Testing Different Doses of BI 3812465 in Diabetic Macular Edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study has two parts. Part 1 tests low, medium, and high doses to see what patients can tolerate, starting with the lowest dose and moving up if tolerated. Part 2 expands to more participants in each dose group. All participants receive three injections into the eye over up to 7 months, with most visits possible at home where feasible. The trial evaluates safety and tolerability in adults with center-involved DME treated under standard diabetes care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All participants, study eye:

* Center-involved diabetic macular edema (CI-DME) defined as CST ≥320 μm (micrometers) at Screening, as confirmed on spectral-domain optical coherence tomography (SD-OCT) and confirmed by the central reading center (CRC).
* Sufficiently clear ocular media, adequate pupillary dilation, and fixation, to permit quality fundus imaging.

All participants:

* Diagnosis of diabetes mellitus (DM) type 1 or type 2 under regular treatment, with glycated hemoglobin HbA1c \<12%.
* Be willing and able to understand the study procedures and the risks involved.
* Signed and dated written informed consent in accordance with international council for harmonization - good clinical practices (ICH-GCP) and local legislation prior to admission to the trial and any trial related procedures.
* Age ≥18 years (or above legal age according to local legislation) at time of signing the informed consent form (ICF).
* Male or female participants

  * Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control
  * For men, contraception (condom or complete abstinence) should be used as precaution to prevent pregnancy of a partner and/or exposure of an existing embryo or fetus.

Further inclusion criteria apply.

Exclusion Criteria:

All participants, study eye:

* Only one functional eye, even if that eye was otherwise eligible for the study. Fellow eye must have sufficient visual function per the investigator's medical judgment in consultation with the participant, to support the participant's daily functioning.
* Evidence of active proliferative diabetic retinopathy (PDR).
* Evidence of active retinal neovascularization (NV) clinical exam and/or Ultra-Widefield Color Fundus Photography ((UWF-)CFP) within the early treatment diabetic retinopathy study (ETDRS) 7-field, confirmed by the CRC grading. Potential participants with NV outside of the ETDRS 7-field on ultra-widefield imaging may be included in the trial if this condition, based on the assessment of the investigator, does not require acute treatment.
* Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle.
* Additional eye disease in the study eye that could compromise trial participation:

  * Uncontrolled glaucoma or intraocular pressure (IOP) \>24 mmHg despite treatment
  * History of high myopia \>8 diopters in the study eye
  * Anterior segment and vitreous abnormalities in the study eye that would preclude adequate detection of intraocular inflammation (IOI) or other pathologies
  * Ocular conditions which, at discretion of the investigator, might interfere with the outcome of the trial.
* Previously received ocular gene therapy or cell therapy.
* Corticosteroid use locally or systemically within 1 month prior to Screening.
* Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy may be permitted, if performed more than 2 months prior to Day 1.

Further exclusion criteria apply.

Where it's running

• Associated Retina Consultants, Ltd.
  Phoenix, Arizona, United States Recruiting
• Research Network Arizona
  Scottsdale, Arizona, United States Recruiting
• Win Retina
  Arcadia, California, United States Recruiting
• Retina-Vitreous Associates Medical Group
  Beverly Hills, California, United States Recruiting
• Global Research Management
  Glendale, California, United States Recruiting
• California Retina Consultants-Oxnard-70187
  Oxnard, California, United States Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blepharoptosis After Repeated Anti-VEGF Injections in One Eye

  This study tests whether repeated intravitreal anti-VEGF injections in one eye affect eyelid position compared with the untreated fellow eye.

  Recruiting Fatih Sultan Mehmet Training and Research Hospital · Istanbul · NCT07821450

• Comparing AVT29 and Eylea HD for diabetic macular edema

  This study will test whether AVT29 works as well and is as safe as Eylea HD in adults with center-involving diabetic macular edema who have reduced vision.

  Recruiting Phase 3 Alvotech Swiss AG · Budapest · NCT07489131

• Daily oral Kamuvudine-9 (K9) for diabetic macular edema

  This trial will test whether taking oral K9 twice daily is safe and improves vision in adults with diabetic macular edema.

  Recruiting Phase 1/2 Vistar Eye Center · Roanoke, Virginia · NCT07458061

• RO7823653 injections, alone or with faricimab, for diabetic macular edema

  This research tests injections of RO7823653, given alone or with faricimab, in people with diabetic macular edema to see if the medication is safe and how the eye handles it.

  Recruiting at 12 sites Phase 1 Genentech, Inc. · Peoria, Arizona and 11 other locations · NCT07425522

• Lactobacillus plantarum 299v Probiotic for Diabetic Macular Edema

  A probiotic pill taken twice daily for four months is tested to see if it can help people with diabetic macular edema see better or need fewer eye injections.

  Recruiting Phase 2 Massachusetts Eye and Ear Infirmary · Boston, Massachusetts · NCT07383701

• Early progression of non-center diabetic macular edema after phacoemulsification

  This will see if non-center-involving diabetic macular edema worsens in the early weeks after cataract surgery in adults with diabetes.

  Recruiting Ain Shams University · Cairo · NCT07038967

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.