ArticleOphthalmology science
Population Pharmacokinetics of Pegcetacoplan in Patients with Geographic Atrophy or Neovascular Age-related Macular Degeneration.
Article in Ophthalmology science. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Pharmacokinetic/pharmacodynamic analysis of geographic atrophy lesion area in patients receiving pegcetacoplan treatment or sham.CPT: pharmacometrics & systems pharmacology · 2025Trial
- Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products.The AAPS journal · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: To develop a population pharmacokinetic (PK) model to characterize serum pegcetacoplan concentration-time data after intravitreal administration in patients with geographic atrophy (GA) or neovascular age-related macular degeneration (nAMD). Design: Pharmacokinetic modeling. Participants: Two hundred sixty-one patients with GA or nAMD enrolled in 4 clinical studies of pegcetacoplan. Methods: Serum concentration data were pooled from 4 clinical studies. Pegcetacoplan dosing included single intravitreal injections of 4, 10, and 20 mg and multiple intravitreal injections of 15 mg monthly or every other month. Considering a high proportion of samples were below the limit of quantification (BLQ) in serum following intravitreal administration, the M3 method of likelihood-based handling of data BLQ was employed in NONMEM (version 7.4). Covariate model development was performed using stepwise forward (α = 0.05) and backward (α = 0.001) selection. Predicted PK parameters and exposure metrics were generated via simulation in serum and vitreous humor. Main Outcome Measures: Pharmacokinetic parameters. Results: Intravitreal pegcetacoplan displayed absorption-limited (i.e., "flip-flop") kinetics with median empirical Bayes estimated pegcetacoplan absorption and elimination half-lives of 13.1 days and 4.51 days, respectively. Vitreous exposure was predicted to be >1300-fold higher than serum exposure, with maximum concentrations in serum below the threshold required to elicit systemic pharmacodynamic effects. Drug accumulation from first dose to steady state was predicted to be minimal in serum (mean accumulation ratio = 1.50 with monthly dosing, 1.10 with every-other-month dosing) and vitreous humor (mean accumulation ratio = 1.30 with monthly dosing, 1.10 with every-other-month dosing). Age, sex, and baseline C3 level were identified as significant ( Conclusions: This population PK model adequately described the serum concentration-time profile of pegcetacoplan after intravitreal administration in adults with GA or nAMD. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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