A Phase IIIb Study to Evaluate the Safety of Ranibizumab in Subjects with Neovascular Age-related Macular Degeneration

Boyer, David S.; Heier, Jeffrey S.; Brown, David M.; Francom, Steven F.; Ianchulev, Tsontcho; Rubio, Roman G.

doi:10.1016/j.ophtha.2009.05.024

Cited by 313 publications

(252 citation statements)

References 7 publications

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“…In the setting of NV-AMD, the safety of pegaptanib has now been validated over 4 years and in some cases in patients receiving 435 injections without the appearance of ocular or systemic safety signals 16,17 that have been reported with the use of the pan-VEGF agents. Although currently available data do not allow for a direct comparison of the safety of the three VEGF antagonists, of particular note is the SAILOR trial, a dedicated study comparing two doses of ranibizumab, which found a tendency towards a higher incidence of stroke recurrence among patients with a history of stroke (9.6% in the 0.5-mg group compared with 2.7% in the 0.3 mg group); the difference, however, was not statistically significant (Boyer D et al, 18 Limitations of this study include its retrospective and uncontrolled design and especially the fact that criteria for retreatment were not standardised across sites. In addition, visual acuity measurement methods varied, and Snellen measurements were converted to ETDRS letters.…”

Section: Discussionmentioning

confidence: 99%

Intravitreal pegaptanib sodium for choroidal neovascularisation secondary to age-related macular degeneration: Pan-European experience

Sivaprasad

Hykin

Saeed

et al. 2009

Eye

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Purpose To evaluate visual outcomes in patients with neovascular age-related macular degeneration (NV-AMD) who were treated with pegaptanib sodium in European clinical ophthalmology practices. Methods Thirteen centres in eight European countries participated in this retrospective study. Medical records for patients with any angiographic subtype of subfoveal choroidal neovascularisation secondary to NV-AMD with visual acuities (study eye) of 20/40-20/320 treated with 0.3 mg pegaptanib as first-line treatment and with at least 24 weeks of follow-up were identified. Anonymised data reflecting at least 24 and up to 54 weeks of follow-up were recorded. Primary end points were visual acuity outcomes at weeks 24 and 54 compared with those reported at week 54 in the vascular endothelial growth factor (VEGF) Inhibition Study in Ocular Neovascularisation (VISION) trial. Results In all, 253 patients were followed for at least 24 weeks; 62 patients completed 54 weeks of follow-up. A mean of 4.4 (SD, 1.8) pegaptanib injections were administered through 24 weeks. Compared with the VISION trial, the European experience showed that 490% of patients in the current cohort lost o15 letters from baseline at both time points compared with 70% in the VISION trial at 54 weeks. Pegaptanib was well tolerated with no reported cases of endophthalmitis, traumatic cataract, or iatrogenic retinal detachment.Conclusions Pegaptanib was found to stabilise vision in a greater percentage of patients and produced greater overall visual improvement in this group of treatment-naive patients with NV-AMD compared with outcomes reported in the VISION trial; however, interpretation of these results should be tempered given the differences in design between this retrospective study and the prospective controlled trial.

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Section: Discussionmentioning

confidence: 99%

Intravitreal pegaptanib sodium for choroidal neovascularisation secondary to age-related macular degeneration: Pan-European experience

Sivaprasad

Hykin

Saeed

et al. 2009

Eye

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“…[10][11][12][13][14][15][16] The grand mean (+2.9 letters) and weighted mean (+1.95 letters) calculated from the changes in VA reported at 12 months in the trials included in this review are considerably lower than those reported in the pivotal Ranibizumab for the treatment of wet AMD V Chong studies of ranibizumab (fixed monthly dosing), 3,4,[6][7][8] with the exception of the PIER study 9,31 (fixed quarterly dosing) that showed a mean loss of 0.2 letters. Specifically, the recently published AURA study conducted in multiple countries and considered a true and current depiction of the real-world use of ranibizumab for the treatment of AMD, clearly demostrated that the VA outcomes are far worse than the ones reported in the landmark trials (MARINA and ANCHOR).…”

Section: Discussionmentioning

confidence: 90%

“…Outcomes of these PRN regimens are variable with mean gains of 2.3-9.3 letters. [10][11][12][13][14][15][16] For example, in the SAILOR study, which utilised a PRN regimen based around quarterly monitoring visits following three initial monthly doses, there was a mean gain of only 2.3 letters. 10 By contrast, the results from the PrONTo 13,14 study (PRN regimen with monthly monitoring visits following three initial monthly doses) were more promising with VA gains approaching MARINA and ANCHOR results (9.3 letters over 12 months).…”

Section: Introductionmentioning

confidence: 99%

“…[10][11][12][13][14][15][16] For example, in the SAILOR study, which utilised a PRN regimen based around quarterly monitoring visits following three initial monthly doses, there was a mean gain of only 2.3 letters. 10 By contrast, the results from the PrONTo 13,14 study (PRN regimen with monthly monitoring visits following three initial monthly doses) were more promising with VA gains approaching MARINA and ANCHOR results (9.3 letters over 12 months). 3,4,[6][7][8] It seems that only regimens with frequent monitoring and strict retreatment criteria can achieve the visual outcomes anywhere near those seen with fixed monthly dosing.…”

Section: Introductionmentioning

confidence: 99%

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Ranibizumab for the treatment of wet AMD: a summary of real-world studies

Chong

2015

Eye

116

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Data from real-world studies of ranibizumab in neovascular (wet) age-related macular degeneration suggest that outcomes in clinical practice fail to match those seen in clinical trials. These real-world studies follow treatment regimens that differ from the fixed dosing used in the pivotal clinical trial programme. To better understand the effectiveness of ranibizumab in clinical practice, we conducted a comprehensive evaluation of 12-month outcomes reported in peer-reviewed 'realworld' publications. Key measures included in our analysis were mean change in visual acuity (VA) and the proportion of patients gaining ≥ 15 letters or losing ≤ 15 letters. Twenty studies were eligible for inclusion in our study, with 18 358 eyes having sufficient data for analysis of 12-month outcomes. Mean baseline VA ranged from 48.8 to 61.6 Early Treatment Diabetic Retinopathy Study letters. Mean change in VA was between − 2.0 and +5.5 letters, with a grand mean of +2.9 ± 3.2, and a weighted mean (adjusted for the number of eyes in the study) of +1.95. Eleven studies reported that 19 ± 7.5 (mean value) of patients gained ≥ 15 letters, while in 12 studies the mean percentage of patient losing ≤ 15 letters was 89 ± 6.5%. Our comprehensive analysis of real-world ranibizumab study data confirm that patient outcomes are considerably poorer than those reported in randomised control trials of both fixed and pro re nata regimens.

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“…Like IVAN, both the SAILOR and SUSTAIN studies suggested an increased risk of stroke with ranibizumab. 13,14 A meta-analysis of the MARINA, ANCHOR, and FOCUS studies found higher rates of strokes with ranibizumab. 15 Closer examination of the data also suggested that ranibizumab protects against myocardial infarction.…”

mentioning

confidence: 99%