BI 771716 for Age-Related Macular Degeneration

No longer recruiting at 14 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Disqualifiers: Women of childbearing potential, Exudative CNV, Recent GA treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different doses of BI 771716 are tolerated by individuals with geographic atrophy, a severe form of age-related macular degeneration (AMD) that affects vision. Participants will receive injections of BI 771716 in the eye to assess their response to the treatment. This study marks the first time this medicine is tested on humans. Individuals with geographic atrophy due to AMD, whose vision is better in one eye than the other, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol mentions a medication washout period, which means you may need to stop taking certain medications before participating. However, it does not specify which medications are affected, so it's best to discuss this with the trial doctors.

Is there any evidence suggesting that BI 771716 is likely to be safe for humans?

Research has shown that BI 771716 has been safely tested in both single and multiple doses. In earlier studies, this treatment met its main safety goals when administered as eye injections, indicating it was well-tolerated by recipients.

Although this trial marks the first time BI 771716 is tested in humans, previous research provides some reassurance about its safety. The treatment is part of an antibody specifically designed to target the condition.

These findings suggest that BI 771716 is generally safe for people with geographic atrophy. However, as this is a Phase 1 trial, the main focus is on identifying any side effects and ensuring safety at different doses. Researchers will closely monitor participants throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for age-related macular degeneration?

Unlike the standard treatments for age-related macular degeneration, which often involve anti-VEGF injections, BI 771716 offers a novel approach by potentially targeting a different pathway to slow or stop the progression of the disease. This treatment is unique because it explores varying doses, from low to high, to assess the optimal therapeutic effect. Researchers are particularly excited about BI 771716 as it may provide an alternative for patients who do not respond well to existing therapies, offering hope for improved vision outcomes and quality of life.

What evidence suggests that BI 771716 might be an effective treatment for age-related macular degeneration?

Research has shown that BI 771716 may help treat geographic atrophy, a severe form of age-related macular degeneration. Early results from similar studies have been positive, suggesting that this treatment might slow the condition's progression. BI 771716 targets specific proteins in the eye that cause vision loss. In this trial, participants will receive different doses of BI 771716 to assess its effectiveness and safety. Although this is the first human trial for BI 771716, earlier research has been promising, indicating potential benefits in managing the condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have advanced age-related vision loss with a specific lesion size.

I am 50 years old or older.

Fellow eye is not required to have GA

Exclusion Criteria

I have or had wet macular degeneration in my study eye.

I am not able to have children due to surgery or I am postmenopausal.

I have had gene or cell therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1 Treatment

Participants receive 1 injection of BI 771716 directly into one of the eyes affected by geographic atrophy

3 months

1 visit (in-person)

Part 2 Treatment

Participants receive 2 injections of BI 771716 directly into the eye, with 4 weeks between injections

4 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 771716

Trial Overview 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.

How Is the Trial Designed?

Group I: BI 771716 treatment group (multiple dose (MD part)) Experimental Treatment 1 Intervention

Group II: BI 771716 medium dose treatment group (SRD part) Experimental Treatment 1 Intervention

Group III: BI 771716 low dose treatment group (Single rising dose (SRD part)) Experimental Treatment 1 Intervention

Group IV: BI 771716 high dose treatment group (SRD part) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06722157

NCT06722157 | A Study to Test Whether BI 771716 Helps ... This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a medicine called BI ...

2. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/geographic-atrophy-treatment-move-phase-ii

Geographic Atrophy treatment to move to Phase II Boehringer Ingelheim and CDR-Life today announce positive results from the Phase I evaluation of BI 771716 (Study Record ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/boehringer-geographic-atrophy-trial/

Boehringer, CDR-Life report data from geographic atrophy ... Boehringer Ingelheim and CDR-Life have reported positive outcomes from the Phase I clinical trial of BI 771716, a new treatment for geographic atrophy (GA).

4. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-geographic-atrophy

Phase II start of oral treatment for Geographic Atrophy A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy ( ...

5. ctv.veeva.com ctv.veeva.com/study/a-study-to-test-whether-bi-771716-helps-people-with-an-advanced-form-of-age-related-macular-degenera

A Study to Test Whether BI 771716 Helps People With an ... This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a ...

6. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/boehringer-geographic-atrophy-trial-first-in-class-therapy

Boehringer Announces Start of Phase II Geographic ... In the study (NCT06006585), BI 771716 achieved its primary safety endpoint following intravitreal administration of single and multiple doses. 3.