Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema
Model scores of the 29,894 trials active now.
Model score 11% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-01-25, after 2021-02-26 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 2022-01-25. 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
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: glaucomatype diabetesdiabeticwith typeeye
Phrases that lowered it: macularpharmacokineticsstudy eyesingle dosepressure -
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 34.6% (raises risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 85.0% (lowers risk) · Drug's FDA history
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 (typical: 2)
- Number of arms
- 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
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 21887 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3073 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 34.6% (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
- Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease NCT04429503 · started 2020 · scored riskier than 43% of active trials completed
- 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
- 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
- A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) NCT04611152 · started 2020 · scored riskier than 32% of active trials terminated
- A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) NCT04603937 · started 2020 · scored riskier than 32% of active trials terminated
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.