Evaluating of the Safety, Pharmacokinetics and Pharmacodynamics of QL1205 and Lucentis® in Patients With Wet AMD
Model scores of the 29,894 trials active now.
Model score 11% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-04-02, after 2017-12-20 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 2019-04-02. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Minimum age: 50 (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: eyediabeticthe subjectcorrectedocular
Phrases that lowered it: pharmacokinetics20groupsafetyrandomized -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Blinding: triple (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 22.4% (raises risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 90.5% (lowers 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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- 80 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 17430 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2636 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- 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
- A Study to Compare QL1207 to Eylea® in Subjects With Wet Age-related Macular Degeneration (wAMD) NCT05345236 · started 2019 · scored riskier than 39% of active trials completed
- ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients NCT01304693 · started 2010 · scored riskier than 85% of active trials completed
- Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD NCT04690556 · started 2020 · scored riskier than 41% of active trials completed
- A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration NCT04857177 · started 2018 · scored riskier than 34% of active trials completed
- Efficacy and Safety of RTH258 Versus Aflibercept - Study 1 NCT02307682 · started 2014 · scored riskier than 39% 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.