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BI 764524 for Diabetic Retinopathy (HORNBILL Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 weeks
Awards & highlights

HORNBILL Trial Summary

This trial is investigating the safety and effectiveness of a new medication for people with diabetic retinopathy with diabetic macular ischemia.

Eligible Conditions
  • Diabetic Retinopathy

HORNBILL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Multiple dosing (MD) part: Number of patients with drug related adverse events (AEs) from drug administration till end of study (EOS)
Single rising dose (SRD) part: Number of participants with dose limiting events
Secondary outcome measures
MD part: Change from baseline of BCVA at Visit 4
MD part: Change from baseline of BCVA at Visit 5
MD part: Change from baseline of BCVA at Visit 6
+12 more

HORNBILL Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: SRD part: BI 764524Experimental Treatment1 Intervention
SRD part: BI 764524
Group II: MRD part: BI 764524Experimental Treatment1 Intervention
MRD part: BI 764524
Group III: MRD part: Sham control of BI 764524Placebo Group1 Intervention
MRD part: Sham control of BI 764524
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 764524
2020
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,247 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
360 Patients Enrolled for Diabetic Retinopathy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many health care centers are conducting research involving this program in Canada?

"Emerson Clinical Research Institute in Falls Church, Austin Research Center for Retina, PLLC in Austin and the Retina Research Institute of Texas are amongst 4 accessible trial locations."

Answered by AI

Is this trial recruiting participants at the moment?

"The data hosted on clinicaltrials.gov confirms that this study is currently recruiting patients, with a commencement date of June 12th 2020 and the last edit being dated November 14th 2022."

Answered by AI

What is the aggregate amount of participants in this research?

"To fully launch this clinical trial, 48 individuals that pass the pre-determined criteria must be recruited. Emerson Clinical Research Institute in Falls Church, Virginia and Austin Research Center for Retina, PLLC in Austin, Texas are two of many potential sites where patients can join the study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Retina Consultants of Texas
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Apr 2025