Diabetic RetinopathyPhase 2NCT06321302
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
A Phase 2 study testing BI 764524 and Aflibercept (Eylea®) - US only in people with Diabetic Retinopathy, run by Boehringer Ingelheim at 90 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- BI 764524 and Aflibercept (Eylea®) - US only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 90 sitesin 9 countries
- Study dates
- 15 May 2024to 20 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
90 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
90 sites in 9 countries
United States40 sites, 2 recruiting
- Active, not recruiting
Retina Consultants Of Hawaii
‘Aiea, Hawaii, 96701
- Active, not recruiting
Austin Retina Associates
Austin, Texas, 78705
- Active, not recruiting
Retina Research Center, PLLC
Austin, Texas, 78705
- Active, not recruiting
Austin Clinical Research, LLC
Austin, Texas, 78750
- Active, not recruiting
California Retina Consultants-Bakersfield-65523
Bakersfield, California, 93309
- Active, not recruiting
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
- Completed
Retinal Diagnostic Center
Campbell, California, 95008
- Active, not recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Active, not recruiting
The Retina Partners
Encino, California, 91436
- Active, not recruiting
Lugene Eye Institute
Glendale, California, 91204
- Completed
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021
- Active, not recruiting
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
- Active, not recruiting
Retina Associates of Southern California
Huntington Beach, California, 92647
- Recruiting
Florida Retina Institute
Jacksonville, Florida, 32216
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Active, not recruiting
Retina Consultants of Texas
Katy, Texas, 77494
- Completed
Charleston Neuroscience Institute - Ladson
Ladson, South Carolina, 29456
- Active, not recruiting
Florida Retina Consultants
Lakeland, Florida, 33805
- Active, not recruiting
Colorado Retina Associates
Lakewood, Colorado, 80228
- Active, not recruiting
Retina Vitreous Surgeons of Central NY, PC
Liverpool, New York, 13088
- Completed
Valley Retina Institute, PA
McAllen, Texas, 78503
- Active, not recruiting
Tennessee Retina
Nashville, Tennessee, 37203
- Completed
Byers Eye Institute
Palo Alto, California, 94303
- Active, not recruiting
California Eye Specialists Medical Group Inc
Pasadena, California, 91107
- Active, not recruiting
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020
- Active, not recruiting
Maine Eye Center
Portland, Maine, 04101
- Completed
EyeHealth Northwest
Portland, Oregon, 97225
- Completed
Austin Retina Associates
Round Rock, Texas, 78681
- Active, not recruiting
Retinal Consultants Medical Group
Sacramento, California, 95825
- Active, not recruiting
Retinal Consultants Medical Group
Sacramento, California, 95841
- Recruiting
Retina Associates of Utah
Salt Lake City, Utah, 84107
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Active, not recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
- Active, not recruiting
Retina Consultants of Texas
San Antonio, Texas, 78240
- Active, not recruiting
California Retina Consultants-Santa Maria-65510
Santa Maria, California, 93454
- Completed
Retina Consultants of Texas - Schertz
Schertz, Texas, 78154
- Active, not recruiting
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi, 38671
- Active, not recruiting
East Florida Eye Institute
Stuart, Florida, 34994
- Active, not recruiting
NJRetina
Teaneck, New Jersey, 07666
- Active, not recruiting
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, 94598
- Completed
Retina Group of New England, PC
Waterford, Connecticut, 06385
- Active, not recruiting
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
Japan14 sites
- Completed
Akita University Hospital
Akita, 010-8543
- Active, not recruiting
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki-shi, 660-8550
- Active, not recruiting
Hayashi Eye Hospital
Fukuoka, 812-0011
- Active, not recruiting
Fukushima Medical University Hospital
Fukushima, 960-1295
- Active, not recruiting
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, 193-0998
- Completed
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793
- Completed
Kagoshima University Hospital
Kagoshima, 890-8520
- Completed
Nara Medical University Hospital
Kashihara, 634-8522
- Completed
Kobe University Hospital
Kobe, 650-0017
- Active, not recruiting
Shinshu University Hospital
Matsumoto-shi, 390-8621
- Active, not recruiting
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152-8902
- Completed
Aichi Medical University Hospital
Nagakute, 480-1195
- Active, not recruiting
Hyogo College of Medicine Hospital
Nishinomiya, 663-8501
- Active, not recruiting
Juntendo University Hospital
Tokyo, 113-8431
Italy7 sites
- Active, not recruiting
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
- Active, not recruiting
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122
- Completed
Ospedale San Raffaele S.r.l.
