A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Launched by BOEHRINGER INGELHEIM · Dec 5, 2024

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ClinConnect Summary

This clinical trial is investigating a new treatment called BI 771716 for people aged 50 and older who have an advanced eye condition known as geographic atrophy, which is a type of age-related macular degeneration (AMD). The trial aims to compare the effectiveness of BI 771716 with another medicine called pegcetacoplan, which is already used to treat this condition. Participants will receive injections of either medicine in their eye and will be monitored closely by doctors over the course of about a year, with visits every four weeks to check their eye health and note any side effects.

To join the trial, participants need to be at least 50 years old and have a specific type of geographic atrophy affecting their vision. They should also have good vision in their other eye. If you're interested in participating, your doctor can help determine if you meet the necessary criteria. This study is a great opportunity to contribute to research that may lead to better treatments for geographic atrophy, and participants will receive regular check-ups and care throughout the process.

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Eligibility criteria

• • Inclusion criteria
• • Age at least 50 years old at the time of randomization visit
• • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• • Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use are provided in the participant information. Male participants must be ready and able to use either a condom or abstinence as contraceptive measures
• • Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), where the total GA lesion area must be ≥2.5 square millimetres (mm²) and ≤17.5 mm² as measured by Fundus autofluorescence (FAF)
• • If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥1.25 mm²
• • Note: Fellow eye is not required to have GA
• • Note: subfoveal GA lesions (defined as GA lesions within 1 micron of the foveal center point) will be allowed to be enrolled until a maximum is reached of 36 subfoveal lesions in the entire trial (36 is 20% of the total trial population of 180 participants). No more than 36 participants with subfoveal GA lesions should be enrolled. After the maximum of 36 participants is reached, then any participants with subfoveal GA lesions should not be enrolled
• • Fellow eye must have sufficient visual function compared to the study eye, per the investigator's medical judgment in consultation with the patient, to support the patient's daily functioning
• • BCVA letter score of ≥24 letters, using the ETDRS chart in the study eye (equivalent to ≥20/320 on the Snellen chart). Note: If both eyes meet eligibility criteria, the eye with the worse visual function per the investigator's medical judgment in consultation with the patient, will be selected as the study eye. If both eyes have similar visual function, the study eye will be selected per the investigator's medical judgment in consultation with the patient
• • further inclusion criteria apply
• • Exclusion criteria
• • GA lesions whose area cannot be accurately defined in the study eye
• • Exudative neovascular AMD (eAMD) in the study eye
• • -- Note: eAMD in the fellow eye is allowed
• • Previously received treatment in the study eye for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
• • Previously received an investigational medication (oral or intravitreal) for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
• • Currently enrolled in another investigational device or drug trial, or 30 days or 5 half-lives, whichever is longer since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Any previous use of gene therapy or cell therapy is not permitted
• * Additional eye disease as follows:
• • Any eye disease in the study eye that could compromise BCVA
• • Uncontrolled glaucoma or ocular hypertension with intraocular pressure \>24 millimetre of mercury (mmHg) in study eye
• • History of high myopia \>8 diopters in the study eye
• • Anterior segment and vitreous abnormalities that would preclude adequate observation with spectral domain optical coherence tomography in the study eye
• • Ocular conditions at the discretion of the investigator that might interfere with outcome of the trial in the study eye
• • Active intraocular inflammation in the study eye
• • Active infectious conjunctivitis in either eye
• • Prior vitrectomy surgery in the study eye
• • History of major intraocular surgeries including major corneal surgery. Uneventful cataract surgery, refractive surgery, oculoplastic surgery, strabismus surgery, and other extraocular surgery may be permitted if they have occurred more than 3 months prior to baseline in the study eye
• • further exclusion criteria apply