HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration

NCT01189019 on ClinicalTrials.gov Phase 2 Anne Fung MD (academic or other) Started 2010-08-31 Terminated

Riskier than 22% of active trials

Model scores of the 29,894 trials active now.

Model score 12% 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 16% of the time (1,198 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

Terminated on 2013-03-31, after 2010-08-31 start.

Reason given by the sponsor: “other”

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 2013-03-31. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: subjectdiabeticpregnancyinabilityage
Phrases that lowered it: eyesubjects whopatients whoefficacy andand safety
Phase: 2 (raises risk) · Design
Maximum age: 99 (lowers risk) · Who can join
Responsible party: sponsor investigator (raises risk) · Design
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
Minimum age: 50 (raises risk) · Who can join
Has a data monitoring committee: Yes (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 89.4% (lowers risk) · Drug's FDA history
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: 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: sponsor investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 5 (typical: 1)

Who can join

Minimum age: 50 (typical: 18)
Maximum age: 99 (typical: 71)
Sex: all
Accepts healthy volunteers: No (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: 2301 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 939 (typical: 412.5)
Drug's FAERS reports marked serious: 89.4% (typical: 85.6%)
Drug's FAERS reports with a death: 13.8% (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 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
Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments NCT00749021 · started 2008 · scored riskier than 36% 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
Prophylactic Ranibizumab for Exudative Age-Related Macular Degeneration NCT02302989 · started 2015 · scored riskier than 35% of active trials completed
Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration NCT03038880 · started 2017 · scored riskier than 41% 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.