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Monoclonal Antibodies

BI 771716 for Age-Related Macular Degeneration

Phase 1
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 up to 112 days
Awards & highlights

Study Summary

This trial studies a new medicine for age-related macular degeneration. Participants get 1-2 injections of BI 771716 directly in the eye & doctors track their health.

Who is the study for?
Adults over 50 with geographic atrophy due to age-related macular degeneration can join this study. They must have a certain level of vision in the affected eye and better vision in the other eye. Men who can father children must use effective birth control, and all participants need to sign informed consent.Check my eligibility
What is being tested?
The trial is testing how well different doses of BI 771716 are tolerated when injected into the eye of patients with geographic atrophy. Part 1 involves one injection over three months, while Part 2 includes two injections four weeks apart over four months.See study design
What are the potential side effects?
Since BI 771716 is being given to humans for the first time, specific side effects are not listed but will be monitored by doctors throughout the study as they assess general health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 112 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 112 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS)
Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8
Secondary outcome measures
Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
BI 771716 serum concentration
Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: BI 771716 treatment group (multiple dose (MD part))Experimental Treatment1 Intervention
Group II: BI 771716 medium dose treatment group (SRD part)Experimental Treatment1 Intervention
Group III: BI 771716 low dose treatment group (Single rising dose (SRD part))Experimental Treatment1 Intervention
Group IV: BI 771716 high dose treatment group (SRD part)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,272 Total Patients Enrolled

Frequently Asked Questions

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

Are there still spots open for participants in this clinical trial?

"Affirmative. Clinicaltrials.gov details that this clinical trial is welcoming participants, with the first post date being September 12th 2023 and an update on September 29th of the same year. 24 patients must be recruited from 7 sites to complete the study."

Answered by AI

Has the FDA granted approval for BI 771716's single rising dose (SRD part) regimen of low-dose treatment?

"The safety of the BI 771716 low dose treatment group (Single rising dose (SRD part)) was assigned a score of 1 as it is in Phase 1 trials, with limited evidence supporting its efficacy and safety."

Answered by AI

What is the cap for participants in this research endeavor?

"To be successful, this trial necessitates the recruitment of 24 qualified participants. The sponsor, Boehringer Ingelheim is running it remotely from Retina Associates in Lenexa and Verum Research located in Eugene respectively."

Answered by AI

How many separate sites are managing this clinical trial?

"Patients are being accepted at Retina Associates, LLC in Lenexa, Kansas; Verum Research, LLC in Eugene, Oregon; Erie Retina Research, LLC in Erie Pennsylvania and 7 other medical centres."

Answered by AI

What is the purpose of this clinical trial?

"The primary goal of this clinical trial, to be assessed over a period up to 112 days, is the appearance of ocular dose limiting events (DLEs) post-administration until Day 8. In addition, secondary objectives involve obtaining time from dosing to highest serum concentration of BI 771716 (tmax), evaluating BI 771716 blood levels (MD part), and monitoring for any adverse effects in the observed eye after administration until conclusion of study (SRD part)."

Answered by AI

Who else is applying?

What site did they apply to?
Florida Retina Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am really concerned about the GA progressing.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
2023. "A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006585.
All > Age Related Macular Degeneration > Geographic Atrophy
~0 spots leftby May 2024
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