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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
No Placebo-Only Group
Summary
This trial tests a new medicine called BI 771716 in adults aged 50 and older with a severe eye condition. The medicine is injected directly into the eye to check its safety and tolerance.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 112 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 112 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 771716
2023
Completed Phase 1
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF therapies and photodynamic therapy. Anti-VEGF treatments work by inhibiting the growth and leakage of abnormal blood vessels in the retina, which are a hallmark of AMD.
Photodynamic therapy involves the use of light-activated drugs to selectively destroy these abnormal vessels. These treatments are essential for AMD patients as they help to slow the progression of the disease and preserve vision, thereby improving quality of life.
The trial BI 771716, which involves direct eye injections, is likely exploring similar localized treatment approaches to enhance tolerance and efficacy.
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Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,897,275 Total Patients Enrolled
7 Trials studying Macular Degeneration
388 Patients Enrolled for Macular Degeneration