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

May 31, 2026 updated by: Boehringer Ingelheim

A First-in-human, Open-label (Part 1), Randomized (Part 2), Phase I/IIa Trial to Study Safety and Tolerability of Multiple Rising Intravitreal Doses of BI 3812465 in Patients With Center-involved Diabetic Macular Edema

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

49

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Not yet recruiting
        • Emanuelli Research & Development Center
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
      • Scottsdale, Arizona, United States, 85255
    • California
      • Arcadia, California, United States, 91006
      • Bakersfield, California, United States, 93309
        • Not yet recruiting
        • California Retina Consultants-Bakersfield-65523
        • Contact:
      • Beverly Hills, California, United States, 90211
        • Not yet recruiting
        • Retina-Vitreous Associates Medical Group
        • Contact:
      • Glendale, California, United States, 91204
      • Huntington Beach, California, United States, 92647
        • Not yet recruiting
        • Retina Associates of Southern California
        • Contact:
      • Sacramento, California, United States, 95825
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • Bay Area Retina Associates - Walnut Creek
        • Contact:
    • Connecticut
      • Waterford, Connecticut, United States, 06385
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Not yet recruiting
        • Retina Group of Florida - Fort Myers Retina Center
        • Contact:
      • Lakeland, Florida, United States, 33805
      • Stuart, Florida, United States, 34994
      • Wildwood, Florida, United States, 34785
    • Maryland
      • Hagerstown, Maryland, United States, 21740
    • New York
      • Oceanside, New York, United States, 11572
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Oregon
      • Eugene, Oregon, United States, 97401
      • Portland, Oregon, United States, 97225
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78750
      • Bellaire, Texas, United States, 77401
        • Not yet recruiting
        • Retina Consultants of Texas-Bellaire-67493
        • Contact:
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78240
        • Not yet recruiting
        • Medical Center Ophthalmology Associates
        • Contact:
      • San Antonio, Texas, United States, 78240
        • Not yet recruiting
        • Retina Consultants of Texas - San Antonio Medical Center
        • Contact:
      • The Woodlands, Texas, United States, 77384
        • Not yet recruiting
        • Retina Consultants of Texas-The Woodlands-67575
        • Contact:
      • Weatherford, Texas, United States, 76087
    • Virginia
      • Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Treatment arm A
Low dose of BI 3812465.
Biological: Low dose BI 3812465
BI 3812465
Experimental: Part 1: Treatment arm B
Medium dose of BI 3812465.
Biological: Medium dose BI 3812465
BI 3812465
Experimental: Part 1: Treatment arm C
High dose BI 3812465.
Biological: High dose BI 3812465
BI 3812465
Experimental: Part 2: Treatment arm A
Low dose BI 3812465.
Biological: Low dose BI 3812465
BI 3812465
Experimental: Part 2: Treatment arm B
Medium dose BI 3812465.
Biological: Medium dose BI 3812465
BI 3812465
Experimental: Part 2: Treatment arm C
High dose BI 3812465.
Biological: High dose BI 3812465
BI 3812465

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: Occurrence of dose limiting events (DLEs) from first investigational medicine product (IMP) administration until end of study (EOS)
Time Frame: Up to 169 days.
Up to 169 days.
Part 2: Occurrence of ocular adverse events (AEs) in the study eye from first IMP administration until EOS
Time Frame: Up to 169 days.
Up to 169 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of AEs from first IMP administration until EOS
Time Frame: Up to 169 days.
Up to 169 days.
Occurrence of serious adverse events (SAEs) from first IMP administration until EOS
Time Frame: Up to 169 days.
Up to 169 days.
Part 1: Occurrence of ocular AEs in the study eye from first IMP administration until EOS
Time Frame: Up to 169 days.
Up to 169 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2026

Primary Completion (Estimated)

March 23, 2027

Study Completion (Estimated)

July 6, 2027

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1523-0001
  • U1111-1316-1873 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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