Milan, 20132
- Active, not recruiting
Azienda Ospedaliera Universitaria "Federico II"
Naples, 80131
- Completed
IRCCS Fondazione Bietti
Roma, 00198
- Active, not recruiting
Istituto Clinico Humanitas
Rozzano, 20089
- Active, not recruiting
Ospedali Riuniti di Ancona
Torrette Di Ancona, 60123
United Kingdom7 sites
- Completed
Colchester Hospital
Colchester, CO4 5JL
- Active, not recruiting
Royal Liverpool University Hospital
Liverpool, L7 8XP
- Active, not recruiting
Moorfields Eye Hospital
London, EC1V 2PD
- Active, not recruiting
Western Eye Hospital
London, NW1 5QH
- Completed
King's College Hospital
London, SE5 9RS
- Active, not recruiting
Central Middlesex Hospital
London
- Active, not recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Hungary6 sites
- Completed
Semmelweis University
Budapest, 1085
- Active, not recruiting
Budapest Retina Associations Kft.
Budapest, 1133
- Completed
Jahn Ferenc Del-Pest Hospital
Budapest, 1204
- Completed
University Debrecen Hospital
Debrecen, 4032
- Active, not recruiting
Nozologen Kft.
Pécs, 7621
- Active, not recruiting
Zala Megyei Szent Rafael Korhaz
Zala, 8900
Germany5 sites
- Completed
Universitätsklinikum Bonn AöR
Bonn, 53127
- Active, not recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
- Completed
Diakonie Klinikum Dietrich Bonhoeffer GmbH
Neubrandenburg, 17036
- Completed
Universitätsklinikum Tübingen
Tübingen, 72076
- Completed
Universitätsklinikum Ulm
Ulm, 89075
Poland5 sites
- Completed
Klinika Okulistyczna
Bydgoszcz, 85-631
- Active, not recruiting
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, 10-424
- Completed
Centrum Medyczne Piasta 47 sp. z o.o.
Wałbrzych, 58-304
- Active, not recruiting
Warsaw Ophthalmology Hospital
Warsaw, 01-258
- Completed
4. Military Clinical Hospital with Polyclinic SP ZOZ
Wroclaw, 50-981
Spain5 sites
- Completed
Hospital Universitari de Bellvitge
Barcelon, 08907
- Completed
Hospital Clínico San Carlos
Madrid, 28040
- Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Active, not recruiting
Hospital Universitari General de Catalunya
Sant Cugat Del Vallés, 08195
- Active, not recruiting
Hospital General Universitario de Valencia
Valencia, 46014
Puerto Rico1 site
- Active, not recruiting
Emanuelli Research & Development Center
Arecibo, 00612
About this study
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 Moderate to Severe Non-proliferative Diabetic Retinopathy
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
- Being tested
- BI 764524, Sham comparator to BI 764524, Aflibercept (Eylea®) - US only
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 764524Drug
BI 764524
Sham comparator to BI 764524Drug
Sham comparator to BI 764524
Aflibercept (Eylea®) - US onlyDrug
Aflibercept (Eylea®) - US only
| Study group | Role | What they receive |
|---|---|---|
| BI 764524 | Experimental | BI 764524 Receives: Drug: BI 764524 |
| Sham comparator to BI 764524 | Sham comparator | Sham comparator to BI 764524 Receives: Drug: Sham comparator to BI 764524 |
| Aflibercept (Eylea®) - US only | Active comparator | Aflibercept (Eylea®) - US only Receives: Drug: Aflibercept (Eylea®) - US only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
The BCVA score is the number of letters read correctly by the patient.
Measured: 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
μm= micrometer
Measured: 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)
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.
Measured: 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
Measured: At baseline and at Week 52
Development of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52
Measured: At baseline and at Week 52
Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS)
Measured: up to 72 weeks
Occurrence of ocular AEs in the study eye between baseline and EOS
Measured: up to 72 weeks
Occurrence of ocular AEs of special interest in the study eye between baseline and EOS
Measured: up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 May 2024
- Primary completion5 Mar 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321302
- Sponsor's protocol ID
- 1436-0007
- Other IDs
- 2023-508891-12-00, U1111-1299-0915, 2023
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Moderate to Severe Non-proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06321302
- Acronym / sponsor ID
- 1436-0007
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 764524 | Experimental | Drug: BI 764524BI 764524 |
| Sham comparator to BI 764524 | Sham comparator | Drug: Sham comparator to BI 764524Sham comparator to BI 764524 |
| Aflibercept (Eylea®) - US only | Active comparator | Drug: Aflibercept (Eylea®) - US onlyAflibercept (Eylea®) - US only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 764524BI 764524 | Drug | BI 764524 |
| Sham comparator to BI 764524Sham comparator to BI 764524 | Drug | Sham comparator to BI 764524 |
| Aflibercept (Eylea®) - US onlyAflibercept (Eylea®) - US only | Drug | Aflibercept (Eylea®) - US only |
Primary outcome
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)
Time frame: 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.
9 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: At baseline and at Week 52
Development of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52
Time frame: At baseline and at Week 52
Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS)
Time frame: up to 72 weeks
Occurrence of ocular AEs in the study eye between baseline and EOS
Time frame: up to 72 weeks
Occurrence of ocular AEs of special interest in the study eye between baseline and EOS
Time frame: up to 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
90 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 764524 and Aflibercept (Eylea®) - US only in people with Diabetic Retinopathy, run by Boehringer Ingelheim at 90 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, Japan, Italy, United Kingdom, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: At baseline and at Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.