Extraction form for project: Aflibercept for neovascular age-related macular degeneration (2016)

Arms

Arm NameArm Description
Intravitreal aflibercept 0.5 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 8 weeksintravitreal aflibercept 2.0 mg every 8 weeks after 3 initial doses at weeks 0, 4, and 8 (to maintain masking, sham injections were given at the interim 4-week visits after week 8)
Intravitreal ranibizumab 0.5 mg every 4 weeks

Arm Details

1. Number of participants in this study
Intravitreal aflibercept 0.5 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 8 weeks
Intravitreal ranibizumab 0.5 mg every 4 weeks

Outcomes

TypeDomainSpecific MeasurementPopulationsTimepoints
ContinuousProportion of patients who lost >15 letters of BCVA at 1 year and 2 years
  • All Participants
  • 2 (years)
  • 1 (years)
ContinuousMean change in BCVA at 1 yearBCVA: best-corrected visual acuity
  • All Participants
  • 1 (years)
ContinuousProportion gaining greater than or equal to 15 letters
  • All Participants
  • 2 (years)
  • 1 (years)
ContinuousQuality-of-life improvementChange in total National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25) score
  • All Participants
  • 1 (years)
ContinuousChange in CNV area on fluorescein angiographyCNV: choroidal neovascularization
  • All Participants
  • 1 (years)
ContinuousRetinal thicknessRetinal thickness as assessed by Optical Coherence Tomography (OCT)
  • All Participants
  • 1 (years)
ContinuousAbsence of fluid eventsPersistent fluid as assessed by Optical Coherence Tomography (OCT)
  • All Participants
  • 2 (years)
ContinuousMean number of intravitreal injections
  • All Participants
  • 2 (years)
ContinuousMean change in BCVA at 2 yearsBCVA: best-corrected visual acuity
  • All Participants
  • 2 (years)

Design

1. Page
2. Study design
3. Number randomly assigned
4. Exclusions after randomization
5. Losses to follow-up
6. Number analyzed
7. Unit of analysis
8. Power calculation
9. Country
10. Mean age (range not reported)
11. Gender
12. Inclusion criteria
13. Exclusion criteria
14. Equivalence of baseline characteristics
15. Intervention 1
16. Intervention 2
17. Intervention 3
18. Intervention 4
19. Length of follow-up
20. Primary outcome, as defined in study reports
21. Secondary outcomes, as defined in study reports
22. Intervals at which outcomes assessed
23. Type of study reports
24. Funding sources
25. Disclosures of interest
26. Study period
27. Subgroup analyses
28. Full analysis - 38 total participants
29. Safety analysis - 36 total participants
30. Random sequence generation (selection bias):Authors' judgement
31. Random sequence generation (selection bias):Support for judgement
32. Allocation concealment (selection bias):Authors' judgement
33. Allocation concealment (selection bias):Support for judgement
34. Masking of participants and personnel (performance bias):Authors' judgement
35. Masking of participants and personnel (performance bias):Support for judgement
36. Masking of outcome assessment (detection bias):Authors' judgement
37. Masking of outcome assessment (detection bias):Support for judgement
38. Incomplete outcome data (attrition bias):Authors' judgement
39. Incomplete outcome data (attrition bias):Support for judgement
40. Selective reporting (reporting bias):Authors' judgement
41. Selective reporting (reporting bias):Support for judgement
42. Other bias:Authors' judgement
43. Other bias:Support for judgement

Outcome Details

1. Were data available?
Example of selecting "No": (1) precision measures were not reported any where in the text or graphs; (2) reported only statistical significance without providing the exact P value.
Proportion of patients who lost >15 letters of BCVA at 1 year and 2 years
Mean change in BCVA at 1 year
Proportion gaining greater than or equal to 15 letters
Quality-of-life improvement
Change in CNV area on fluorescein angiography
Retinal thickness
Absence of fluid events
Mean number of intravitreal injections
Mean change in BCVA at 2 years
2. Time points for which data were reported
Only specify other time points if >2 years.
Proportion of patients who lost >15 letters of BCVA at 1 year and 2 years
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Mean change in BCVA at 1 year
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Proportion gaining greater than or equal to 15 letters
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Quality-of-life improvement
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Change in CNV area on fluorescein angiography
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Retinal thickness
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Absence of fluid events
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Mean number of intravitreal injections
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
Mean change in BCVA at 2 years
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Other (please specify):
3. Any other relevant information about how data were collected or reported?
Type "None" if no additional comments.
Proportion of patients who lost >15 letters of BCVA at 1 year and 2 years
Mean change in BCVA at 1 year
Proportion gaining greater than or equal to 15 letters
Quality-of-life improvement
Change in CNV area on fluorescein angiography
Retinal thickness
Absence of fluid events
Mean number of intravitreal injections
Mean change in BCVA at 2 years

Baselines

N/A

Results

Continuous


Proportion of patients who lost >15 letters of BCVA at 1 year and 2 years

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
2 (years)
N Analyzed
Unit
1 (years)
N Analyzed
Unit
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Mean change in BCVA at 1 year (BCVA: best-corrected visual acuity)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
1 (years)
N Analyzed
Mean
SD
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Proportion gaining greater than or equal to 15 letters

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
2 (years)
N Analyzed
Unit
Mean
1 (years)
N Analyzed
Unit
Mean
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Quality-of-life improvement (Change in total National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25) score)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
1 (years)
N Analyzed
Mean
SD
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Change in CNV area on fluorescein angiography (CNV: choroidal neovascularization)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
1 (years)
N Analyzed
Mean
SD
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Retinal thickness (Retinal thickness as assessed by Optical Coherence Tomography (OCT))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
1 (years)
N Analyzed
Mean
SD
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Absence of fluid events (Persistent fluid as assessed by Optical Coherence Tomography (OCT))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
2 (years)
N Analyzed
Unit
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Mean number of intravitreal injections

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
2 (years)
N Analyzed
Unit
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Mean change in BCVA at 2 years (BCVA: best-corrected visual acuity)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks
2 (years)
N Analyzed
Mean
Within Arm ComparisonsNet Comparisons
Intravitreal aflibercept 0.5 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 4 weeksIntravitreal aflibercept 2.0 mg every 8 weeksIntravitreal ranibizumab 0.5 mg every 4 weeks

Quality

1. Adjust Quality Rating (for Key Questions: 1)
Quality Guideline Used:
Select Current Overall Rating:
Notes on this Rating: