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RecruitingPhase 1/Phase 2

A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated

Boehringer Ingelheim · NCT07553429

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
49
US sites recruiting
25
Study start
May 14, 2026
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study is open to adults with diabetic macular edema that involves the center of the eye. The purpose of this study is to find out how well different doses of a medicine called BI 3812465 are tolerated by people with this condition. This is the first time BI 3812465 is given to humans.

This study has 2 parts. In Part 1, a small number of participants receive low, medium, or high doses of BI 3812465. The first participants to start the study get low doses of BI 3812465. Participants who start later get higher doses only if the lower doses were tolerated. In Part 2, a larger number of participants are placed into low, medium, or high dose groups. Participants in both parts of the study get BI 3812465 as injections into the back of the eye for a total of 3 eye injections.

Participants are in the study for up to 7 months. During this time, they visit the study site 19 times. Where possible, some visits can be done at the participant's home instead of the study site. At study visits, the doctors check the severity of participants' eye condition and note any health problems that could have been caused by BI 3812465.

Being studied: Low dose BI 3812465; Medium dose BI 3812465; High dose BI 3812465

Conditions: Diabetic Macular Edema

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Associated Retina Consultants, Ltd.

    Phoenix, AZ 85020

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Research Network Arizona

    Scottsdale, AZ 85255

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Win Retina

    Arcadia, CA 91006

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, CA 90211

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Global Research Management

    Glendale, CA 91204

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • California Retina Consultants-Oxnard-70187

    Oxnard, CA 93036

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Retinal Consultants Medical Group

    Sacramento, CA 95825

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, CA 94598

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Retina Group of New England, PC

    Waterford, CT 06385

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Retina Group of Florida - Fort Myers Retina Center

    Fort Myers, FL 33912

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Florida Retina Consultants

    Lakeland, FL 33805

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • East Florida Eye Institute

    Stuart, FL 34994

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Ophthalmic Consultants of Long Island

    Oceanside, NY 11572

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • North Carolina Retina Associates

    Wake Forest, NC 27587

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Red River Research Partners, LLC

    Fargo, ND 58103

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Verum Research, LLC

    Eugene, OR 97401

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • EyeHealth Northwest

    Portland, OR 97225

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Tennessee Retina

    Nashville, TN 37203

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Austin Clinical Research, LLC

    Austin, TX 78750

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Retina Consultants of Texas-Bellaire-67493

    Bellaire, TX 77401

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Valley Retina Institute, PA

    McAllen, TX 78503

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Medical Center Ophthalmology Associates

    San Antonio, TX 78240

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Retina Consultants of Texas

    San Antonio, TX 78240

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Strategic Clinical Research Group

    Willow Park, TX 76087

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Emerson Clinical Research Institute

    Falls Church, VA 22042

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

Study contacts (from the official record)

  • Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
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A Study in People With Diabetic Macular Edema to Test How Well… (NCT07553429) | Bored Studies