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

Diabetic Retinopathy Clinical Trial

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 Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321302
• Other study ID #: 1436-0007
• Secondary ID: 2023-508891-12-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 8, 2024
• Est. completion date: November 11, 2026

Study information

• Verified date: March 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: November 11, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General inclusion criteria

• 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

Main exclusion criteria in study eye:

• 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 -- Neovascularisations outside of the ETDRS 7-field on ultra-widefield imaging may be included if this condition, based on the assessment of the investigator, does not require acute treatment
• 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) (defined as =100 burns placed previously outside of the posterior pole)
• CI-DME, defined as a central subfield thickness (CST) =320 micrometer (µm) (men)/305 µm (women), measured by Heidelberg Spectralis optical coherence tomography (OCT)), in the study eye as confirmed by the CRC at screening
• 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) drugs within 6 months prior to Day 1. The number of patients with history of an IVT anti-VEGF treatment is limited to approximately 50 randomised patients. Once this number has been achieved, any patients with previous IVT treatment will be excluded
• Any previous IVT treatment other than anti-VEGF, including steroids
• Myopia with a refractive error <-8 dioptres (spherical equivalent) in the study eye. For patients having undergone refractive or cataract surgery in the study eye, the preoperative refractive error should be used.
• 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/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol); history of central serous chorioretinopathy, ischemic optic neuropathy or retinal vascular occlusion

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• BI 764524
BI 764524
• Sham comparator to BI 764524
Sham comparator to BI 764524
• Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a =2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye 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	Occurrence of vision threatening complications (VTC)s in the study eye between baseline and Week 52		At baseline and at Week 52
Secondary	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.	At baseline and at Week 52
Secondary	Absolute change from baseline of central retinal thickness [µm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52	µm= micrometer	At baseline and at Week 52
Secondary	Occurrence of a =2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and 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	Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52		At baseline and at Week 52
Secondary	Occurrence of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52		At baseline and at Week 52
Secondary	Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS)		up to 72 weeks
Secondary	Occurrence of ocular AEs in the study eye between baseline and EOS		up to 72 weeks
Secondary	Occurrence of ocular AEs of special interest in the study eye between baseline and EOS		up to 72 weeks

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