A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
- Conditions
- Diabetic Retinopathy
- Interventions
- Registration Number
- NCT06321302
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study.
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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 764524 BI 764524 BI 764524 Aflibercept (Eylea®) - US only Aflibercept (Eylea®) - US only Aflibercept (Eylea®) - US only Sham comparator to BI 764524 Sham comparator to BI 764524 Sham comparator to BI 764524
- Primary Outcome Measures
Name Time Method Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52 At baseline and at Week 52 The DRSS is a scale which can take on the following discrete values: 10, 20, 35, 43, 47, 53, 61, 65, 71, 75, 81, 85.
Here 10 means "No retinopathy" and 85 means "Advanced proliferative diabetic retinopathy, with posterior fundus obscured, or centre of macula detached".
Thus, a higher score means symptoms get worse.
- Secondary Outcome Measures
Name Time Method Absolute change from baseline of central retinal thickness [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52 At baseline and at Week 52 μm= micrometer
Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52 At baseline and at Week 52 Occurrence of vision threatening complications (VTC)s in the study eye between baseline and Week 52 At baseline and at Week 52 Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52 At baseline and at Week 52 The BCVA score is the number of letters read correctly by the patient.
Occurrence of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52 At baseline and at Week 52 Occurrence of ocular AEs in the study eye between baseline and EOS up to 72 weeks Occurrence of ocular AEs of special interest in the study eye between baseline and EOS up to 72 weeks Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52 At baseline and at Week 52 The DRSS is a scale which can take on the following discrete values: 10, 20, 35, 43, 47, 53, 61, 65, 71, 75, 81, 85.
Here 10 means "No retinopathy" and 85 means "Advanced proliferative diabetic retinopathy, with posterior fundus obscured, or centre of macula detached".
Thus, a higher score means symptoms get worse.Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS) up to 72 weeks
Trial Locations
- Locations (78)
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
Lugene Eye Institute
🇺🇸Glendale, California, United States
Retina Associates of Southern California
🇺🇸Huntington Beach, California, United States
American Institute of Research, Inc
🇺🇸Los Angeles, 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
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
Deep Blue Retina Clinical Research PLLC
🇺🇸Southaven, Mississippi, United States
NJRetina
🇺🇸Teaneck, New Jersey, 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
Retina Research Center, PLLC
🇺🇸Austin, Texas, United States
Austin Clinical Research, LLC
🇺🇸Austin, Texas, United States
Valley Retina Institute, PA
🇺🇸McAllen, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Retina Consultants of Houston, PA-The Woodlands-66484
🇺🇸The Woodlands, 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 Ltd.
🇭🇺Budapest, Hungary
Jahn Ferenc Del-Pest Hospital
🇭🇺Budapest, Hungary
University Debrecen Hospital
🇭🇺Debrecen, Hungary
Ganglion Orvosi Kozpont
🇭🇺Pecs, Hungary
Zala Megyei Szent Rafael Korhaz
🇭🇺Zala, Hungary
Azienda Ospedaliera Universitaria Federico II
🇮🇹Campobasso, Italy
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
IRCCS San Raffaele
🇮🇹Milano, 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, Japan
Hayashi Eye Hospital
🇯🇵Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Tokyo Medical University Hachioji Medical Center
🇯🇵Hachioji-shi, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Japan
Kobe University Hospital
🇯🇵Kobe, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-ku, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Japan
Juntendo University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Klinika Okulistyczna
🇵🇱Bydgoszcz, Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
🇵🇱Olsztyn, Poland
Centrum Medyczne Piasta 47 sp. z o.o.
🇵🇱Walbrzych, Poland
Warsaw Ophthalmology Hospital
🇵🇱Warszawa, Poland
4. Military Clinical Hospital with Polyclinic SP ZOZ
🇵🇱Wroclaw, Poland
Emanuelli Research & Development Center
🇵🇷Arecibo, Puerto Rico
University Hospital of Bellvitge
🇪🇸Barcelona, 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
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom