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A study to test whether BI 1815368 helps people with an eye condition called diabetic macular edema
EU CTIS ID: 2024-520384-14-00
What this study is testing
Evaluate the dose-response relationship for BI 1815368 in participants with varying levels of vision impairment due to CI-DME
- 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
- ≥18 years of age
- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), HbA1c <12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
- CI-DME confirmed on SD-OCT with CST ≥320 µm in the study eye at screening
- BCVA visual acuity ETDRS letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening
- Further inclusion criteria apply
You likely can't join if
- Macular edema considered to be due to other causes than CI-DME in the study eye
- Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
- Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8 mg), and within 6 months before Day 1 for faricimab or aflibercept 8 mg, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye
- Any history of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)
- Active ocular inflammation of any history of intraocular inflammation within 1 year
- Aphakia or total absence of the posterior capsule; YAG laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1
See the full eligibility criteria
- ≥18 years of age
- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), HbA1c <12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
- CI-DME confirmed on SD-OCT with CST ≥320 µm in the study eye at screening
- BCVA visual acuity ETDRS letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening
- Further inclusion criteria apply
- Macular edema considered to be due to other causes than CI-DME in the study eye
- Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
- Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8 mg), and within 6 months before Day 1 for faricimab or aflibercept 8 mg, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye
- Any history of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)
- Active ocular inflammation of any history of intraocular inflammation within 1 year
- Aphakia or total absence of the posterior capsule; YAG laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1
- Further exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- China
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; 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.