Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-16 @ 5:47 PM
Study NCT ID:
NCT06321302
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-03-14', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52', 'timeFrame': 'At baseline and at Week 52', 'description': '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.\n\nHere 10 means "No retinopathy" and 85 means "Advanced proliferative diabetic retinopathy, with posterior fundus obscured, or centre of macula detached".\n\nThus, a higher score means symptoms get worse.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of vision threatening complications (VTC)s in the study eye between baseline and Week 52', 'timeFrame': 'At baseline and at Week 52'}, {'measure': 'Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52', 'timeFrame': 'At baseline and at Week 52', 'description': 'The BCVA score is the number of letters read correctly by the patient.'}, {'measure': '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', 'timeFrame': 'At baseline and at Week 52', 'description': 'μm= micrometer'}, {'measure': 'Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52', 'timeFrame': 'At baseline and at Week 52', 'description': '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.\n\nHere 10 means "No retinopathy" and 85 means "Advanced proliferative diabetic retinopathy, with posterior fundus obscured, or centre of macula detached".\n\nThus, a higher score means symptoms get worse.'}, {'measure': 'Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52', 'timeFrame': 'At baseline and at Week 52'}, {'measure': 'Development of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52', 'timeFrame': 'At baseline and at Week 52'}, {'measure': 'Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS)', 'timeFrame': 'up to 72 weeks'}, {'measure': 'Occurrence of ocular AEs in the study eye between baseline and EOS', 'timeFrame': 'up to 72 weeks'}, {'measure': 'Occurrence of ocular AEs of special interest in the study eye between baseline and EOS', 'timeFrame': 'up to 72 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "General inclusion criteria\n\n* 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\n* Age ≥18 years at time of signing Informed Consent Form (ICF)\n\nOcular inclusion criteria: study eye\n\n* Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (Diabetic Retinopathy Severity Scale (DRSS) 47 to 53) based on early treatment diabetic retinopathy study (ETDRS) 7-field grading as confirmed by the central reading centre (CRC) at screening\n* Ultra-widefield fluorescein angiography (UWF-FA) image gradable for presence of retinal non-perfusion (RNP) as confirmed by the CRC at screening\n* 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\n* Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging\n\nMain exclusion criteria in study eye:\n\n\\- Evidence of active retinal neovascularisation (NV) on clinical exam and/or ultra-widefield colour fundus photography (UWF-CFP) within the ETDRS 7-field, confirmed by the CRC grading\n\nThe following are permitted if, based on the assessment of the investigator, do not require acute treatment:\n\n* Small neovascular lesions within the ETDRS 7-field that are detected only on UWF-FA, but not on clinical exam or colour fundus photography (CFP)\n* Neovascularisations outside of the ETDRS 7-field on ultra-widefield imaging\n\n * Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle\n * 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\n * 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.)\n * Previous treatment in the study eye for NPDR and/or diabetic macular edema (DME) with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) (including anti-VEGF/Ang2) or short acting corticosteroid drugs (e.g. triamcinolone) within 6 months prior to Day 1 or dexamethasone intravitreal drug delivery system (Ozurdex) within 12 months prior to Day 1 (referred to elsewhere as 'previous IVT treatment').\n * Any previous IVT treatment other than anti-VEGF, and steroids. Previous fluocinolone acetonide intravitreal implant (Iluvien) is not allowed\n * 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\n * Any concurrent or past ocular condition in the study eye which, in the judgement of the investigator, could:\n* 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)\n* 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)\n* 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)\n* 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"}, 'identificationModule': {'nctId': 'NCT06321302', 'briefTitle': 'A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'CRIMSON: A Multicentre, Randomised, Sham-controlled (and Active Controlled in the USA), Double-masked, 72-week Trial to Study the Safety, Tolerability, Pharmacokinetics, and Efficacy of 3 Dosing Regimens of Intravitreal BI 764524 in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '1436-0007'}, 'secondaryIdInfos': [{'id': '2023-508891-12-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1299-0915', 'type': 'REGISTRY', 'domain': 'Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 764524', 'description': 'BI 764524', 'interventionNames': ['Drug: BI 764524']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham comparator to BI 764524', 'description': 'Sham comparator to BI 764524', 'interventionNames': ['Drug: Sham comparator to BI 764524']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept (Eylea®) - US only', 'description': 'Aflibercept (Eylea®) - US only', 'interventionNames': ['Drug: Aflibercept (Eylea®) - US only']}], 'interventions': [{'name': 'BI 764524', 'type': 'DRUG', 'description': 'BI 764524', 'armGroupLabels': ['BI 764524']}, {'name': 'Sham comparator to BI 764524', 'type': 'DRUG', 'description': 'Sham comparator to BI 764524', 'armGroupLabels': ['Sham comparator to BI 764524']}, {'name': 'Aflibercept (Eylea®) - US only', 'type': 'DRUG', 'description': 'Aflibercept (Eylea®) - US only', 'armGroupLabels': ['Aflibercept (Eylea®) - US only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Associated Retina Consultants, Ltd.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'California Retina Consultants-Bakersfield-65523', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 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