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BI 1815368 for centre-involved diabetic macular edema.

A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)

Phase 2 Interventional Boehringer Ingelheim · NCT06962839

This study will test whether the oral medicine BI 1815368 can improve vision in adults with centre-involved diabetic macular edema and determine the best dose.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionsfaricimab
Locations80 sites (Arcadia, California and 79 other locations)
Trial IDNCT06962839 on ClinicalTrials.gov

What this trial studies

Adults with centre-involved diabetic macular edema confirmed by SD-OCT and meeting visual acuity and diabetes control criteria are enrolled for about one year. The trial has two randomized parts: Part 1 randomizes participants 1:1 to BI 1815368 or matching placebo, and Part 2 randomizes participants 1:1:1:1 to three different daily doses of BI 1815368 or placebo. All participants take tablets twice daily for roughly 11 months while undergoing scheduled eye exams and imaging to track vision and retinal thickness. The main goals are to see if BI 1815368 improves sight and to identify the most suitable dose.

Who should consider this trial

Good fit: Adults (≥18 years) with type 1 or type 2 diabetes, stable diabetes medications and HbA1c <12%, centre-involved DME with central subfield thickness ≥320 µm on SD-OCT, and best-corrected ETDRS vision between 24 and 78 letters are ideal candidates.

Not a fit: People whose macular edema is due to causes other than CI-DME, those with proliferative diabetic retinopathy or iris neovascularization in the study eye, or those with recent or planned intraocular treatments are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, BI 1815368 could improve vision and provide an oral treatment alternative to injections for people with CI-DME.

How similar studies have performed: Approved DME treatments are mainly intravitreal anti-VEGF injections and successful oral therapies for DME are limited, so an effective oral agent would be a relatively novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Arcadia, California and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Macular Edema
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.