Recruiting
Phase 1
Phase 2

BI 3812465

Sponsor:

Boehringer Ingelheim

Code:

NCT07553429

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low dose BI 3812465

Medium dose BI 3812465

High dose BI 3812465

Study Details

Brief summary:

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.

Conditions

Diabetic Macular Edema

Study ID

NCT07553429

Start date

May 14, 2026

Status verified date

Sep, 2026

Completion date

Jul 6, 2027

Anticipated

Primary completion date

Mar 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

49 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Treatment arm A

Low dose of BI 3812465.

experimental: Part 1: Treatment arm B

Medium dose of BI 3812465.

experimental: Part 1: Treatment arm C

High dose BI 3812465.

experimental: Part 2: Treatment arm A

Low dose BI 3812465.

experimental: Part 2: Treatment arm B

Medium dose BI 3812465.

experimental: Part 2: Treatment arm C

High dose BI 3812465.

Interventions

Low dose BI 3812465

BI 3812465

Medium dose BI 3812465

BI 3812465

High dose BI 3812465

BI 3812465

Primary outcome measure

  • 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. ]
  • Part 2: Occurrence of ocular adverse events (AEs) in the study eye from first IMP administration until EOS [ Time Frame: Up to 169 days. ]

Central Contacts and Locations

Central contacts

Locations

Research Network Arizona

Recruiting

Scottsdale, Arizona, United States, 85255

Contacts

Win Retina

Recruiting

Arcadia, California, United States, 91006

Contacts

Retina-Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Global Research Management

Recruiting

Glendale, California, United States, 91204

Contacts

California Retina Consultants-Oxnard-70187

Recruiting

Oxnard, California, United States, 93036

Contacts

Retinal Consultants Medical Group

Recruiting

Sacramento, California, United States, 95825

Contacts

Bay Area Retina Associates - Walnut Creek

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Retina Group of New England, PC

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Retina Group of Florida - Fort Myers Retina Center

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Florida Retina Consultants

Recruiting

Lakeland, Florida, United States, 33805

Contacts

East Florida Eye Institute

Recruiting

Stuart, Florida, United States, 34994

Contacts

Ophthalmic Consultants of Long Island

Recruiting

Oceanside, New York, United States, 11572

Contacts

North Carolina Retina Associates

Recruiting

Wake Forest, North Carolina, United States, 27587

Contacts

Red River Research Partners, LLC

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

Verum Research, LLC

Recruiting

Eugene, Oregon, United States, 97401

Contacts

EyeHealth Northwest

Recruiting

Portland, Oregon, United States, 97225

Contacts

Tennessee Retina

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Austin Clinical Research, LLC

Recruiting

Austin, Texas, United States, 78750

Contacts

Valley Retina Institute, PA

Recruiting

McAllen, Texas, United States, 78503

Contacts

Medical Center Ophthalmology Associates

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Strategic Clinical Research Group

Recruiting

Willow Park, Texas, United States, 76087

Contacts

Emerson Clinical Research Institute

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-09-03.