Measuring the benefit of 4 years of intravitreal ranibizumab treatment for neovascular age-related macular degeneration

Pushpoth, Sreekumari; Sykakis, Evripidis; Merchant, Kinnar; Browning, Andrew C.; Gupta, Rajen K.; Talks, S J

doi:10.1136/bjophthalmol-2012-302167

Cited by 35 publications

(37 citation statements)

References 12 publications

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“…Holz et al 13 also reported that 11.7% (n = 199) of their patients had both occult and classic lesions. Heimes et al 14 and Pushpoth et al 15 reported the combined number of patients with either predominantly or MC lesions. These two values could not be separated and were therefore excluded from the analysis of lesion type.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

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Metaanalysis of Real-World Outcomes of Intravitreal Ranibizumab for the Treatment of Neovascular Age-Related Macular Degeneration

Kim

Mehta

Barthelmes

et al. 2016

Retina

161

157

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PURPOSE: To report the efficacy and safety of intravitreal ranibizumab for neovascular agerelated macular degeneration (nAMD) in real-world practice. METHODS: Metaanalysis of 26,360 patients from 42 real-world observational studies reporting outcomes of intravitreal ranibizumab for nAMD published between 2007 and 2015. Baseline demographics, lesion type, and visual acuity (VA) were recorded. The weighted mean was calculated for change in VA and frequency of injections and visits during year 1, year 2, and 3 years. Local and systemic adverse events were recorded. RESULTS: The mean change in VA for patients receiving a treat-and-extend regimen was +8.8 (95% confidence interval [CI]: 5.8 to 11.8), +6.7 (95% CI: 3.2 to 10.1), and +5.4 (95% CI: -4.1 to 14.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 1 year (n = 1,539), 2 years (n = 2,521), and 3 years (n = 1,298), in comparison with +3.5 (95% CI: 2.0 to 5.0), +1.3 (95% CI: -1.6 to 4.2), and -1.9 (95% CI: -9.8 to 6.0) ETDRS letters for pro re nata at 1 year (n = 20,247), 2 years (n = 14,408), and 3 years (n = 11,714). Treat-and-extend patients received on average more injections (6.9 vs. 4.7) but had fewer visits (7.6 vs. 9.2) in the first year. Baseline characteristics were similar between the regimens. The reported rate of endophthalmitis was 17 of 66,176 intravitreal injections (0.026%). CONCLUSION: Intravitreal ranibizumab for nAMD prevents severe visual loss in real-world practice. Patients can achieve visual gain from baseline, but the extent to which these are maintained in the long term may depend on the frequency of injections. Methods: Metaanalysis of 26,360 patients from 42 real-world observational studies reporting outcomes of intravitreal ranibizumab for nAMD published between 2007 and 2015. Baseline demographics, lesion type, and visual acuity (VA) were recorded. The weighted mean was calculated for change in VA and frequency of injections and visits during year 1, year 2, and $3 years. Local and systemic adverse events were recorded.Results: The mean change in VA for patients receiving a treat-and-extend regimen was +8.8 (95% confidence interval [CI]: 5.8 to 11.8), +6.7 (95% CI: 3.2 to 10.1), and +5.4 (95% CI: 24.1 to 14.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 1 year (n = 1,539), 2 years (n = 2,521), and $3 years (n = 1,298), in comparison with +3.5 (95% CI: 2.0 to 5.0), +1.3 (95% CI: 21.6 to 4.2), and 21.9 (95% CI: 29.8 to 6.0) ETDRS letters for pro re nata at 1 year (n = 20,247), 2 years (n = 14,408), and $3 years (n = 11,714). Treat-andextend patients received on average more injections (6.9 vs. 4.7) but had fewer visits (7.6 vs. 9.2) in the first year. Baseline characteristics were similar between the regimens. The reported rate of endophthalmitis was 17 of 66,176 intravitreal injections (0.026%).Conclusion: Intravitreal ranibizumab for nAMD prevents severe visual loss in real-world practice. Patients can achieve visual gain from baseline, but the extent to which these are maintained in the long...

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Section: Baseline Characteristicsmentioning

confidence: 99%

“…These two values could not be separated and were therefore excluded from the analysis of lesion type. Pushpoth et al, 15 Katz et al, 16 and Abedi et al 17 reported the combined number of patients with MC or occult lesions, and these were included into the occult category for analysis.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

Metaanalysis of Real-World Outcomes of Intravitreal Ranibizumab for the Treatment of Neovascular Age-Related Macular Degeneration

Kim

Mehta

Barthelmes

et al. 2016

Retina

161

157

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“…For example, patients with good baseline acuity demonstrated a smaller improvement in response to ranibizumab than patients with poor baseline acuity, 29,32 while treatmentnaive patients showed a better response than previously treated individuals. 26 Differences such as these may obscure the effects of treatment if the numbers of patients from a particular group are unrepresentative of the population as a whole. However, with nearly 20 000 patients analysed, the real-life data reviewed here could be considered as representative of current practice.…”

Section: Discussionmentioning

confidence: 99%

“…Mean VA at baseline ranged from 48.8 to 61.6 letters, excluding the studies by Shona et al, 32 Pushpoth et al, 26 and Nomura et al, 28 who reported VA outcomes for groups of patients stratified according to different …”

Section: Study Characteristicsmentioning

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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One‐Year Effectiveness Study of Intravitreous Ranibizumab in Wet (Neovascular) Age‐Related Macular Degeneration: A Meta‐Analysis

et al. 2018

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Measuring the benefit of 4 years of intravitreal ranibizumab treatment for neovascular age-related macular degeneration

Cited by 35 publications

References 12 publications

Metaanalysis of Real-World Outcomes of Intravitreal Ranibizumab for the Treatment of Neovascular Age-Related Macular Degeneration

Metaanalysis of Real-World Outcomes of Intravitreal Ranibizumab for the Treatment of Neovascular Age-Related Macular Degeneration

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

One‐Year Effectiveness Study of Intravitreous Ranibizumab in Wet (Neovascular) Age‐Related Macular Degeneration: A Meta‐Analysis

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