To Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus
Model scores of the 29,894 trials active now.
Model score 10% 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 14% of the time (741 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 2017-01-01, after 2011-03-31 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 2017-01-01. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: womenstudy eyediabetesmacularestrogen
Phrases that lowered it: malemmhgbevacizumabcomparative20 -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 21 (lowers risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports with a death: 16.4% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- 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
- 0 (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
- 3052 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1266 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.4% (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 Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema NCT01934556 · started 2013 · scored riskier than 29% of active trials completed
- A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema NCT06305416 · started 2024 · scored riskier than 17% of active trials completed
- Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE) NCT01552408 · started 2012 · scored riskier than 61% of active trials completed
- Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - a Sustained, Low Dose Dexamethasone Therapy NCT04576689 · started 2020 · scored riskier than 58% of active trials completed
- Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study NCT01077401 · started 2010 · scored riskier than 28% 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.