A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration

NCT01749891 on ClinicalTrials.gov Phase 1/2 Allegro Ophthalmics, LLC (industry) Started 2012-03-31 Completed

Riskier than 32% of active trials

Model scores of the 29,894 trials active now.

Model score 13% 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 16% of the time (257 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 2013-06-07, after 2012-03-31 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 2013-06-07. 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
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Phase: 1/2 (raises risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Minimum age: 50 (raises risk) · Who can join
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
Number of arms: 3 (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Collaborators: 0 (raises risk) · Design
Sponsor type: industry (lowers 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: 1/2 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 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: 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: 0 (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

RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration NCT03633084 · started 2018 · scored riskier than 38% of active trials completed
A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD) NCT05919693 · started 2023 · scored riskier than 50% of active trials completed
Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration NCT02398500 · started 2015 · scored riskier than 52% of active trials terminated
Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration NCT01086761 · started 2010 · scored riskier than 48% of active trials terminated
Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration NCT05587062 · started 2019 · scored riskier than 19% 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.