A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
NCT ID: NCT06321302
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
178 participants
INTERVENTIONAL
2024-05-15
2027-09-17
Brief Summary
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The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance. Participants in groups 1, 2, and 3 get BI 764524. Over 1 year, they get a different number of injections of the same dose of BI 764524 injected into 1 eye. During some visits, participants may get a sham control, which is done like an eye injection but without a needle, so that participants will not know how many injections of BI 764524 they received. Participants in group 4 only get a sham control. Participants in group 5 (only in the USA) get aflibercept or sham injections during some visits. Aflibercept is a medicine already used to treat diabetic retinopathy.
Participants are in the study for one and a half years. During this time, they visit the study site at least 16 times. During this time, doctors regularly do eye exams and visual tests to assess the severity of participants' eye condition. After 1 year of treatment, researchers look at the number of participants with eye improvements. To do so, they compare eye damage and certain severe eye problems between the groups of participants. The doctors also regularly check participants' health and take note of any unwanted effects.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BI 764524
BI 764524
BI 764524
BI 764524
Sham comparator to BI 764524
Sham comparator to BI 764524
Sham comparator to BI 764524
Sham comparator to BI 764524
Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only
Interventions
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BI 764524
BI 764524
Sham comparator to BI 764524
Sham comparator to BI 764524
Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years at time of signing Informed Consent Form (ICF)
* Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (Diabetic Retinopathy Severity Scale (DRSS) 47 to 53) based on early treatment diabetic retinopathy study (ETDRS) 7-field grading as confirmed by the central reading centre (CRC) at screening
* Ultra-widefield fluorescein angiography (UWF-FA) image gradable for presence of retinal non-perfusion (RNP) as confirmed by the CRC at screening
* Visual acuity: best corrected visual acuity (BCVA) letter score of ≥49 letters (approximate Snellen equivalent of 20/100 or better) using ETDRS chart at starting distance of 4 meter (m) at screening
* Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
Exclusion Criteria
The following are permitted if, based on the assessment of the investigator, do not require acute treatment:
* Small neovascular lesions within the ETDRS 7-field that are detected only on UWF-FA, but not on clinical exam or colour fundus photography (CFP)
* Neovascularisations outside of the ETDRS 7-field on ultra-widefield imaging
* Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle
* Prior pan-retinal photocoagulation (PRP). Peripheral scatter or targeted laser treatment in up to 1 quadrant outside the ETDRS 7-field area is permitted if it was performed at least 6 months prior to Day 1
* CI-DME, defined as central subfield thickness (CST) ≥320 micrometer (μm) as measured by Heidelberg Spectralis optical coherence tomography (OCT) and confirmed by central reading centre (CRC) at screening (equivalent measurements from other OCT machines may be accepted); participants with a CST of 320-330 μm can be included if, in the opinion of the investigator, the participant is not expected to require treatment for CI-DME during the duration of the study (e.g. no profound impact on BCVA, stable CST, etc.)
* Previous treatment in the study eye for NPDR and/or diabetic macular edema (DME) with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) (including anti-VEGF/Ang2) or short acting corticosteroid drugs (e.g. triamcinolone) within 6 months prior to Day 1 or dexamethasone intravitreal drug delivery system (Ozurdex) within 12 months prior to Day 1 (referred to elsewhere as 'previous IVT treatment').
