An Open-Label Investigator Sponsored Trial to Investigate the Safety, Tolerability and Development of Subfoveal Fibrosis By Intravitreal Administration of Altering Regimens of Fovista and Anti-VEGF Therapy in Subjects With Neovascular Age-Related Macular Degeneration
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 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 2016-05-24, after 2014-02-28 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 2016-05-24. 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: subjectspresencetolerabilitysignificantcoronary
Phrases that lowered it: trialantimaculartherapyinvestigate -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 31.6% (raises risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Minimum age: 50 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 96.5% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Keywords listed: 0 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 1 (raises 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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- academic or other
- Sponsor's past trials
- 1 (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
- 46843 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9549 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 31.6% (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
- Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD NCT03805100 · started 2019 · scored riskier than 30% of active trials completed
- A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR) NCT00891735 · started 2009 · scored riskier than 49% of active trials completed
- Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration NCT04864834 · started 2021 · scored riskier than 74% of active trials completed
- A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial) NCT01025232 · started 2009 · scored riskier than 33% of active trials terminated
- Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) NCT05381948 · started 2022 · scored riskier than 47% 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.