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A study to test whether BI 764524 helps people with an eye condition called diabetic retinopathy
EU CTIS ID: 2023-508891-12-00
What this study is testing
The primary objective is to demonstrate a non-flat dosing frequency-response curve and then to evaluate the dosing frequency-response relationship for BI 764524. For this purpose, the response is defined as the proportion of patients with a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52. The treatment effect is summarised as the absolute differences in proportions between BI 764524 and sham.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, age ≥18 years
- Diagnosis of diabetes mellitus (DM) under regular treatment with HbA1c <12%; DM should be under regular investigation by a trained specialist as per local standard of care prior to and during the trial
- Moderate to severe NPDR (DRSS level 43 to 53) as assessed by UWF-CFP images (within the 7 field grid) and confirmed by the CRC at screening.
- Presence of RNP as assessed by ultra-widefield fluorescein angiography (UWF-FA) defined as ≥12.5 mm² (approximately ≥5 disc areas) within a circular area with a 17.5 mm radius centred to the fovea
- Visual acuity: BCVA ≥49 letters (ETDRS chart, 4 m distance)
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
You likely can't join if
- Active retinal NV within 7 field grid
- Active NV of iris or in the anterior chamber angle
- Prior PRP
- CI-DME, defined as central subfield thickness (CST) ≥320 μm
- Previous treatment in the study eye for NPDR and/or DME with IVT anti-VEGF (including anti-VEGF/Ang2) or short acting corticosteroid drugs within 6 months prior to Day 1, or >4 treatments within the last 18 months
- Any previous IVT treatment other than anti-VEGF, and short-acting steroids. Previous dexamethasone IVT drug delivery system (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) is not allowed
See the full eligibility criteria
- Male or female, age ≥18 years
- Diagnosis of diabetes mellitus (DM) under regular treatment with HbA1c <12%; DM should be under regular investigation by a trained specialist as per local standard of care prior to and during the trial
- Moderate to severe NPDR (DRSS level 43 to 53) as assessed by UWF-CFP images (within the 7 field grid) and confirmed by the CRC at screening.
- Presence of RNP as assessed by ultra-widefield fluorescein angiography (UWF-FA) defined as ≥12.5 mm² (approximately ≥5 disc areas) within a circular area with a 17.5 mm radius centred to the fovea
- Visual acuity: BCVA ≥49 letters (ETDRS chart, 4 m distance)
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
- Active retinal NV within 7 field grid
- Active NV of iris or in the anterior chamber angle
- Prior PRP
- CI-DME, defined as central subfield thickness (CST) ≥320 μm
- Previous treatment in the study eye for NPDR and/or DME with IVT anti-VEGF (including anti-VEGF/Ang2) or short acting corticosteroid drugs within 6 months prior to Day 1, or >4 treatments within the last 18 months
- Any previous IVT treatment other than anti-VEGF, and short-acting steroids. Previous dexamethasone IVT drug delivery system (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) is not allowed
- Active ocular inflammation, aphakia or total absence of the posterior capsule, or uncontrolled glaucoma
- Refractive error <-8 dioptres
- Concurrent or past ocular conditions affecting trial results
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Japan
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.