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RECRUITING

NCT06321302

PHASE2

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: CRIMSON: A Multicentre, Randomised, Sham-controlled (and Active Controlled in the USA), Double-masked, 72-week Trial to Study the Safety, Tolerability, Pharmacokinetics, and Efficacy of 3 Dosing Regimens of Intravitreal BI 764524 in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2024-05-15

Completion Date

2027-09-17

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Diabetic Retinopathy

Interventions

DRUG

BI 764524

DRUG

Sham comparator to BI 764524

DRUG

Aflibercept (Eylea®) - US only

General inclusion criteria * Diagnosis of diabetes mellitus (DM) under regular treatment with Haemoglobin A1c (HbA1c) (glycated haemoglobin) (HbA1c) \<12%; DM should be under regular investigation by a trained specialist as per local standard of care prior to and during the trial * Age ≥18 years at time of signing Informed Consent Form (ICF) Ocular inclusion criteria: study eye * 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 Main exclusion criteria in study eye: \- Evidence of active retinal neovascularisation (NV) on clinical exam and/or ultra-widefield colour fundus photography (UWF-CFP) within the ETDRS 7-field, confirmed by the CRC grading 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

Locations (89)

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

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 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"

Naples, 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, 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

Clinical Research Directory

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (89)