A Study of Implantation of Retinal Pigment Epithelium in Subjects with Acute Wet Age Related Macular Degeneration

NCT01691261 on ClinicalTrials.gov Phase 1 Moorfields Eye Hospital NHS Foundation Trust (academic or other) Started 2021-10-14 Completed

Riskier than 60% of active trials

Model scores of the 29,894 trials active now.

Model score 18% 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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-06-24, after 2021-10-14 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 2024-06-24. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: pfmaculareyeoculardegeneration
Phrases that lowered it: open labelfemalesas determineddetermined byaged
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Minimum age: 60 (raises risk) · Who can join
Design: single group (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Number of arms: 1 (raises risk) · Design
Collaborators: 1 (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: 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: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 60 (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: 21 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 2 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: none matched

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 PhaseI/IIa Study to Determine the Safety and Tolerability of MA09-hRPE Cells in Patients With Advanced Dry AMD NCT01674829 · started 2012 · scored riskier than 23% of active trials terminated
Safety and Tolerability of MA09-hRPE Cells in Patients With Stargardt's Macular Dystrophy(SMD) NCT01625559 · started 2012 · scored riskier than 24% of active trials completed
Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration NCT01086761 · started 2010 · scored riskier than 48% of active trials terminated
Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients With Stargardt's Macular Dystrophy (SMD) NCT01469832 · started 2011 · scored riskier than 56% of active trials completed
HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration NCT01189019 · started 2010 · scored riskier than 22% 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.