BI 771716 for Age-Related Macular Degeneration

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

20 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Fellow eye is not required to have GA

Best corrected visual acuity (BCVA) in the non-study eye must have a better BCVA compared to the study eye

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

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

Treatment Details

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.

Participant Groups

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+