Sham comparator to BI 771716: Sham comparator to BI 771716
Study summary
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 771716 with a medicine called pegcetacoplan. BI 771716 is being developed to treat people with geographic atrophy. Pegcetacoplan is a medicine already used to treat people with geographic atrophy.
In this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye.
Participants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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 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
* 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. 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
* further exclusion criteria apply
Primary outcome measure(s)
Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) in the study eye expressed in millimeter (mm)/year — At Baseline , at Week 56
Trial sites (46)
Facility
City
Region
Status
Associated Retina Consultants
Gilbert
Arizona
Associated Retina Consultants, Ltd.
Phoenix
Arizona
Phoenix Retina Associates
Phoenix
Arizona
Retina Macula Institute of Arizona
Scottsdale
Arizona
Global Research Management
Glendale
California
Retina Associates of Southern California
Huntington Beach
California
Retinal Consultants Medical Group, Inc
Modesto
California
Eye Research Foundation
Newport Beach
California
Retina Consultants of San Diego
Poway
California
Retinal Consultants Medical Group
Sacramento
California
Bay Area Retina Associates - Walnut Creek
Walnut Creek
California
Colorado Retina Associates
Lakewood
Colorado
Connecticut Eye Consultants, PC
Danbury
Connecticut
Retina Group of New England, PC
Waterford
Connecticut
Rand Eye Institute
Deerfield Beach
Florida
Retina Group of Florida
Fort Lauderdale
Florida
Eye Associates of Pinellas
Pinellas Park
Florida
Retina Vitreous Associates of Florida
St. Petersburg
Florida
Southeast Retina Center, PC
Augusta
Georgia
University Retina and Macula Associates
Lemont
Illinois
Illinois Retina Associates - Oak Park
Oak Park
Illinois
Butchertown Clinical Trials
Louisville
Kentucky
Mid Atlantic Retina Specialists
Hagerstown
Maryland
Ophthalmic Consultants of Boston
Boston
Massachusetts
Retina Consultants of Minnesota
Edina
Minnesota
Mississippi Retina Associates
Madison
Mississippi
University of Missouri Health System
Columbia
Missouri
Envision Ocular, LLC
Bloomfield
New Jersey
Eye Associates of New Mexico
Albuquerque
New Mexico
Long Island Vitreoretinal Consultants - Westbury
Westbury
New York
Verum Research, LLC
Eugene
Oregon
Mid Atlantic Retina - Bethlehem
Bethlehem
Pennsylvania
Charleston Neuroscience Institute - Charleston
Charleston
South Carolina
Tennessee Retina
Nashville
Tennessee
Austin Clinical Research, LLC
Austin
Texas
Retina Consultants of Texas-Beaumont-70319
Beaumont
Texas
Retina Consultants of Texas-Bellaire-67493
Bellaire
Texas
Retina Foundation of the Southwest
Dallas
Texas
Retina Consultants of Texas - Katy
Katy
Texas
Red River Research Partners, LLC
Plano
Texas
+ 6 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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