Summary of findings for the main comparison. Summary of findings: intravitreal anti‐VEGF plus intravitreal steroid versus intravitreal anti‐VEGF for diabetic macular oedema.
| Intravitreal anti‐VEGF plus intravitreal steroid versus intravitreal anti‐VEGF for diabetic macular oedema | ||||||
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Patient or population: adults with centre‐involving diabetic macular oedema Settings: eye care clinic Intervention: intravitreal anti‐VEGF plus intravitreal steroid (anti‐VEGF/steroid) Comparison: intravitreal anti‐VEGF | ||||||
| Outcomes | Illustrative comparative risks* | Relative effect (95% CI) | No. of eyes (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Anti‐VEGF alone | Anti‐VEGF/steroid | |||||
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Mean change in visual acuity at 1 year (number of letters read on logMAR chart) |
The mean visual acuity gain at 1 year ranged from 4.9 to 10.5 letters in the anti‐VEGF alone groups | The mean number of letters read was on average 2.29 fewer in the anti‐VEGF/steroid group (95% CI −6.03 to 1.45) | — | 188 (3) |
Lowa | — |
| Mean change in central macular thickness at 1 year | The mean reduction in central macular thickness at 1 year ranged from −30 μm to −179 μm in the anti‐VEGF alone groups | The mean reduction in central macular thickness was on average 0.20 μm greater in the anti‐VEGF/steroid groups (95% CI −37.14 to 37.53) | — | 188 (3) |
Lowa | — |
| Significant intraocular inflammation at follow‐up (from 6 months onwards) | 6 per 1000 | 3 per 1000 (0 to 30 per 1000) |
Peto OR 0.53 (0.05 to 5.08) | 635 (8) |
Very lowb | Only 3 events |
| Development of cataract at follow‐up (from 6 months onwards) | 3 per 1000 | 22 per 1000 (9 to 56 per 1000) |
Peto OR 7.49 (2.87 to 19.60) | 635 (8) |
Moderatec | NB: significant cataract progression may occur in the second year of intravitreal steroid use. |
| Raised intraocular pressure at follow‐up (from 6 months onwards) | 6 per 1000 | 47 per 1000 (27 to 79 per 1000) |
Peto OR 8.13 (4.67 to 14.16) | 635 (8) |
Moderatec | 1 participant needed glaucoma surgery in the anti‐VEGF/steroid group.This outcome occurred only in 1 study. The threshold for glaucoma drainage surgery was not specified. |
| Systemic adverse events at follow‐up (from 6 months onwards) | 400 per 1000 | 468 per 1000 (289 to 1000) |
Peto OR 1.32 (95% CI 0.61 to 2.86) |
103 (1) |
Lowd | |
| Quality of life at follow‐up (from 6 months onwards) | Not reported | |||||
| *The assumed risk is the control group risk across studies. The corresponding risk is based on the assumed risk in the comparison group and the relative effect of the intervention. CI: confidence interval; RR: risk ratio; MD: mean difference; SD: standard deviation. | ||||||
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GRADE Working Group grades of evidence High‐certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate‐certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low‐certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low‐certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded one level because of risk of bias and by one level because of imprecision. bDowngraded one level because of risk of bias, and two levels for imprecision as there were very few events.
cDowngraded one level because of risk of bias
dDowngraded two levels for imprecision