Safety Study of iCo-007 Intravitreal Injection to Treat Diabetic Macular Edema

Model scores of the 29,894 trials active now.

Model score 12% 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 7% of the time (318 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2010-06-30. 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.

• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectstolerabilityocularthe safetyeye
  Phrases that lowered it: moderateopen labelmaculartransaminaseintravitreal
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: single group (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Number of arms: 4 (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Maximum age: not given (raises risk) · Who can join
• Sponsor type: industry (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.

• A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study) NCT01565148 · started 2012 · scored riskier than 23% of active trials terminated
• A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema NCT05489718 · started 2022 · scored riskier than 18% of active trials completed
• Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab NCT01292798 · started 2011 · scored riskier than 34% of active trials completed
• Evaluation of RC28-E Injection in Diabetic Macular Edema NCT04782115 · started 2021 · scored riskier than 24% of active trials completed
• Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema NCT01042678 · started 2010 · scored riskier than 40% 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.