A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 1% 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-06-11. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 1/2 (raises risk) · Design
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: oculartherapydosephaseescalation
  Phrases that lowered it: participantparticipantsopenlabelassessment
• Number of arms: 5 (lowers risk) · Design
• Has a data monitoring committee: not given (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: 31.3% (raises risk) · Drug's FDA history
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
• Maximum age: not given (raises risk) · Who can join
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: 92.7% (lowers risk) · Drug's FDA history
• Responsible party: sponsor (raises risk) · Design
• 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.

• 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
• Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema NCT05324592 · started 2021 · scored riskier than 19% 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

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.