Brolucizumab for Diabetic Macular Edema in Participants with/without prior Anti-VEGF Exposure
Bibliographic record
Abstract
OBJECTIVE: To evaluate visual and anatomical outcomes of brolucizumab 6 mg versus aflibercept 2 mg in subgroups of participants with/without prior anti-VEGF treatment for diabetic macular edema in the KINGFISHER study. DESIGN: Post hoc analysis of the KINGFISHER study. PARTICIPANTS: Of 517 participants randomized, 370 (71.6%) were treatment-naive (brolucizumab 6 mg [n = 251]; aflibercept 2 mg [n = 119]), and 147 (28.4%) prior-treated (brolucizumab 6 mg [n = 95]; aflibercept 2 mg [n = 52]) participants were included. METHODS: Visual and anatomical outcomes were analyzed, and descriptive statistics were provided for outcome measures. MAIN OUTCOME MEASURES: Assessment of the changes (least squares mean [standard error]) from baseline to week 52 in best-corrected visual acuity (BCVA) and central subfield thickness, proportion of study eyes with absence of both subretinal fluid and intraretinal fluid at week 52, proportion of participants with ≥2-step improvement from baseline to week 52 in Diabetic Retinopathy Severity Scale (DRSS) score, and incidence of intraocular inflammation (IOI)-related adverse events. RESULTS: The mean BCVA changes from baseline to week 52 in the prior-treated and treatment-naive subgroups were brolucizumab 6 mg (+11.0 [1.00] letters) versus aflibercept 2 mg (+8.6 [1.35] letters) and brolucizumab 6 mg (+12.6 [0.58] letters) versus aflibercept 2 mg (+12.2 [0.85] letters), respectively. Central subfield thickness reductions from baseline to week 52 in the prior-treated subgroup were brolucizumab 6 mg (-255.3 [11.27] μm) versus aflibercept 2 mg (-189.6 [15.32] μm) and in the treatment-naive subgroup were brolucizumab 6 mg (-231.4 [5.65] μm) versus aflibercept 2 mg (-199.0 [8.21] μm). A higher proportion of participants treated with brolucizumab 6 mg had a fluid-free macula at week 52 in both subgroups. The proportion of participants with ≥2-step improvement from baseline in DRSS at week 52 was comparable between the 2 subgroups and trended higher in the brolucizumab 6 mg arm. The incidence of IOI was brolucizumab 6 mg (4.2%) versus aflibercept 2 mg (5.8%) in the prior-treated subgroup and was brolucizumab 6 mg (4.0%) versus aflibercept 2 mg (1.7%) in the treatment-naive subgroup. CONCLUSIONS: These results demonstrate the effectiveness of brolucizumab 6 mg irrespective of the prior treatment status of the participants. FINANCIAL DISCLOSURE(S): 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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".