Summary of findings 2.
Ranibizumab versus aflibercept for diabetic macular oedema
| Ranibizumab versus aflibercept for diabetic macular oedema | ||||||
| Patient or population: people with diabetic macular oedema Settings: ophthalmology clinics Interventions: aflibercept, ranibizumab | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI), mixed evidence** | Certainty of the evidence (GRADE) | Reason for downgrading certainty of evidence | ||
| Assumed risk | Corresponding risk | |||||
| Aflibercept | Ranibizumab | |||||
| Gain 3+ lines of visual acuity at 1 year | 370 per 1000 | 278 per 1000 (222 to 348) | RR: 0.75 (0.60 to 0.94) | ⊕⊕⊕ moderate | −1 for imprecision as confidence intervals include both clinically important and clinically unimportant effects | |
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Visual acuity change at 1 year Measured on the logMAR scale, range −1.3 to 1.3. Higher values represent worse visual acuity. |
On average visual acuity improved by−0.23 logMAR units in the aflibercept group between the start of treatment and 1 year | Average change in visual acuity was 0.08 (0.05 to 0.11) logMAR units worse with ranibizumab compared with aflibercept |
⊕⊕⊕ moderate | −1 for imprecision as confidence intervals include both clinically important and clinically unimportant effects | ||
|
Central retinal thickness μm (CRT) change at 1 year The aim of treatment is to reduce central macular thickness so thinner is better. |
On average CRT changed by −181 μm in the aflibercept group between the start of treatment and 1 year (became thinner) | Average change in CRT was 39 (2 to 76) μm more (thicker) with ranibizumab compared with aflibercept |
⊕⊕ low | −1 for high heterogeneity in two direct comparisons and large predictive intervals −1 for imprecision |
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| Quality of life at 1 year | No data available. | |||||
| All serious systemic adverse events at 1 to 2 years | 345 per 1000 |
338 per 1000 (283 to 411) |
RR 0.98 (0.82 to 1.19) |
⊕⊕⊕⊕ high | ||
| Arterial thromboembolic events at 1 to 2 years | 60 per 1000 |
74 per 1000 (29 to 191) |
RR 1.24 (0.48 to 3.19) |
⊕ very low | Inconsistency between direct and indirect evidence (−1), and imprecise estimates (−2) | |
| Death at 1 to 2 years | 30 per 1000 |
35 per 1000 (11 to 108) |
RR 1.16 (0.38 to 3.58) |
⊕ very low | Inconsistency between direct and indirect evidence (−1), and imprecise estimates (−2) | |
| The assumed risk in the aflibercept group was estimated as the row sum of the events divided by the row sum of the participants (eyes) for dichotomous variables, and as the (unweighted) median change of visual acuity or central retina thickness. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ** The risk ratio was estimated from mixed (direct and indirect) comparisons. CI: Confidence interval; RR: Risk ratio. |
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| GRADE Working Group grades of evidence High‐certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate‐certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low‐certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low‐certainty: we are very uncertain about the estimate. | ||||||