Retinal Consultants Medical Group | Greenback Lane, Sacramento, CA
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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.
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Inclusion and exclusion criteria
General inclusion criteria
Ocular inclusion criteria: study eye
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:
Primary purpose
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178 participants in 3 patient groups
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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