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

Boehringer Ingelheim

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Retinopathy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06321302

2023-508891-12-00 (Registry Identifier)

U1111-1299-0915 (Registry Identifier)

1436-0007

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

• 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, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 3 patient groups

BI 764524

Experimental group

Description:

BI 764524

Treatment:

Drug: BI 764524

Sham comparator to BI 764524

Sham Comparator group

Description:

Sham comparator to BI 764524

Treatment:

Drug: Sham comparator to BI 764524

Aflibercept (Eylea®) - US only

Active Comparator group

Description:

Aflibercept (Eylea®) - US only

Treatment:

Drug: Aflibercept (Eylea®) - US only