Status:
RECRUITING
A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic mac...
Eligibility Criteria
Inclusion 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. start of new medication) at the time of screening and baseline
- 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 inclusion criteria apply.
Exclusion criteria:
- 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 intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8mg), 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 of 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; 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.
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06962839
Start Date
June 5 2025
End Date
September 29 2027
Last Update
April 15 2026
Active Locations (80)
Enter a location and click search to find clinical trials sorted by distance.
1
Win Retina
Arcadia, California, United States, 91006
2
Retina Associates of Southern California
Huntington Beach, California, United States, 92647
3
Retinal Consultants Medical Group, Inc
Modesto, California, United States, 95356
4
Doheny Eye Center UCLA Arcadia
Pasadena, California, United States, 91103