PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (283 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-12-31, after 2020-11-01 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 2022-12-31. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Design: single group (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports with a death: 5.5% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 94.5% (raises risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: equal toinfantsor equalpretermprematurity
Phrases that lowered it: patientsiiefficacyevaluate theto evaluate -
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Maximum age: 0.33 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 3 (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
- 1/2 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 0.33 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 0 (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
- 55 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ripasudil
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
- RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity NCT02375971 · started 2015 · scored riskier than 74% of active trials completed
- Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study) NCT02344225 · started 2015 · scored riskier than 94% of active trials completed
- Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity NCT02134457 · started 2014 · scored riskier than 28% of active trials completed
- Safety and Efficacy of Propranolol in Newborns With Retinopathy of Prematurity NCT01079715 · started 2010 · scored riskier than 76% of active trials completed
- Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study NCT01238471 · started 2010 · scored riskier than 89% 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.