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Recruiting Phase 1/2

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

NCT07553429 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2026-05-14
Last updated
2026-10-14

Condition(s) studied

Diabetic Macular Edema

Investigational drug(s) / intervention(s)

Low dose BI 3812465Medium dose BI 3812465High dose BI 3812465

Low dose BI 3812465: BI 3812465

Medium dose BI 3812465: BI 3812465

High dose BI 3812465: BI 3812465

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (29)

FacilityCityRegionStatus
Associated Retina Consultants, Ltd. Phoenix Arizona Recruiting
Research Network Arizona Scottsdale Arizona Recruiting
Win Retina Arcadia California Recruiting
Retina-Vitreous Associates Medical Group Beverly Hills California Recruiting
Global Research Management Glendale California Recruiting
Retina Associates of Southern California Huntington Beach California Not Yet Recruiting
California Retina Consultants-Oxnard-70187 Oxnard California Recruiting
Retinal Consultants Medical Group Sacramento California Recruiting
Bay Area Retina Associates - Walnut Creek Walnut Creek California Recruiting
Retina Group of New England, PC Waterford Connecticut Recruiting
Retina Group of Florida - Fort Myers Retina Center Fort Myers Florida Recruiting
Florida Retina Consultants Lakeland Florida Recruiting
East Florida Eye Institute Stuart Florida Recruiting
Ophthalmic Consultants of Long Island Oceanside New York Recruiting
North Carolina Retina Associates Wake Forest North Carolina Recruiting
Red River Research Partners, LLC Fargo North Dakota Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Verum Research, LLC Eugene Oregon Recruiting
EyeHealth Northwest Portland Oregon Recruiting
Tennessee Retina Nashville Tennessee Recruiting
Austin Clinical Research, LLC Austin Texas Recruiting
Retina Consultants of Texas-Bellaire-67493 Bellaire Texas Recruiting
Valley Retina Institute, PA McAllen Texas Recruiting
Medical Center Ophthalmology Associates San Antonio Texas Recruiting
Retina Consultants of Texas San Antonio Texas Recruiting
Retina Consultants of Texas-The Woodlands-67575 The Woodlands Texas Not Yet Recruiting
Strategic Clinical Research Group Willow Park Texas Recruiting
Emerson Clinical Research Institute Falls Church Virginia Recruiting
Emanuelli Research & Development Center Arecibo Puerto Rico Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07553429 on ClinicalTrials.gov ↗ ← All trials in the USA