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

Status: Recruiting
Location: See all (89) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of DM under regular treatment with Haemoglobin A1c (HbA1c) (glycated haemoglobin) (HbA1c) \<12%

• Age ≥18 years at time of signing Informed Consent Form

⁃ Ocular inclusion criteria: study eye

• 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

• Presence of retinal non-perfusion (RNP) as assessed by ultra-widefield fluorescein angiography (UWF-FA) defined as an area ≥12.5 square millimeter (mm²) (approximately ≥5 disc areas) within a circular area with a 17.5 millimeter (mm) radius centred to the fovea 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

• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

Locations
United States
Arizona
Associated Retina Consultants, Ltd.
RECRUITING
Phoenix
California
California Retina Consultants-Bakersfield-65523
RECRUITING
Bakersfield
Retina-Vitreous Associates Medical Group
RECRUITING
Beverly Hills
Retinal Diagnostic Center
RECRUITING
Campbell
The Retina Partners
NOT_YET_RECRUITING
Encino
Lugene Eye Institute
RECRUITING
Glendale
Retina Associates of Southern California
RECRUITING
Huntington Beach
Byers Eye Institute
NOT_YET_RECRUITING
Palo Alto
California Eye Specialists Medical Group Inc
RECRUITING
Pasadena
Retinal Consultants Medical Group
RECRUITING
Sacramento
Retinal Consultants Medical Group
RECRUITING
Sacramento
California Retina Consultants-Santa Maria-65510
RECRUITING
Santa Maria
Bay Area Retina Associates - Walnut Creek
RECRUITING
Walnut Creek
Colorado
Colorado Retina Associates
NOT_YET_RECRUITING
Lakewood
Connecticut
Retina Group of New England, PC
RECRUITING
Waterford
Florida
Florida Retina Institute
RECRUITING
Jacksonville
Florida Retina Consultants
RECRUITING
Lakeland
Retina Vitreous Associates of Florida
NOT_YET_RECRUITING
St. Petersburg
East Florida Eye Institute
RECRUITING
Stuart
Center for Retina and Macular Disease
RECRUITING
Winter Haven
Hawaii
Retina Consultants Of Hawaii
RECRUITING
‘aiea
Maine
Maine Eye Center
NOT_YET_RECRUITING
Portland
Mississippi
Deep Blue Retina Clinical Research PLLC
RECRUITING
Southaven
New Jersey
NJRetina
RECRUITING
Teaneck
New York
Long Island Vitreoretinal Consultants
NOT_YET_RECRUITING
Great Neck
Retina Vitreous Surgeons of Central NY, PC
NOT_YET_RECRUITING
Liverpool
Ohio
University Hospitals of Cleveland
RECRUITING
Cleveland
Oregon
EyeHealth Northwest
RECRUITING
Portland
South Carolina
Charleston Neuroscience Institute - Ladson
RECRUITING
Ladson
Tennessee
Tennessee Retina
RECRUITING
Nashville
Texas
Austin Clinical Research, LLC
RECRUITING
Austin
Austin Retina Associates
RECRUITING
Austin
Retina Research Center, PLLC
RECRUITING
Austin
Valley Retina Institute, PA
RECRUITING
Mcallen
Austin Retina Associates
NOT_YET_RECRUITING
Round Rock
Medical Center Ophthalmology Associates
RECRUITING
San Antonio
Retinal Consultants of San Antonio
RECRUITING
San Antonio
Retina Consultants Of Texas
NOT_YET_RECRUITING
Schertz
Retina Consultants of Houston, PA-The Woodlands-66484
RECRUITING
The Woodlands
Utah
Retina Associates of Utah
RECRUITING
Salt Lake City
Other Locations
Germany
Universitätsklinikum Bonn AöR
NOT_YET_RECRUITING
Bonn
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
NOT_YET_RECRUITING
Mainz
Dietrich-Bonhoeffer-Klinikum
RECRUITING
Neubrandenburg
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Universitätsklinikum Ulm
RECRUITING
Ulm
Hungary
Budapest Retina Associations Kft.
RECRUITING
Budapest
Jahn Ferenc Del-Pest Hospital
RECRUITING
Budapest
Semmelweis University
RECRUITING
Budapest
University Debrecen Hospital
NOT_YET_RECRUITING
Debrecen
Nozologen Kft.
NOT_YET_RECRUITING
Pécs
Zala Megyei Szent Rafael Korhaz
RECRUITING
Zala
Italy
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Campobasso
Azienda Ospedaliera Careggi
RECRUITING
Florence
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
IRCCS San Raffaele
RECRUITING
Milan
IRCCS Fondazione Bietti
NOT_YET_RECRUITING
Roma
Istituto Clinico Humanitas
NOT_YET_RECRUITING
Rozzano
Ospedali Riuniti di Ancona
RECRUITING
Torrette Di Ancona
Japan
Akita University Hospital
NOT_YET_RECRUITING
Akita
Hyogo Prefectural Amagasaki General Medical Center
RECRUITING
Amagasaki-shi
Hayashi Eye Hospital
RECRUITING
Fukuoka
Fukushima Medical University Hospital
RECRUITING
Fukushima
Tokyo Medical University Hachioji Medical Center
RECRUITING
Hachioji-shi
Kagawa University Hospital
NOT_YET_RECRUITING
Kagawa, Kita-gun
Kagoshima University Hospital
NOT_YET_RECRUITING
Kagoshima
Nara Medical University Hospital
RECRUITING
Kashihara
Kobe University Hospital
RECRUITING
Kobe
Shinshu University Hospital
RECRUITING
Matsumoto-shi
National Hospital Organization Tokyo Medical Center
NOT_YET_RECRUITING
Meguro-ku
Aichi Medical University Hospital
NOT_YET_RECRUITING
Nagakute
Hyogo College of Medicine Hospital
NOT_YET_RECRUITING
Nishinomiya
Juntendo University Hospital
RECRUITING
Tokyo, Bunkyo-ku
Poland
Klinika Okulistyczna
RECRUITING
Bydgoszcz
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
RECRUITING
Olsztyn
Centrum Medyczne Piasta 47 sp. z o.o.
RECRUITING
Wałbrzych
Warsaw Ophthalmology Hospital
RECRUITING
Warsaw
4. Military Clinical Hospital with Polyclinic SP ZOZ
NOT_YET_RECRUITING
Wroclaw
Puerto Rico
Emanuelli Research & Development Center
RECRUITING
Arecibo
Spain
University Hospital of Bellvitge
RECRUITING
Barcelona
Hospital Clínico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitari General de Catalunya
RECRUITING
Sant Cugat Del Vallés
Hospital General Universitario de Valencia
RECRUITING
Valencia
United Kingdom
East Suffolk and North Essex NHS Foundation Trust
NOT_YET_RECRUITING
Colchester
Royal Liverpool University Hospital
RECRUITING
Liverpool
King's College Hospital
NOT_YET_RECRUITING
London
Moorfields Eye Hospital
RECRUITING
London
Western Eye Hospital
RECRUITING
London
Royal Victoria Infirmary
NOT_YET_RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2026-11-11
Participants
Target number of participants: 178
Treatments
Experimental: BI 764524
BI 764524
Sham_comparator: Sham comparator to BI 764524
Sham comparator to BI 764524
Active_comparator: Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov