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

NCT07553429 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1523-0001U1111-1316-1873
• Study Type: interventional
• Target: 49
• Locations: 2 countries
• Sites: 27

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

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• Occurrence of AEs from first IMP administration until EOS

  Up to 169 days.

• Occurrence of serious adverse events (SAEs) from first IMP administration until EOS

  Up to 169 days.

• Part 1: Occurrence of ocular AEs in the study eye from first IMP administration until EOS

  Up to 169 days.

Study Arms (6)

Part 1: Treatment arm A

EXPERIMENTAL

Low dose of BI 3812465.

Biological: Low dose BI 3812465

Part 1: Treatment arm B

EXPERIMENTAL

Medium dose of BI 3812465.

Biological: Medium dose BI 3812465

Part 1: Treatment arm C

EXPERIMENTAL

High dose BI 3812465.

Biological: High dose BI 3812465

Part 2: Treatment arm A

EXPERIMENTAL

Low dose BI 3812465.

Biological: Low dose BI 3812465

Part 2: Treatment arm B

EXPERIMENTAL

Medium dose BI 3812465.

Biological: Medium dose BI 3812465

Part 2: Treatment arm C

EXPERIMENTAL

High dose BI 3812465.

Biological: High dose BI 3812465

Interventions

Low dose BI 3812465 BIOLOGICAL

BI 3812465

Part 1: Treatment arm A; Part 2: Treatment arm A

Medium dose BI 3812465 BIOLOGICAL

BI 3812465

Part 1: Treatment arm B; Part 2: Treatment arm B

High dose BI 3812465 BIOLOGICAL

BI 3812465

Part 1: Treatment arm C; Part 2: Treatment arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (27)

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, United States

Location

Win Retina

Arcadia, California, 91006, United States

Location

California Retina Consultants-Bakersfield-65523

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Bay Area Retina Associates - Walnut Creek

Walnut Creek, California, 94598, United States

Location

Retina Group of New England, PC

Waterford, Connecticut, 06385, United States

Location

Retina Group of Florida - Fort Myers Retina Center

Fort Myers, Florida, 33912, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Florida Retina Institute Wildwood

Wildwood, Florida, 34785, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

North Carolina Retina Associates

Wake Forest, North Carolina, 27587, United States

Location

Red River Research Partners, LLC

Fargo, North Dakota, 58103, United States

Location

Verum Research, LLC

Eugene, Oregon, 97401, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas-Bellaire-67493

Bellaire, Texas, 77401, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas - San Antonio Medical Center

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas-The Woodlands-67575

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group

Weatherford, Texas, 76087, United States

Location

Emerson Clinical Research Institute

Falls Church, Virginia, 22042, United States

Location

Emanuelli Research & Development Center

Arecibo, 00612, Puerto Rico

Location

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Part 1 is open-label and Part 2 is single-blinded to the participant.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is conducted in model-based dose escalation design and Part 2 is a randomized, multi arm, parallel group, active treatment only dose expansion design, with no placebo or control arm.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 28, 2026
• Study Start (Estimated): May 14, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (26); PR (1)