A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]

NCT04270747 on ClinicalTrials.gov Phase 3 Amgen (industry) Started 2020-06-22 Completed

Riskier than 64% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2023-01-30, after 2020-06-22 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-01-30. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectsrandomizationpresence ofocularsubject
Phrases that lowered it: study eyeinjectionwithin weeksand safetymacular
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 38.3% (raises risk) · Drug's FDA history
Minimum age: 50 (raises risk) · Who can join
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 69 (lowers risk) · Sponsor's track record
Sponsor's past trials: 575 (raises risk) · Sponsor's track record
Blinding: triple (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Collaborators: 1 (raises risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 50 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 575 (typical: 32)
Sponsor's past termination rate: 11.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 69 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 19303 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2947 (typical: 412.5)
Drug's FAERS reports marked serious: 90.1% (typical: 85.6%)
Drug's FAERS reports with a death: 38.3% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: aflibercept

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration NCT05587062 · started 2019 · scored riskier than 19% of active trials completed
A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD) NCT04480463 · started 2020 · scored riskier than 44% of active trials completed
Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD) NCT02914639 · started 2016 · scored riskier than 57% of active trials completed
A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD) NCT04450329 · started 2020 · scored riskier than 46% of active trials completed
Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration NCT04864834 · started 2021 · scored riskier than 74% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.