* Any previous IVT treatment other than anti-VEGF, and steroids. Previous fluocinolone acetonide intravitreal implant (Iluvien) is not allowed
* Refractive error of more than -8 dioptres of myopia (spherical equivalent) in the study eye. For patients having undergone refractive or cataract surgery in the study eye, either the pre-operative refractive error or the axial length measurement should be used, at the investigator's discretion. Axial length should be less than 26 mm
* Any concurrent or past ocular condition in the study eye which, in the judgement of the investigator, could:
* Require medical or surgical intervention during the study period to prevent or treat vision loss (e.g. advanced cataract, history of retinal detachment or macular hole (Stage 3 or 4) in the study eye)
* Could likely contribute to a significant loss of BCVA during the study period if left untreated (e.g. advanced epiretinal membrane and/or vitreomacular traction, active or history of optic neuritis in either eye)
* Contraindicate the use of the investigational drug, or may render the patient at high risk for treatment complications (e.g. active infectious or non-infectious conjunctivitis/keratitis in either eye; history of recurrent infectious or inflammatory ocular disease in either eye (e.g. uveitis)
* May affect interpretation of the study results (e.g. central atrophy of the retinal pigment epithelium or photoreceptors; age-related macular degeneration, hereditary retinal degenerative diseases, myopic macular degeneration, past, current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. deferoxamine, chloroquine/hydroxychloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol); history of central serous chorioretinopathy, ischemic optic neuropathy or retinal vascular occlusion
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
California Retina Consultants-Bakersfield-65523
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Diagnostic Center
Campbell, California, United States
The Retina Partners
Encino, California, United States
Lugene Eye Institute
Glendale, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
Byers Eye Institute
Palo Alto, California, United States
California Eye Specialists Medical Group Inc
Pasadena, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
California Retina Consultants-Santa Maria-65510
Santa Maria, California, United States
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States
Colorado Retina Associates
Lakewood, Colorado, United States
Retina Group of New England, PC
Waterford, Connecticut, United States
Florida Retina Institute
Jacksonville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Retina Consultants Of Hawaii
‘Aiea, Hawaii, United States
Maine Eye Center
Portland, Maine, United States
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi, United States
NJRetina
Teaneck, New Jersey, United States
Long Island Vitreoretinal Consultants
Great Neck, New York, United States
Retina Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
EyeHealth Northwest
Portland, Oregon, United States
Charleston Neuroscience Institute - Ladson
Ladson, South Carolina, United States
Tennessee Retina
Nashville, Tennessee, United States
Austin Retina Associates
Austin, Texas, United States
Retina Research Center, PLLC
Austin, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas
Katy, Texas, United States
Valley Retina Institute, PA
McAllen, Texas, United States
Austin Retina Associates
Round Rock, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
Retina Consultants of Texas - Schertz
Schertz, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
Universitätsklinikum Bonn AöR
Bonn, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Dietrich-Bonhoeffer-Klinikum
Neubrandenburg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Semmelweis University
Budapest, , Hungary
Budapest Retina Associations Kft.
Budapest, , Hungary
Jahn Ferenc Del-Pest Hospital
Budapest, , Hungary
University Debrecen Hospital
Debrecen, , Hungary
Nozologen Kft.
Pécs, , Hungary
Zala Megyei Szent Rafael Korhaz
Zala, , Hungary
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele S.r.l.
Milan, , Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, , Italy
IRCCS Fondazione Bietti
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Ospedali Riuniti di Ancona
Torrette Di Ancona, , Italy
Akita University Hospital
Akita, , Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki-shi, , Japan
Hayashi Eye Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, , Japan
Kagawa University Hospital
Kagawa, Kita-gun, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Nara Medical University Hospital
Kashihara, , Japan
Kobe University Hospital
Kobe, , Japan
Shinshu University Hospital
Matsumoto-shi, , Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, , Japan
Aichi Medical University Hospital
Nagakute, , Japan
Hyogo College of Medicine Hospital
Nishinomiya, , Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, , Japan
Klinika Okulistyczna
Bydgoszcz, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, , Poland
Warsaw Ophthalmology Hospital
Warsaw, , Poland
Centrum Medyczne Piasta 47 sp. z o.o.
Wałbrzych, , Poland
4. Military Clinical Hospital with Polyclinic SP ZOZ
Wroclaw, , Poland
Emanuelli Research & Development Center
Arecibo, , Puerto Rico
Hospital Universitari de Bellvitge
Barcelon, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitari General de Catalunya
Sant Cugat Del Vallés, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
East Suffolk and North Essex NHS Foundation Trust
Colchester, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Western Eye Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
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Related Links
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Related Info
Other Identifiers
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1436-0007
Identifier Type: -
Identifier Source: org_study_id
2023-508891-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1299-0915
Identifier Type: REGISTRY
Identifier Source: secondary_id