Resolution of Angiographic Macular Leakage with Faricimab versus Aflibercept in Patients with Diabetic Macular Edema in YOSEMITE/RHINE
Bibliographic record
Abstract
To evaluate if dual angiopoietin-2 (Ang-2)/VEGF-A inhibition with faricimab resulted in greater macular leakage resolution versus aflibercept in patients with diabetic macular edema (DME). Post hoc analysis of macular leakage assessments prespecified in the YOSEMITE/RHINE (NCT03622580/NCT03622593) phase III trials. Adults with visual acuity loss due to center-involving DME. Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg according to a personalized treat-and-extend (T&E)-based regimen, or aflibercept 2.0 mg Q8W. This analysis included the first 16 weeks (head-to-head dosing period) when all patients received assigned study drug every 4 weeks (Q4W); patients were assessed 4 weeks after receiving 4 doses of assigned study drug Q4W. Macular leakage area on fluorescein angiography assessed by a reading center; proportion of patients with resolution of macular leakage (defined as macular leakage area 0–1 mm 2 ) and high macular leakage (defined as macular leakage area ≥10 mm 2 ) at baseline and week 16; and the proportion of faricimab T&E patients receiving Q16W dosing at week 52 among those with resolution of and high macular leakage at week 16. Among patients with macular leakage data available at baseline, there were 1216 patients in the pooled faricimab (Q8W + T&E) arms and 593 patients in the aflibercept arm. Baseline median macular leakage area was similar between the faricimab (24.6 mm 2 ) and aflibercept arms (25.6 mm 2 ). At week 16, median macular leakage area was 3.6 mm 2 with faricimab versus 7.6 mm 2 with aflibercept (nominal P < 0.0001). More faricimab-treated patients (28%) achieved resolution of macular leakage versus aflibercept at week 16 (15%; nominal P < 0.0001). In the faricimab T&E arm, 63% of patients with resolution of macular leakage and 45% of patients with high macular leakage at week 16 achieved Q16W dosing at week 52 (nominal P < 0.01). Faricimab demonstrated greater macular leakage resolution versus aflibercept during head-to-head dosing. These findings suggest that dual Ang-2/VEGF-A inhibition promotes vascular stability beyond VEGF inhibition alone, supporting faricimab’s potential to offer greater disease control and extend durability for patients with DME. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".