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NCT04424290 · ClinicalTrials.gov registry record · Phase 1

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia

A Phase 1 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target

NCT04424290 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 45 participants.

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The verdict

NCT04424290, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target

Study Summary

This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study. The laser treatment is called panretinal photocoagulation. The purpose of the study is to find out how well different doses of a medicine called BI 764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first part, participants get different doses of BI 764524 only once. Participants are in the first part for about 5 months and visit the study site about 8 times. In the second part, participants are put into different groups by chance. Some participants get BI 764524 injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. For the second part, participants are in the study for about 7 months. During this time, they visit the study site about 7 times. In this study, BI 764524 is given to humans for the first time. The doctors compare how well people tolerate the BI 764524 injections and the sham injections. The doctors also regularly check the general health of the participants.

Interventions

  • DRUG BI 764524
  • DRUG Sham control of BI 764524

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2020-06-12
Est. Completion 2023-04-28
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT04424290

The ClinicalTrials.gov registry entry for NCT04424290 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which BI 764524 is the first listed.

NCT04424290 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04424290 about?

NCT04424290 is a clinical study titled "HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia". This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study. The laser treatment is called panretinal photocoagulation. The purpose of the st...

What is the current status of trial NCT04424290?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2020-06-12. Estimated completion is 2023-04-28.

What interventions are being tested in trial NCT04424290?

The interventions under investigation include: BI 764524 (DRUG), Sham control of BI 764524 (DRUG).

Who is sponsoring clinical trial NCT04424290?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.