Macular Edema study: BI
Official title A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
ClinicalTrials.gov ID: NCT06962839
What this study is testing
What is BI 1815368?
an investigational oral tablet being studied as a potential treatment for centre‑involved diabetic macular edema
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether BI 1815368 improves vision in people with centre‑involved diabetic macular edema and what dose works best.
- Who it's for
- You may be able to join if you are 18 or older and have centre‑involved diabetic macular edema.
- What's involved
- You would take two tablets a day for about 11 months. You will visit the study site at least 16 times to have your vision checked and eye pictures taken. If you take metformin, you will have 3 extra visits.
- Time commitment
- The study lasts about one year, with many visits to the clinic for eye exams and health checks.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years of age
- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) \<12% treated with stable medication for at least 30 days prior to...
- Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal...
- Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78...
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
- Intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye is not allowed within 8 weeks prior to Day 1, except for...
- Any history of panretinal photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1)...
- Prior macular laser photocoagulation performed more than 3 months prior to Day 1 is permitted if absence of scar-like changes within the 1-mm...
- Active ocular inflammation or any history of intraocular inflammation within 1 year
See the full eligibility criteria
- ≥18 years of age
- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (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.
- Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm in the study eye at screening
- Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further 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
- Intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye is not allowed within 8 weeks prior to Day 1, except for faricimab or aflibercept 8 mg, for which a 16-week washout period...
- Any history of panretinal photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of fluocinolone ophthalmic implant or dexamethasone IVT implant...
- Prior macular laser photocoagulation performed more than 3 months prior to Day 1 is permitted if absence of scar-like changes within the 1-mm diameter region centred on the fovea is confirmed by the CRC at screening...
- Active ocular inflammation or any history of intraocular inflammation within 1 year
- Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (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 is enrolling
- Phoenix, Arizona, United States
- Arcadia, California, United States
- Huntington Beach, California, United States
- Modesto, California, United States
- Newport Beach, California, United States
- Pasadena, California, United States
- Poway, California, United States
- San Francisco, California, United States
- Lakewood, Colorado, United States
- Pompano Beach, Florida, United States
- Winter Haven, Florida, United States
- Carmel, Indiana, United States
- Kansas City, Kansas, United States
- Hagerstown, Maryland, United States
- Reno, Nevada, United States
- Wake Forest, North Carolina, United States
- Cleveland, Ohio, United States
- Eugene, Oregon, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
+ 52 more site(s).
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Arcadia, California, United States; Huntington Beach, California, United States; Modesto, California, United States; Newport Beach, California, United States; Pasadena, California, United States and 66 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.