Open-label, Multli-center, Phase 1b/2a Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients With Macular Edema
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (257 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2016-06-30, after 2015-07-31 start.
Reason given by the sponsor: “enrollment”
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 2016-06-30. 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
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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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: macularedemasecondaryage 18previous
Phrases that lowered it: efficacyto evaluateevaluate thesafetydexamethasone -
Phase: 1/2 (raises risk) · Design
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 25.0% (raises risk) · Drug's FDA history
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Maximum age: 90 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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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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Responsible party: sponsor (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 90 (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
- 6 (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
- 57672 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17186 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dexamethasone
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
- OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) NCT02571556 · started 2015 · scored riskier than 11% of active trials completed
- Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis NCT01505088 · started 2011 · scored riskier than 24% of active trials completed
- Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis NCT02517619 · started 2016 · scored riskier than 11% of active trials completed
- Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO) NCT01660802 · started 2012 · scored riskier than 29% of active trials completed
- Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL NCT01602068 · started 2012 · scored riskier than 16% 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.