RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT07553429

Registry updated: 2026-10-14

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Description

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.

Interventions

Low dose BI 3812465 (Biological)
BI 3812465
Medium dose BI 3812465 (Biological)
BI 3812465
High dose BI 3812465 (Biological)
BI 3812465

Eligibility 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.

Conditions

Diabetic Macular Edema

Locations

Associated Retina Consultants, Ltd. — Phoenix, Arizona, United States
Research Network Arizona — Scottsdale, Arizona, United States
Win Retina — Arcadia, California, United States
Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
Global Research Management — Glendale, California, United States
Retina Associates of Southern California — Huntington Beach, California, United States
California Retina Consultants-Oxnard-70187 — Oxnard, California, United States
Retinal Consultants Medical Group — Sacramento, California, United States
Bay Area Retina Associates - Walnut Creek — Walnut Creek, California, United States
Retina Group of New England, PC — Waterford, Connecticut, United States
Retina Group of Florida - Fort Myers Retina Center — Fort Myers, Florida, United States
Florida Retina Consultants — Lakeland, Florida, United States
East Florida Eye Institute — Stuart, Florida, United States
Ophthalmic Consultants of Long Island — Oceanside, New York, United States
North Carolina Retina Associates — Wake Forest, North Carolina, United States
Red River Research Partners, LLC — Fargo, North Dakota, United States
Cleveland Clinic — Cleveland, Ohio, United States
Verum Research, LLC — Eugene, Oregon, United States
EyeHealth Northwest — Portland, Oregon, United States
Tennessee Retina — Nashville, Tennessee, United States
Austin Clinical Research, LLC — Austin, Texas, United States
Retina Consultants of Texas-Bellaire-67493 — Bellaire, Texas, United States
Valley Retina Institute, PA — McAllen, Texas, United States
Medical Center Ophthalmology Associates — San Antonio, Texas, United States
Retina Consultants of Texas — San Antonio, Texas, United States
Retina Consultants of Texas-The Woodlands-67575 — The Woodlands, Texas, United States
Strategic Clinical Research Group — Willow Park, Texas, United States
Emerson Clinical Research Institute — Falls Church, Virginia, United States
Emanuelli Research & Development Center — Arecibo, Puerto Rico

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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