Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
Model scores of the 29,894 trials active now.
Model score 16% 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 22% of the time (49 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-10-01, after 2020-12-10 start.
Reason given by the sponsor: “safety”
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 2022-10-01. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: diabeticmgeyediabetestype
Phrases that lowered it: diseasesinjectionthe studyolder65 -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Design: sequential (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
-
Keywords listed: 11 (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Responsible party: sponsor (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
- 1/2 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 11 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, metabolic, endocrine
- Drugs matched to FDA substances
- none matched
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
- A Single Ascending Dose Cohort Study of AG-73305 in DME Patients NCT05301751 · started 2022 · scored riskier than 29% of active trials completed
- Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration NCT04746963 · started 2021 · scored riskier than 67% of active trials terminated
- Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema NCT05324592 · started 2021 · scored riskier than 19% of active trials completed
- A Study of ASKG712 in Patients With Diabetic Macular Edema NCT05940428 · started 2023 · scored riskier than 14% of active trials completed
- A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD) NCT05919693 · started 2023 · scored riskier than 50% 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.