A study to test whether BI 764524 helps people with an eye condition called diabetic retinopathy

JRCT ID: jRCT2071240025

Registered date:28/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-proliferative diabetic retinopathy
• Date of first enrollment: 02/08/2024
• Target sample size: 18
• Countries of recruitment: Germany,Japan,Spain,Japan,UK,Japan,Hungary,Japan,Italy,Japan,Poland,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Drug: BI 764524
Sham comparator to BI 764524

Outcome(s)

Primary Outcome

Occurrence of a >=2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52 [Time Frame: At baseline and 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.

Secondary Outcome

- Occurrence of vision threatening complications (VTCs) in the study eye between baseline and Week 52 [Time Frame: At baseline and at Week 52]
- Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52 [Time Frame: At baseline and at Week 52]
The BCVA score is the number of letters read correctly by the patient.
- Absolute change from baseline of central retinal thickness [micrometer ], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52 [Time Frame: At baseline and at Week 52]
- Occurrence of a >=2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52 [Time Frame: At baseline and 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.
- Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52 [Time Frame: At baseline and at Week 52]
- Occurrence of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52 [Time Frame: At baseline and at Week 52]
- Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS) [Time Frame: up to 72 weeks]
- Occurrence of ocular AEs in the study eye between baseline and EOS [Time Frame: up to 72 weeks]
- Occurrence of ocular AEs of special interest in the study eye between baseline and EOS [Time Frame: up to 72 weeks]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

General inclusion criteria
- Diagnosis of DM under regular treatment with Haemoglobin A1c (HbA1c) (glycated haemoglobin) <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 >=5disc 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

Exclude criteria

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 (men)/305 micrometer (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 Information

• Primary Sponsor: Karak Soma
• Secondary ID(s): NCT06321302