Clareo Health | A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 of approximately 60% of participants with subfoveal GA lesions are enrolled. Participants with subfoveal GA lesions already in screening at the time the cap has been reached may be considered for randomization.
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
You may not be if
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. However, if the fellow eye is to be considered for microperimetry and other analyses (as defined in the trial statistical analysis plan), then eAMD is not allowed in either eye.
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
