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

Arm Details

1. Number of participants in this study
Intravitreal aflibercept 0.5 mg every 4 weeks:
Multiple Choice
Number of participants/eyes randomized...
Number of participants/eyes lost follow-up...
Number of participants/eyes in full analysis...
Number of participants/eyes in safety analysis...

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

Baselines

N/A

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:
Single Choice
Yes, precision measures are numeric and can be extracted for meta-analysis
Yes, but precision measures cannot be extracted accurately (e.g., presented in a difficult-to-read graph)
No
Can't tell
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
Single Choice
Yes
No
One or more time points after baseline and ≤1 year
Single Choice
Yes
No
One or more time points after baseline >1 year and ≤2 years
Single Choice
Yes
No
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:

Quality

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

Suggested Arms

NameDescription
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

Please see downloadable data for more

Suggested Outcomes

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

Please see downloadable data for more