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

NCT06321302 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 1436-00072023-508891-12-00U1111-1299-0915
• Study Type: interventional
• Target: 190
• Locations: 9 countries
• Sites: 89

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52 as assessed by Ultra-widefield colour fundus photography (UWF-CFP) images (within the 7-field grid)

  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.

  At baseline and at Week 52

Secondary Outcomes (9)

• Occurrence of vision threatening complications (VTC)s defined as proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV), or development of CI-DME, 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

• Absolute change from baseline of central subfield thickness (CST) [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52

  At baseline and at Week 52

• Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52 as assessed by UWF-CFP images (within the 7-field grid)

  At baseline and at Week 52

• 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

Study Arms (3)

BI 764524

EXPERIMENTAL

BI 764524

Drug: BI 764524

Sham comparator to BI 764524

SHAM COMPARATOR

Sham comparator to BI 764524

Drug: Sham comparator to BI 764524

Aflibercept (Eylea®) - US only

ACTIVE COMPARATOR

Aflibercept (Eylea®) - US only

Drug: Aflibercept (Eylea®) - US only

Interventions

BI 764524 DRUG

BI 764524

BI 764524

Sham comparator to BI 764524 DRUG

Sham comparator to BI 764524

Sham comparator to BI 764524

Aflibercept (Eylea®) - US only DRUG

Aflibercept (Eylea®) - US only

Aflibercept (Eylea®) - US only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Moderate to severe non-proliferative diabetic retinopathy (NPDR) (Diabetic Retinopathy Severity Scale (DRSS) level 43 to 53) as assessed by Ultra-widefield colour fundus photography (UWF-CFP) images (within the 7-field grid) and confirmed by the central reading centre (CRC) at screening. Patient staged at DRSS level of 43 based on UWF-CFP images can be included only if:
• They are participating in the standard 7-field CFP sub-study of the trial, and
• They are staged as DRSS level of 47 to 53 on standard 7-field CFP imaging, as confirmed by the 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 and reconfirmed at baseline
• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

You may not qualify if:

• \- Evidence of active retinal neovascularisation (NV) on clinical exam and/or UWF-CFP images within the 7-field grid, 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 UWF-CFP
• Neovascularisations outside of the ETDRS 7-field on ultra-widefield imaging
• 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.). CST must be re-confirmed at baseline. A CRC confirmation of the baseline CST is not required.
• 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 \>4 treatments within the last 18 months (referred to elsewhere as 'previous IVT treatment').
• Any previous IVT treatment other than anti-VEGF and short-acting steroids. Previous dexamethasone IVT drug delivery system (Ozurdex) or 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (89)

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

California Retina Consultants-Bakersfield-65523

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retinal Diagnostic Center

Campbell, California, 95008, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Lugene Eye Institute

Glendale, California, 91204, United States

Location

Retina Associates of Southern California

Huntington Beach, California, 92647, United States

Location

Byers Eye Institute

Palo Alto, California, 94303, United States

Location

California Eye Specialists Medical Group Inc

Pasadena, California, 91107, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95841, United States

Location

California Retina Consultants-Santa Maria-65510

Santa Maria, California, 93454, United States

Location

Bay Area Retina Associates - Walnut Creek

Walnut Creek, California, 94598, United States

Location

Colorado Retina Associates

Lakewood, Colorado, 80228, United States

Location

Retina Group of New England, PC

Waterford, Connecticut, 06385, United States

Location

Florida Retina Institute

Jacksonville, Florida, 32216, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Retina Consultants Of Hawaii

‘Aiea, Hawaii, 96701, United States

Location

Maine Eye Center

Portland, Maine, 04101, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Deep Blue Retina Clinical Research PLLC

Southaven, Mississippi, 38671, United States

Location

NJRetina

Teaneck, New Jersey, 07666, United States

Location

Long Island Vitreoretinal Consultants

Great Neck, New York, 11021, United States

Location

Retina Vitreous Surgeons of Central NY, PC

Liverpool, New York, 13088, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Charleston Neuroscience Institute - Ladson

Ladson, South Carolina, 29456, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Research Center, PLLC

Austin, Texas, 78705, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Austin Retina Associates

Round Rock, Texas, 78681, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas - Schertz

Schertz, Texas, 78154, United States

Location

Retina Associates of Utah

Salt Lake City, Utah, 84107, United States

Location

Universitätsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Diakonie Klinikum Dietrich Bonhoeffer GmbH

Neubrandenburg, 17036, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Semmelweis University

Budapest, 1085, Hungary

Location

Budapest Retina Associations Kft.

Budapest, 1133, Hungary

Location

Jahn Ferenc Del-Pest Hospital

Budapest, 1204, Hungary

Location

University Debrecen Hospital

Debrecen, 4032, Hungary

Location

Nozologen Kft.

Pécs, 7621, Hungary

Location

Zala Megyei Szent Rafael Korhaz

Zala, 8900, Hungary

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

Location

Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria "Federico II"

Naples, 80131, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Ospedali Riuniti di Ancona

Torrette Di Ancona, 60123, Italy

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki-shi, 660-8550, Japan

Location

Hayashi Eye Hospital

Fukuoka, 812-0011, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Tokyo Medical University Hachioji Medical Center

Hachioji-shi, 193-0998, Japan

Location

Kagawa University Hospital

Kagawa, Kita-gun, 761-0793, Japan

Location

Kagoshima University Hospital

Kagoshima, 890-8520, Japan

Location

Nara Medical University Hospital

Kashihara, 634-8522, Japan

Location

Kobe University Hospital

Kobe, 650-0017, Japan

Location

Shinshu University Hospital

Matsumoto-shi, 390-8621, Japan

Location

National Hospital Organization Tokyo Medical Center

Meguro-ku, 152-8902, Japan

Location

Aichi Medical University Hospital

Nagakute, 480-1195, Japan

Location

Hyogo College of Medicine Hospital

Nishinomiya, 663-8501, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Klinika Okulistyczna

Bydgoszcz, 85-631, Poland

Location

Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.

Olsztyn, 10-424, Poland

Location

Warsaw Ophthalmology Hospital

Warsaw, 01-258, Poland

Location

Centrum Medyczne Piasta 47 sp. z o.o.

Wałbrzych, 58-304, Poland

Location

4. Military Clinical Hospital with Polyclinic SP ZOZ

Wroclaw, 50-981, Poland

Location

Emanuelli Research & Development Center

Arecibo, 00612, Puerto Rico

Location

Hospital Universitari de Bellvitge

Barcelon, 08907, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat Del Vallés, 08195, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Colchester Hospital

Colchester, CO4 5JL, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Western Eye Hospital

London, NW1 5QH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Central Middlesex Hospital

London, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (40); PL (5); JP (14); ES (5); DE (5); GB (7); HU (6); IT (6); PR (1)