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New eye injection aims to halt diabetic vision loss

NCT ID NCT06321302

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 12 times

Summary

This study tests an experimental drug called BI 764524, given as an eye injection, in 190 adults with moderate to severe diabetic retinopathy. Participants receive different numbers of injections over a year, and doctors compare eye damage improvements against a sham procedure or an existing drug (aflibercept). The goal is to see if BI 764524 can safely improve the condition and prevent vision-threatening complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 764524 (eye injection)
What this could lead to
If it works, this could provide a new treatment option to slow or improve diabetic retinopathy and reduce the risk of vision loss.
What could go wrong
This is an early Phase 2 trial with only 190 participants, so results may not confirm effectiveness. The treatment involves eye injections, which carry risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

190 people

The number who actually took part.

Started

May 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 Main exclusion criteria in study eye: \- 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 * 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.). 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

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Conditions

The condition(s) this trial relates to.

background diabetic retinopathy diabetic retinopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic retinopathy

Contacts and locations

Locations

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, 50-981, Poland

  • Aichi Medical University Hospital

    Nagakute, 480-1195, Japan

  • Akita University Hospital

    Akita, 010-8543, Japan

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona, 85020, United States

  • Austin Clinical Research, LLC

    Austin, Texas, 78750, United States

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Austin Retina Associates

    Round Rock, Texas, 78681, United States

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134, Italy

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California, 94598, United States

  • Budapest Retina Associations Kft.

    Budapest, 1133, Hungary

  • Byers Eye Institute

    Palo Alto, California, 94303, United States

  • California Eye Specialists Medical Group Inc

    Pasadena, California, 91107, United States

  • California Retina Consultants-Bakersfield-65523

    Bakersfield, California, 93309, United States

  • California Retina Consultants-Santa Maria-65510

    Santa Maria, California, 93454, United States

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880, United States

  • Central Middlesex Hospital

    London, United Kingdom

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

    Olsztyn, 10-424, Poland

  • Centrum Medyczne Piasta 47 sp. z o.o.

    Wałbrzych, 58-304, Poland

  • Charleston Neuroscience Institute - Ladson

    Ladson, South Carolina, 29456, United States

  • Colchester Hospital

    Colchester, CO4 5JL, United Kingdom

  • Colorado Retina Associates

    Lakewood, Colorado, 80228, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Deep Blue Retina Clinical Research PLLC

    Southaven, Mississippi, 38671, United States

  • Diakonie Klinikum Dietrich Bonhoeffer GmbH

    Neubrandenburg, 17036, Germany

  • East Florida Eye Institute

    Stuart, Florida, 34994, United States

  • Emanuelli Research & Development Center

    Arecibo, 00612, Puerto Rico

  • EyeHealth Northwest

    Portland, Oregon, 97225, United States

  • Florida Retina Consultants

    Lakeland, Florida, 33805, United States

  • Florida Retina Institute

    Jacksonville, Florida, 32216, United States

  • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fukushima Medical University Hospital

    Fukushima, 960-1295, Japan

  • Hayashi Eye Hospital

    Fukuoka, 812-0011, Japan

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Hospital Universitari General de Catalunya

    Sant Cugat Del Vallés, 08195, Spain

  • Hospital Universitari de Bellvitge

    Barcelon, 08907, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hyogo College of Medicine Hospital

    Nishinomiya, 663-8501, Japan

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki-shi, 660-8550, Japan

  • IRCCS Fondazione Bietti

    Roma, 00198, Italy

  • Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Jahn Ferenc Del-Pest Hospital

    Budapest, 1204, Hungary

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kagawa University Hospital

    Kagawa, Kita-gun, 761-0793, Japan

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Klinika Okulistyczna

    Bydgoszcz, 85-631, Poland

  • Kobe University Hospital

    Kobe, 650-0017, Japan

  • Long Island Vitreoretinal Consultants

    Great Neck, New York, 11021, United States

  • Lugene Eye Institute

    Glendale, California, 91204, United States

  • Maine Eye Center

    Portland, Maine, 04101, United States

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240, United States

  • Moorfields Eye Hospital

    London, EC1V 2PD, United Kingdom

  • NJRetina

    Teaneck, New Jersey, 07666, United States

  • Nara Medical University Hospital

    Kashihara, 634-8522, Japan

  • National Hospital Organization Tokyo Medical Center

    Meguro-ku, 152-8902, Japan

  • Nozologen Kft.

    Pécs, 7621, Hungary

  • Ospedale San Raffaele S.r.l.

    Milan, 20132, Italy

  • Ospedali Riuniti di Ancona

    Torrette Di Ancona, 60123, Italy

  • Retina Associates of Southern California

    Huntington Beach, California, 92647, United States

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107, United States

  • Retina Consultants Of Hawaii

    ‘Aiea, Hawaii, 96701, United States

  • Retina Consultants of Texas

    Katy, Texas, 77494, United States

  • Retina Consultants of Texas

    San Antonio, Texas, 78240, United States

  • Retina Consultants of Texas - Schertz

    Schertz, Texas, 78154, United States

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385, United States

  • Retina Research Center, PLLC

    Austin, Texas, 78705, United States

  • Retina Vitreous Surgeons of Central NY, PC

    Liverpool, New York, 13088, United States

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retinal Consultants Medical Group

    Sacramento, California, 95825, United States

  • Retinal Consultants Medical Group

    Sacramento, California, 95841, United States

  • Retinal Diagnostic Center

    Campbell, California, 95008, United States

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP, United Kingdom

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Semmelweis University

    Budapest, 1085, Hungary

  • Shinshu University Hospital

    Matsumoto-shi, 390-8621, Japan

  • Tennessee Retina

    Nashville, Tennessee, 37203, United States

  • The Retina Partners

    Encino, California, 91436, United States

  • Tokyo Medical University Hachioji Medical Center

    Hachioji-shi, 193-0998, Japan

  • University Debrecen Hospital

    Debrecen, 4032, Hungary

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Universitätsklinikum Bonn AöR

    Bonn, 53127, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89075, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131, Germany

  • Valley Retina Institute, PA

    McAllen, Texas, 78503, United States

  • Warsaw Ophthalmology Hospital

    Warsaw, 01-258, Poland

  • Western Eye Hospital

    London, NW1 5QH, United Kingdom

  • Zala Megyei Szent Rafael Korhaz

    Zala, 8900, Hungary

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