| Pegaptanib compared with control for neovascular age-related macular degeneration | ||||||
|---|---|---|---|---|---|---|
| Participant or population: people with neovascular age-related macular degeneration Settings: clinical centers Intervention: intravitreal injections of pegaptanib Comparison: sham injections | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Pegaptanib | |||||
| Gain of 15 letters or more visual acuity at one year | 20 per 1000 | 57 per 1000 (25 to 132) | RR 2.83 (1.23 to 6.52) | 1186 (1) | ⊕⊕⊕⊕ high |
|
| Loss of fewer than 15 letters visual acuity at one year | 554 per 1000 | 687 per 1000 (615 to 770) | RR 1.24 (1.11 to 1.39) | 1186 (1) | ⊕⊕⊕⊕ high |
|
| Mean change in visual acuity at one year (number of letters) | The mean change in the control group was a loss of 15 letters | The mean change in visual acuity in the pegaptanib groups was on average 6.72 more letters gained (95% CI 4.43 letters to 9.01 letters) | MD 6.72 (4.43 to 9.01) | 1186 (1) | ⊕⊕⊕⊕ high |
|
| Reduction in central retinal thickness at one year | - | - | - | - | - | Outcome not assessed by this trial. |
| No problems in quality of life domains at one year | - | - | - | - | - | Treatment with pegaptanib was associated with better scores on the NEI-VFQ questionnaire, specifically for distance vision and role limitation domains; however, standard deviations for scores were not reported |
| Serious systemic adverse events at one year | 151 per 1000 with at least one serious systemic adverse event | 189 per 1000 (140 to 257) | RR 1.25 (0.93 to 1.70) | 1190 (1) | ⊕⊕⊕○ moderate1 |
|
| Serious ocular adverse events at one year | 7 per 1000 with any eye disorder | 26 per 1000 (6 to 109) | RR 3.84 (0.91 to 16.20) | 1190 (1) | ⊕⊕⊕○ moderate1 |
|
*
The basis for the assumed risk is estimated by the proportion with the event in the control group. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio; MD: mean difference
| The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: 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 quality: We are very uncertain about the estimate. |
1
Adverse events downgraded to moderate quality as the numbers of events were small (<1%) for many specific adverse events