Gallivan (2023)
Neovascular age-related macular degeneration
Opthalmology • Ehr Data • Ireland
Study Metrics
Total Sample
4303
Treatment Group
1783
Control Group
2520
Covariates
4
PICO Comparisons
1
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Gallivan |
| Publication Year: | 2023 |
| DOI: | https://doi.org/10.3928/23258160-20221214-01 |
| Preprint: | No preprint |
Institution & Funding
| Institutions: | Verana Health (industry), American Academy of Ophthalmology (professional organization), Department of Ophthalmology, Byers Eye Institute at Stanford, Stanford University School of Medicine (academia) |
| Funding: | Declared: Public, private, NGO |
| Funding Institutions: | Supported in part by Verana Health, the National Institutes of Health Core Grants for Vision Research P30-EY026877 (TL), and unrestricted funds from Research to Prevent Blindness (TL). The funding organization, Verana Health, participated in the design of the study; conducting the study; data collec- tion; data management; data analysis; interpretation of the data; and preparation, review, or approval of the manuscript. The views expressed herein are those of the authors and do not necessarily reflect the policies or opinions of the American Academy of Ophthalmology. |
Study Context
| Disease: | Neovascular age-related macular degeneration |
| Disease Category: | Opthalmology |
| Data Type: | Electronic Health Records |
| Number of Data Sources: | 1 |
| Geography: | Ireland |
| Eligible Sample: | 90900.0 |
Analytical Methods
| Missing Data Method: | Complete case |
| Matching Method: | inverse-odds-of-sampling |
| Analysis Method: | ANOVA |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | VIEW 1 |
| Registration Number: | NCT00509795 |
| Target Trial DOI: | https://doi.org/10.1016/j.ophtha.2012.09.006, https://doi.org/10.1136/bjophthalmol-2019-315021 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Mean change in ETDRS BCVA letters
VIEW 1
MD
Efficacy
Population
Adult patients (≥50 years) with neovascular age-related macular degeneration (nAMD)
Intervention
RQ4: Monthly ranibizumab injection
Comparison
IAI 2Q8: Intravitreal aflibercept every 2 months after 3 initial monthly doses
Outcome
Mean change in ETDRS BCVA letters
RCT Result
0.50
95% CI: [-1.69, 2.69]
vs
TTE Result
-1.30
95% CI: [-4.91, 2.31]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
Transparency Indicators
Protocol Registration
Available
Data Sharing
Not Available
Code Sharing
Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.
Conflicts & Funding
| Conflicts of Interest: | Declared: Financial |
| COI Institutions: | Verana Health, Roche/Genentech, Protagonist Therapeutics, Graybug, Apellis, Regeneron, Astellas, Nanoscope |
| Funding Source: | Declared: Public, private, NGO |
| Funding Institutions: | Supported in part by Verana Health, the National Institutes of Health Core Grants for Vision Research P30-EY026877 (TL), and unrestricted funds from Research to Prevent Blindness (TL). The funding organization, Verana Health, participated in the design of the study; conducting the study; data collec- tion; data management; data analysis; interpretation of the data; and preparation, review, or approval of the manuscript. The views expressed herein are those of the authors and do not necessarily reflect the policies or opinions of the American Academy of Ophthalmology. |