What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) injections such as ranibizumab, aflibercept, and bevacizumab. These treatments, similar to the BI 771716 injections being studied, are administered directly into the eye. Known side effects of these treatments include eye pain, increased intraocular pressure, inflammation, and risk of infection. Less commonly, patients may experience retinal detachment or hemorrhage. Regular monitoring by an ophthalmologist is essential to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD), particularly for the neovascular (wet) form of the disease. These include anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and brolucizumab (Beovu), which are administered via intravitreal injections. These treatments work by inhibiting the growth of abnormal blood vessels in the retina. While BI 771716 is being studied for geographic atrophy, a form of advanced AMD, it is similar in that it involves direct ocular administration. However, specific FDA-approved treatments for geographic atrophy are limited, with ongoing research aimed at finding effective therapies.

What other types of research exist?

Promising novel alternatives to BI 771716 for Age-Related Macular Degeneration (AMD) patients include: 1) Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, which has shown positive results in clinical trials for reducing retinal fluid and improving vision. 2) Gene therapy approaches like RGX-314, which aims to provide a long-term solution by delivering a gene encoding for an anti-VEGF protein directly to retinal cells. 3) Complement inhibitors such as Pegcetacoplan, which target the complement system involved in AMD pathogenesis and have demonstrated efficacy in reducing the progression of geographic atrophy in AMD patients.

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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

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

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

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 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 771716

2023

Completed Phase 1

~20

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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

2,534 Previous Clinical Trials

11,357,507 Total Patients Enrolled

~10 spots leftby Sep 2025

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