A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (220 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2014-12-31, after 2012-11-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2014-12-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: eyesafety andassess theto assessthe safety
Phrases that lowered it: patientsuncontrolledstudy eyemacularpatient -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 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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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 24.3% (raises risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 61531 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (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
- 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
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 61531 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 15914 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- dexamethasone, dobesilate, ketorolac, prednisolone
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
- The Effect of Intravitreal Ozurdex on DME After Cataract Surgery NCT01748487 · started 2012 · scored riskier than 23% of active trials completed
- Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery NCT01284478 · started 2011 · scored riskier than 12% of active trials completed
- Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema NCT01571232 · started 2012 · scored riskier than 19% of active trials completed
- Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery NCT01988246 · started 2013 · scored riskier than 34% of active trials completed
- Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema NCT05697809 · started 2023 · scored riskier than 32% 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.