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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1309-9115 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This study is open to adults aged 50 years and older with geographic atrophy that was diagnosed by imaging of the retina. The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable dose.
This study has 4 treatment groups. Participants are put into groups randomly, which means by chance. Initially participants can join a BI 1584862 and a placebo group; then more participants are put randomly in 2 additional BI 1584862 groups and a placebo group.
Participants are in the study for 1 year. During this time, they visit the study site 13 times. At the visits, doctors check the severity of participants' eye disease and collect information on any health problems. They take detailed pictures of the back of the eye, the retina, with imaging methods called fundus autofluorescence (FAF), near-infrared reflectance (NIR), and optical coherence tomography (OCT). They measure areas of the retina that appear healthy (bright) or start to waste away (dark, atrophy). The changes over time are then compared between the treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-matching BI 1584862 | Placebo Comparator |
| |
| BI 1584862 dose 1 | Experimental |
| |
| BI 1584862 dose 2 | Experimental |
| |
| BI 1584862 dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo-matching BI 1584862 | Drug | Placebo-matching BI 1584862 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) over a treatment period of up to 50 weeks (expressed in mm/year) in the study eye | mm is millimeters. | Up to week 50. |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a thickness of 0 μm up to week 50 assessed by volumetric OCT and EZ mapping in the study eye | EZ stands for ellipsoid zone. OCT stands for optical coherence tomography. | Up to week 50. |
| Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye |
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Inclusion criteria:
Men and women with at least 1 eye with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) determined by fundus autofluorescence (FAF). The total size of all GA lesions in the study eye (as determined by the independent central reading center (CRC)) must be ≥1.25 mm^2 and ≤12.0 mm^2:
Best corrected visual acuity (BCVA) score of ≥50 letters in the study eye using the early treatment diabetic retinopathy study (ETDRS) chart (approximately equivalent to ≥20/100 on the Snellen chart).
Hyperautofluorescence of any pattern, as assessed by the CRC, must be present in the junctional zone of GA in the study eye.
Age ≥50 years.
Men must be willing and able to use contraception (condom, abstinence) to prevent pregnancy and/or exposure of an existing embryo or fetus to the investigational product. A female participant is eligible if she is not a woman of childbearing potential.
Signed informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH GCP) guidelines and local legislation
Exclusion criteria:
Any history of, or evidence of, exudative age-related macular degeneration (eAMD) in the study eye.
Previously received treatment for GA in the study eye within 4 months or 5 half-lives, prior to baseline, whichever is longer.
Previously received an investigational medication (oral or intravitreal) for GA within 4 months or 5 half-lives prior to baseline, whichever is longer.
Additional eye disease in the study eye that could compromise BCVA or significantly impact retinal morphology:
Significant disease or other medical conditions (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following:
Known hypersensitivity to any of the ingredients used in the investigational medicinal product (IMP) formulation, or any of the medications used.
Active intraocular inflammation in the study eye.
Active infectious conjunctivitis in either eye. Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Gilbert | Arizona | 85297 | United States | ||
| Associated Retina Consultants, Ltd. |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a 'Document Sharing Agreement'.
For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| BI 1584862 |
| Drug |
BI 1584862 |
|
GA stands for geographic atrophy. OCT stands for optical coherence tomography. mm is millimeters. |
| Up to week 50. |
| Occurrence of TEAES from drug administration until Week 52 | Up to week 52. |
| Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickness <20 micrograms (μm) up to week 50 assessed by volumetric optical coherence tomography (OCT) in the study eye | Up to week 50. |
| Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) at Week 50 (expressed in mm) in the study eye | At baseline and at week 50. |
| Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at least 2 consecutive visits between baseline and up to Week 50 | ETDRS is early treatment diabetic retinopathy study. | Up to week 50. |
| Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart under low-luminance conditions at Week 50 in the study eye | ETDRS is early treatment diabetic retinopathy study. | At baseline and at week 50. |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Cameron Ria, LLC | Phoenix | Arizona | 85050 | United States |
| Retina Macula Institute of Arizona | Scottsdale | Arizona | 85255 | United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Global Research Management | Glendale | California | 91204 | United States |
| Retina Associates of Southern California | Huntington Beach | California | 92647 | United States |
| Retinal Consultants Medical Group, Inc | Modesto | California | 95356 | United States |
| Northern California Retina Vitreous Associates MedicalGroup, Inc. | Mountain View | California | 94040 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Retina Consultants of San Diego | Poway | California | 92064 | United States |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | United States |
| Bay Area Retina Associates - Walnut Creek | Walnut Creek | California | 94598 | United States |
| Retina Specialists of Colorado Research, LLC | Denver | Colorado | 80222 | United States |
| Coastal Eye Surgeons | Greenwich | Connecticut | 06830 | United States |
| Vitreo Retinal Associates - Gainesville | Gainesville | Florida | 32605 | United States |
| MedEye Associates | Miami | Florida | 33143 | United States |
| Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | United States |
| Illinois Retina Associates - Oak Park | Oak Park | Illinois | 60304 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
| NJRetina | Teaneck | New Jersey | 07666 | United States |
| Verum Research, LLC | Eugene | Oregon | 97401 | United States |
| Retina Northwest | Portland | Oregon | 97221 | United States |
| EyeHealth Northwest | Portland | Oregon | 97225 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Charleston Neuroscience Institute - Charleston | Charleston | South Carolina | 29414 | United States |
| Tennessee Retina | Nashville | Tennessee | 37203 | United States |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | United States |
| Retina Consultants of Texas-Beaumont-70319 | Beaumont | Texas | 77707 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| Red River Research Partners, LLC - Plano | Plano | Texas | 75024 | United States |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas - Schertz | Schertz | Texas | 78154 | United States |
| Retina Consultants of Texas-The Woodlands-67575 | The Woodlands | Texas | 77384 | United States |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22042 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| Pacific Northwest Retina | Bellevue | Washington | 98004 | United States |
| Emanuelli Research & Development Center | Arecibo | 00612 | Puerto Rico |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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