A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

NCT02387957 on ClinicalTrials.gov Phase 2 Ophthotech Corporation (industry) Started 2016-04-26 Terminated

Riskier than 66% of active trials

Model scores of the 29,894 trials active now.

Model score 19% 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 13% of the time (1,304 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2017-01-31, after 2016-04-26 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 2017-01-31. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectsamdmacularstudy eyechoroidal
Phrases that lowered it: safety ofagedto evaluateevaluate theconditions
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 50 (raises risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 30.2% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Responsible party: sponsor (raises risk) · Design
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.

The trial

Design

Phase: 2
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 6 (typical: 1)

Who can join

Minimum age: 50 (typical: 18)
Maximum age: not given (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: 3 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 63771 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8231 (typical: 412.5)
Drug's FAERS reports marked serious: 96.1% (typical: 85.6%)
Drug's FAERS reports with a death: 30.2% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: aflibercept, bevacizumab, ranibizumab

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

Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD NCT02214628 · started 2014 · scored riskier than 41% of active trials terminated
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy NCT01940887 · started 2014 · scored riskier than 92% of active trials terminated
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy NCT01944839 · started 2013 · scored riskier than 84% of active trials terminated
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy NCT01940900 · started 2013 · scored riskier than 84% of active trials terminated
Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD NCT02543229 · started 2015 · scored riskier than 24% 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.