal venular calibre may be a predictor of better visual outcome in DMO eyes treated with ranibizumab. Further prospective studies with a larger sample size and a broader range of disease severity and visual acuity are needed to confirm this finding.

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Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study

Cited by 313 publications

References 6 publications

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel

Month-6 primary outcomes of the READ-3 study (Ranibizumab for Edema of the mAcula in Diabetes—Protocol 3 with high dose)

Association of retinal vessel calibre and visual outcome in eyes with diabetic macular oedema treated with ranibizumab

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