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NCT04002310 · ClinicalTrials.gov registry record · Phase 1
A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT04002310: Clinical Trial Phase 1 study, sponsored by Boehringer Ingelheim.
NCT04002310 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04002310, a Phase 1 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a study in adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated. The participants are in the study for about 4 months. During this time, they visit the study site about 10 times. Participants receive 1 injection of BI 754132 directly into one of the eyes affected by geographic atrophy. In this study, BI 754132 is given to humans for the first time. The doctors compare how well participants tolerate the different doses of BI 754132. The doctors also regularly check the general health of the participants.
Primary Outcome
SRD part: Number of patients with ocular or systemic DLEs from drug administration. Systemic DLEs were defined as drug-related adverse events (AEs), as defined by the investigator, of moderate or severe intensity on the Common terminology criteria for adverse events (CTCAE) scale, and included diarrhea, cough, or patient-reported paraesthesia, dysgeusia, taste abnormality, taste disorder, or hyposmia. Single rising dose (SRD) part.
Interventions
- DRUG BI 754132
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-07-26 |
| Est. Completion | 2022-08-09 |
| Phase | Phase 1 |
Why NCT04002310 stopped before completion
NCT04002310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which BI 754132 is the first listed.
NCT04002310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04002310 about?
NCT04002310 is a clinical study titled "A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy". This is a study in adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated. The participants are in the study for about 4 months. During this time, they visit the study site ab...
What is the current status of trial NCT04002310?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-07-26. Estimated completion is 2022-08-09.
What interventions are being tested in trial NCT04002310?
The interventions under investigation include: BI 754132 (DRUG).
Who is sponsoring clinical trial NCT04002310?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04002310's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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