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

May 31, 2026 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn AöR
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Neubrandenburg, Germany, 17036
        • Diakonie Klinikum Dietrich Bonhoeffer GmbH
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89075
        • Universitatsklinikum Ulm
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University
      • Budapest, Hungary, 1204
        • Jahn Ferenc Del-Pest Hospital
      • Budapest, Hungary, 1133
        • Budapest Retina Associations Kft.
      • Debrecen, Hungary, 4032
        • University Debrecen Hospital
      • Pécs, Hungary, 7621
        • Nozologen Kft.
      • Zala, Hungary, 8900
        • Zala Megyei Szent Rafael Korhaz
  • Italy
      • Florence, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi
      • Milan, Italy, 20132
        • Ospedale San Raffaele S.r.l.
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torrette Di Ancona, Italy, 60123
        • Ospedali Riuniti di Ancona
  • Japan
      • Akita, Japan, 010-8543
        • Akita University Hospital
      • Amagasaki-shi, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
      • Fukuoka, Japan, 812-0011
        • Hayashi Eye Hospital
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Hachioji-shi, Japan, 193-0998
        • Tokyo Medical University Hachioji Medical Center
      • Kagawa, Kita-gun, Japan, 761-0793
        • Kagawa University Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kashihara, Japan, 634-8522
        • Nara Medical University Hospital
      • Kobe, Japan, 650-0017
        • Kobe University Hospital
      • Matsumoto-shi, Japan, 390-8621
        • Shinshu University Hospital
      • Meguro-ku, Japan, 152-8902
        • National Hospital Organization Tokyo Medical Center
      • Nagakute, Japan, 480-1195
        • Aichi Medical University Hospital
      • Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine Hospital
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
  • Poland
      • Bydgoszcz, Poland, 85-631
        • Klinika Okulistyczna
      • Olsztyn, Poland, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
      • Warsaw, Poland, 01-258
        • Warsaw Ophthalmology Hospital
      • Wałbrzych, Poland, 58-304
        • Centrum Medyczne Piasta 47 sp. z o.o.
      • Wroclaw, Poland, 50-981
        • 4. Military Clinical Hospital with Polyclinic SP ZOZ
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research & Development Center
  • Spain
      • Barcelon, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Sant Cugat Del Vallés, Spain, 08195
        • Hospital Universitari General de Catalunya
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
  • United Kingdom
      • Colchester, United Kingdom, CO4 5JL
        • Colchester Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
      • London, United Kingdom, NW1 5QH
        • Western Eye Hospital
      • London, United Kingdom
        • Central Middlesex Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants, Ltd.
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants-Bakersfield-65523
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Encino, California, United States, 91436
        • The Retina Partners
      • Glendale, California, United States, 91204
        • Lugene Eye Institute
      • Huntington Beach, California, United States, 92647
        • Retina Associates of Southern California
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group Inc
      • Sacramento, California, United States, 95841
        • Retinal Consultants Medical Group
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group
      • Santa Maria, California, United States, 93454
        • California Retina Consultants-Santa Maria-65510
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates - Walnut Creek
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England, PC
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Florida Retina Institute
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Eye Center
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Deep Blue Retina Clinical Research PLLC
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • NJRetina
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Vitreoretinal Consultants
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of Central NY, PC
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • EyeHealth Northwest
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute - Ladson
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina
    • Texas
      • Austin, Texas, United States, 78705
        • Retina Research Center, PLLC
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Austin, Texas, United States, 78750
        • Austin Clinical Research, LLC
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
      • Round Rock, Texas, United States, 78681
        • Austin Retina Associates
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas
      • Schertz, Texas, United States, 78154
        • Retina Consultants of Texas - Schertz
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BI 764524
Drug: BI 764524
BI 764524
Sham Comparator: Sham comparator to BI 764524
Drug: Sham comparator to BI 764524
Sham comparator to BI 764524
Active Comparator: Aflibercept (Eylea®) - US only
Drug: Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and at Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The BCVA score is the number of letters read correctly by the patient.
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
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
up to 72 weeks
Occurrence of ocular AEs in the study eye between baseline and EOS
Time Frame: up to 72 weeks
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
up to 72 weeks
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
μm= micrometer
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
At baseline and at Week 52
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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1436-0007
  • 2023-508891-12-00 (Registry Identifier: CTIS)
  • U1111-1299-0915 (Registry Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Retinopathy

Clinical Trials on BI 764524

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings