Clinical trial • Phase IV • Ophthalmology
BI 764524 for Diabetic retinopathy
Phase IV trial of BI 764524 for Diabetic retinopathy.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Diabetic retinopathy
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 08-10-2024
Trial design
Randomised, sham injection procedure (sham/placebo intravitreal procedure); no dose or schedule specified. an active comparator in the usa is mentioned in the title but not specified in the available records.-controlled Phase IV trial in Spain, Poland, Germany and others.
- Randomised
- Yes
- Comparator
- Sham Injection Procedure (sham/placebo intravitreal procedure); no dose or schedule specified. An active comparator in the USA is mentioned in the title but not specified in the available records.
- Target Sample Size
- 113
- Trial Duration For Participant
- 504
Eligibility
Recruits 113 No vulnerable population selected. Participants are adults (age ≥18). Consent is obtained from adult participants; no assent procedures are described..
- Vulnerable Population
- No vulnerable population selected. Participants are adults (age ≥18). Consent is obtained from adult participants; no assent procedures are described.
Inclusion criteria
- {"criterion_text":"- Male or female, age ≥18 years"}
- {"criterion_text":"- Diagnosis of diabetes mellitus (DM) under regular treatment with HbA1c <12%; DM should be under regular investigation by a trained specialist as per local standard of care prior to and during the trial"}
- {"criterion_text":"- Moderate to severe NPDR (DRSS level 43 to 53) as assessed by UWF-CFP images (within the 7 field grid) and confirmed by the CRC at screening."}
- {"criterion_text":"- Presence of RNP as assessed by ultra-widefield fluorescein angiography (UWF-FA) defined as ≥12.5 mm² (approximately ≥5 disc areas) within a circular area with a 17.5 mm radius centred to the fovea"}
- {"criterion_text":"- Visual acuity: BCVA ≥49 letters (ETDRS chart, 4 m distance)"}
- {"criterion_text":"- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging"}
Exclusion criteria
- {"criterion_text":"- Active retinal NV within 7 field grid"}
- {"criterion_text":"- Active NV of iris or in the anterior chamber angle"}
- {"criterion_text":"- Prior PRP"}
- {"criterion_text":"- CI-DME, defined as central subfield thickness (CST) ≥320 μm"}
- {"criterion_text":"- Previous treatment in the study eye for NPDR and/or DME with IVT anti-VEGF (including anti-VEGF/Ang2) or short acting corticosteroid drugs within 6 months prior to Day 1, or >4 treatments within the last 18 months"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Active ocular inflammation, aphakia or total absence of the posterior capsule, or uncontrolled glaucoma"}
- {"criterion_text":"- Refractive error <-8 dioptres"}
- {"criterion_text":"- Concurrent or past ocular conditions affecting trial results"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the occurrence of a ≥2 step improvement compared with baseline in DRSS level in the study eye at Week 52 as assessed by UWF-CFP images (within the 7-field grid).","definition_or_measurement_approach":"Response is defined as the proportion of patients with a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52; assessed by UWF-CFP images (within the 7-field grid). Treatment effect summarised as absolute differences in proportions between BI 764524 and sham."}
Secondary endpoints
- {"endpoint_text":"- The key secondary endpoint is the occurrence of VTCs, defined as PDR and/or anterior segment NV, or development of CI-DME, in the study eye between baseline and Week 52","definition_or_measurement_approach":"Occurrence of vision-threatening complications (VTCs: proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV), or development of central-involving diabetic macular edema (CI-DME)) between baseline and Week 52 in the study eye."}
- {"endpoint_text":"- Absolute change from baseline of BCVA [ETDRS letters] in the study eye at Week 52","definition_or_measurement_approach":"Measured as absolute change from baseline in Best Corrected Visual Acuity (BCVA) using ETDRS letter score at Week 52."}
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured as absolute change from baseline in central subfield thickness (CST) in micrometres assessed by spectral domain OCT (SD-OCT) at Week 52."}
- {"endpoint_text":"- Occurrence of a ≥2 step worsening of DRSS in the study eye between baseline and Week 52 as assessed by UWF-CFP images (within the 7-field grid)","definition_or_measurement_approach":"Assessed by UWF-CFP images (within the 7-field grid); occurrence of ≥2-step worsening in DRSS between baseline and Week 52 in study eye."}
- {"endpoint_text":"- Occurrence of PDR and/or anterior segment NV in the study eye between baseline and Week 52","definition_or_measurement_approach":"Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation in the study eye between baseline and Week 52."}
- {"endpoint_text":"- Occurrence of CI-DME in the study eye between baseline and Week 52","definition_or_measurement_approach":"Occurrence of central-involving diabetic macular oedema (CI-DME) in the study eye between baseline and Week 52."}
- {"endpoint_text":"- Occurrence of drug-related AEs between baseline and EOS","definition_or_measurement_approach":"Occurrence of adverse events considered drug-related between baseline and end of study (EOS)."}
- {"endpoint_text":"- Occurrence of ocular AEs in the study eye between baseline and EOS","definition_or_measurement_approach":"Occurrence of ocular adverse events in the study eye between baseline and EOS."}
- {"endpoint_text":"- Occurrence of ocular AEs of special interest in the study eye between baseline and EOS","definition_or_measurement_approach":"Occurrence of pre-specified ocular adverse events of special interest in the study eye between baseline and EOS."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 113
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent obtained from adult participants (age ≥18). Subject information and informed consent forms (L1_SIS and ICF) are provided; country-specific and topic-specific consent documents are available (e.g. country ICFs, pregnant participant form, biobanking/genetic consent). Documents/translations are present for multiple languages (English and country-specific materials evident for Spanish, German, Hungarian, Italian, Polish).
Methods
- Study website (K1_Recruitment Website) - public-facing recruitment website
- Posters (K1/K2 Recruitment Poster) - site and public posters
- Brochures (K1/K2 Recruitment Brochure) - printed recruitment brochure
- Pre-screener materials (K1_Recruitment Other Pre-Screener) - pre-screening questionnaires/tools
- Patient videos (K1_Recruitment Other Video / Patient Video) - informational recruitment videos
- Infogetters / other information sheets (K1/K2 Other Infogetter, Other Information Sheet) - informational materials for potential participants
- Recruitment adverts (K1/K2 Recruitment Other Advert) - general adverts to raise awareness
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 103
Spain
- Earliest CTIS Part Ii Submission Date
- 04-09-2024
- Latest Decision Or Authorization Date
- 21-01-2026
- Processing Time Days
- 504
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- ESP4: Oftalmologia
- Principal Investigator Name
- José Ignacio Fernández-Vigo Escribano
- Principal Investigator Email
- joseignacio.fernandez-vigo@salud.madrid.org
- Contact Person Name
- José Ignacio Fernández-Vigo Escribano
- Contact Person Email
- joseignacio.fernandez-vigo@salud.madrid.org
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- ESP2: Oftalmología
- Principal Investigator Name
- Enrique Cervera Taulet
- Principal Investigator Email
- cervera_enr@gva.es
- Contact Person Name
- Enrique Cervera Taulet
- Contact Person Email
- cervera_enr@gva.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- ESP3: Oftalmologia
- Principal Investigator Name
- Javier Sambricio García
- Principal Investigator Email
- javiersambricio@gmail.com
- Contact Person Name
- Javier Sambricio García
- Contact Person Email
- javiersambricio@gmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- ESP1: Oftalmología
- Principal Investigator Name
- Luis Arias Barquet
- Principal Investigator Email
- luisariasbarquet@gmail.com
- Contact Person Name
- Luis Arias Barquet
- Contact Person Email
- luisariasbarquet@gmail.com
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- ESP5: Oftalmología
- Principal Investigator Name
- Laura Sararols Ramsay
- Principal Investigator Email
- lsararols@omiq.es
- Contact Person Name
- Laura Sararols Ramsay
- Contact Person Email
- lsararols@omiq.es
Poland
- Earliest CTIS Part Ii Submission Date
- 06-09-2024
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 507
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Warszawski Szpital Okulistyczny Sp. z o.o.
- Department Name
- POL5: Opthalmology
- Principal Investigator Name
- Agnieszka Nowosielska
- Principal Investigator Email
- nowosielska.aga@gmail.com
- Contact Person Name
- Agnieszka Nowosielska
- Contact Person Email
- nowosielska.aga@gmail.com
- Site Name
- Oftalmika Sp. z o.o.
- Department Name
- POL2: Opthalmology
- Principal Investigator Name
- Bartlomiej Kaluzny
- Principal Investigator Email
- bartka@by.onet.pl
- Contact Person Name
- Bartlomiej Kaluzny
- Contact Person Email
- bartka@by.onet.pl
- Site Name
- Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
- Department Name
- POL1: Opthalmology
- Principal Investigator Name
- Dominik Zalewski
- Principal Investigator Email
- domizal@gmail.com
- Contact Person Name
- Dominik Zalewski
- Contact Person Email
- domizal@gmail.com
- Site Name
- Centrum Medyczne Piasta 47 Sp. z o.o.
- Department Name
- POL4: Opthalmology
- Principal Investigator Name
- Ewa Fluder
- Principal Investigator Email
- jevick76@gmail.com
- Contact Person Name
- Ewa Fluder
- Contact Person Email
- jevick76@gmail.com
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Polikliniką Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Department Name
- POL3: Opthalmology
- Principal Investigator Name
- Robert Leszek
- Principal Investigator Email
- okulistyka@4wsk.pl
- Contact Person Name
- Robert Leszek
- Contact Person Email
- okulistyka@4wsk.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 06-09-2024
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 504
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- DEU2: Ophthalmology
- Principal Investigator Name
- Jonas Neubauer
- Principal Investigator Email
- Jonas.Neubauer@med.uni-tuebingen.de
- Contact Person Name
- Jonas Neubauer
- Contact Person Email
- Jonas.Neubauer@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- DEU3: Augenklinik
- Principal Investigator Name
- Armin Wolf
- Principal Investigator Email
- Armin.Wolf@uniklinik-ulm.de
- Contact Person Name
- Armin Wolf
- Contact Person Email
- Armin.Wolf@uniklinik-ulm.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- DEU4: Augenklinik und Poliklinik
- Principal Investigator Name
- Katrin Lorenz
- Principal Investigator Email
- katrin.lorenz@unimedizin-mainz.de
- Contact Person Name
- Katrin Lorenz
- Contact Person Email
- katrin.lorenz@unimedizin-mainz.de
- Site Name
- Diakonie Klinikum Dietrich Bonhoeffer GmbH
- Department Name
- DEU1: Augenheilkunde
- Principal Investigator Name
- Christian Brinkmann
- Principal Investigator Email
- BrinkmannC@dbknb.de
- Contact Person Name
- Christian Brinkmann
- Contact Person Email
- BrinkmannC@dbknb.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- DEU5: Augenklinik
- Principal Investigator Name
- Kristina Pfau
- Principal Investigator Email
- Kristina.Pfau@ukbonn.de
- Contact Person Name
- Kristina Pfau
- Contact Person Email
- Kristina.Pfau@ukbonn.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 581
- Number Of Sites
- 7
- Number Of Participants
- 15
Sites
- Site Name
- Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
- Department Name
- HUN3: Szemészeti Osztály
- Principal Investigator Name
- Norbert CZUMBEL
- Principal Investigator Email
- czumbel@gmail.com
- Contact Person Name
- Norbert CZUMBEL
- Contact Person Email
- czumbel@gmail.com
- Site Name
- Zala Varmegyei Szent Rafael Korhaz
- Department Name
- HUN4: Szemészeti Osztály
- Principal Investigator Name
- Katalin KISS
- Principal Investigator Email
- rezikiss@t-online.hu
- Contact Person Name
- Katalin KISS
- Contact Person Email
- rezikiss@t-online.hu
- Site Name
- Semmelweis University
- Department Name
- HUN7: Szemészeti Klinika
- Principal Investigator Name
- András PAPP
- Principal Investigator Email
- andras.papp.md@gmail.com
- Contact Person Name
- András PAPP
- Contact Person Email
- andras.papp.md@gmail.com
- Site Name
- Nozologen Kft.
- Department Name
- HUN5: NAP
- Principal Investigator Name
- Balázs VARSÁNYI
- Principal Investigator Email
- varsanyi.balazs@ganglion.hu
- Contact Person Name
- Balázs VARSÁNYI
- Contact Person Email
- varsanyi.balazs@ganglion.hu
- Site Name
- Budapest Retina Associates Kft.
- Department Name
- HUN6: NAP
- Principal Investigator Name
- András SERES
- Principal Investigator Email
- seres@budapestretina.hu
- Contact Person Name
- András SERES
- Contact Person Email
- seres@budapestretina.hu
- Site Name
- University Of Debrecen
- Department Name
- HUN1: Szemklinika
- Principal Investigator Name
- Attila VAJAS
- Principal Investigator Email
- vajasa@gmail.com
- Contact Person Name
- Attila VAJAS
- Contact Person Email
- vajasa@gmail.com
- Site Name
- Nozologen Kft.
- Department Name
- HUN5: NAP
- Principal Investigator Name
- Balázs VARSÁNYI
- Principal Investigator Email
- varsanyi.balazs@ganglion.hu
- Contact Person Name
- Balázs VARSÁNYI
- Contact Person Email
- varsanyi.balazs@ganglion.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 05-09-2024
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 505
- Number Of Sites
- 7
- Number Of Participants
- 32
Sites
- Site Name
- Instituto Di Ricovero E Cura A Carattere Scientifico
- Department Name
- #ITA7:Divisione di Retina Medica
- Principal Investigator Name
- Monica Varano
- Principal Investigator Email
- monica.varano@fondazionebietti.it
- Contact Person Name
- Monica Varano
- Contact Person Email
- monica.varano@fondazionebietti.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- #ITA1:SC di Oculistica
- Principal Investigator Name
- Francesco Viola
- Principal Investigator Email
- francesco.viola@unimi.it
- Contact Person Name
- Francesco Viola
- Contact Person Email
- francesco.viola@unimi.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- #ITA4:SOD Clinica Oculistica
- Principal Investigator Name
- Marco Lupidi
- Principal Investigator Email
- marcomed2@gmail.com
- Contact Person Name
- Marco Lupidi
- Contact Person Email
- marcomed2@gmail.com
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- #ITA2:U.O. Oculistica
- Principal Investigator Name
- Jose Luis Vallejo Garcia
- Principal Investigator Email
- jose_luis.vallejo_garcia@humanitas.it
- Contact Person Name
- Jose Luis Vallejo Garcia
- Contact Person Email
- jose_luis.vallejo_garcia@humanitas.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- #ITA3:Unità di oculistica
- Principal Investigator Name
- Francesco Bandello
- Principal Investigator Email
- bandello.francesco@hsr.it
- Contact Person Name
- Francesco Bandello
- Contact Person Email
- bandello.francesco@hsr.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- #ITA5:UOC Oftalmologia
- Principal Investigator Name
- Ciro Costagliola
- Principal Investigator Email
- ciro.costagliola@unina.it
- Contact Person Name
- Ciro Costagliola
- Contact Person Email
- ciro.costagliola@unina.it
- Site Name
- Careggi University Hospital
- Department Name
- #ITA6:Ottica Fisiopatologica-SOD Oculistica
- Principal Investigator Name
- Gianni Virgili
- Principal Investigator Email
- gianni.virgili@unifi.it
- Contact Person Name
- Gianni Virgili
- Contact Person Email
- gianni.virgili@unifi.it
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Third parties
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"24/7 Medical Emergency Call Centre Support","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"Optical Equipment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"CluePoints INC","duties_or_roles":"Data Surveillance","organisation_type":"Industry"}
- {"country":"Spain","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Pre-screen Navigator","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BI 764524
- Active Substance
- BI 764524
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intravitreal
- Route
- Intravitreal
- Authorisation Status
- Investigational (authorisation status not specified)
- Investigational Product Name
- Sham Injection Procedure
- Modality
- Other
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