Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 16% of the time (370 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-06-18, after 2020-06-29 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 2024-06-18. 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
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: eyediabetickeyprotocol definedpatients
Phrases that lowered it: participantthe effecteffect ofvisitevaluate the -
Sponsor's past termination rate: 8.4% (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 35 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 38.3% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Phase: 2/3 (raises risk) · Design
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Drug's FAERS reports marked serious: 90.1% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Sponsor's past trials: 119 (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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
- 2/3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (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
- 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
- 119 (typical: 32)
- Sponsor's past termination rate
- 8.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 35 (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
- metabolic, immunology, endocrine
- 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 Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME) NCT02818998 · started 2016 · scored riskier than 22% of active trials completed
- Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration NCT04126317 · started 2019 · scored riskier than 60% of active trials completed
- Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema NCT05324592 · started 2021 · scored riskier than 19% of active trials completed
- A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema NCT03397264 · started 2018 · scored riskier than 18% of active trials completed
- DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact NCT00789477 · started 2008 · scored riskier than 10% 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.