Diabetic Macular EdemaPhase 1/2NCT07553429
A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
A Phase 1/2 study testing Low dose BI 3812465, Medium dose BI 3812465 and High dose BI 3812465 in people with Diabetic Macular Edema, run by Boehringer Ingelheim at 29 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Low dose BI 3812465, Medium dose BI 3812465 and High dose BI 3812465
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 14 May 2026to 6 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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:
Show all 14Show fewer
- 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.
Trial locations and contacts
29 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 2 countries
United States28 sites, 28 recruiting
- Recruiting
Win Retina
Arcadia, California, 91006
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Austin Clinical Research, LLC
Austin, Texas, 78750
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Consultants of Texas-Bellaire-67493
Bellaire, Texas, 77401
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Verum Research, LLC
Eugene, Oregon, 97401
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Emerson Clinical Research Institute
Falls Church, Virginia, 22042
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Red River Research Partners, LLC
Fargo, North Dakota, 58103
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Group of Florida - Fort Myers Retina Center
Fort Myers, Florida, 33912
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Global Research Management
Glendale, California, 91204
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Retina Associates of Southern California
Huntington Beach, California, 92647
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Florida Retina Consultants
Lakeland, Florida, 33805
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Valley Retina Institute, PA
McAllen, Texas, 78503
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Tennessee Retina
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
California Retina Consultants-Oxnard-70187
Oxnard, California, 93036
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
EyeHealth Northwest
Portland, Oregon, 97225
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retinal Consultants Medical Group
Sacramento, California, 95825
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Consultants of Texas
San Antonio, Texas, 78240
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Research Network Arizona
Scottsdale, Arizona, 85255
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
East Florida Eye Institute
Stuart, Florida, 34994
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, 77384
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, 94598
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Group of New England, PC
Waterford, Connecticut, 06385
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Strategic Clinical Research Group
Willow Park, Texas, 76087
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Puerto Rico1 site, 1 recruiting
- Recruiting
Emanuelli Research & Development Center
Arecibo, 00612
Boehringer Ingelheim, 18336022368, unitedstates@bitrialsupport.com
About this study
Official title: 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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Low dose BI 3812465, Medium dose BI 3812465, High dose BI 3812465
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose BI 3812465Biological
BI 3812465
Medium dose BI 3812465Biological
BI 3812465
High dose BI 3812465Biological
BI 3812465
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Treatment arm A | Experimental | Low dose of BI 3812465. Receives: Biological: Low dose BI 3812465 |
| Part 1: Treatment arm B | Experimental | Medium dose of BI 3812465. Receives: Biological: Medium dose BI 3812465 |
| Part 1: Treatment arm C | Experimental | High dose BI 3812465. Receives: Biological: High dose BI 3812465 |
| Part 2: Treatment arm A | Experimental | Low dose BI 3812465. Receives: Biological: Low dose BI 3812465 |
| Part 2: Treatment arm B | Experimental | Medium dose BI 3812465. Receives: Biological: Medium dose BI 3812465 |
| Part 2: Treatment arm C | Experimental | High dose BI 3812465. Receives: Biological: High dose BI 3812465 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Occurrence of dose limiting events (DLEs) from first investigational medicine product (IMP) administration until end of study (EOS)
Measured: Up to 169 days.
Part 2: Occurrence of ocular adverse events (AEs) in the study eye from first IMP administration until EOS
Measured: Up to 169 days.
Secondary outcomes (3)
Occurrence of AEs from first IMP administration until EOS
Measured: Up to 169 days.
Occurrence of serious adverse events (SAEs) from first IMP administration until EOS
Measured: Up to 169 days.
Part 1: Occurrence of ocular AEs in the study eye from first IMP administration until EOS
Measured: Up to 169 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start14 May 2026
- Primary completion23 Mar 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553429
- Sponsor's protocol ID
- 1523-0001
- Other IDs
- U1111-1316-1873
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07553429
- Acronym / sponsor ID
- 1523-0001
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Treatment arm A | Experimental | Biological: Low dose BI 3812465Low dose of BI 3812465. |
| Part 1: Treatment arm B | Experimental | Biological: Medium dose BI 3812465Medium dose of BI 3812465. |
| Part 1: Treatment arm C | Experimental | Biological: High dose BI 3812465High dose BI 3812465. |
| Part 2: Treatment arm A | Experimental | Biological: Low dose BI 3812465Low dose BI 3812465. |
| Part 2: Treatment arm B | Experimental | Biological: Medium dose BI 3812465Medium dose BI 3812465. |
| Part 2: Treatment arm C | Experimental | Biological: High dose BI 3812465High dose BI 3812465. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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.
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose BI 3812465BI 3812465 | Biological | Part 1: Treatment arm A, Part 2: Treatment arm A |
| Medium dose BI 3812465BI 3812465 | Biological | Part 1: Treatment arm B, Part 2: Treatment arm B |
| High dose BI 3812465BI 3812465 | Biological | Part 1: Treatment arm C, Part 2: Treatment arm C |
Primary outcome
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.
3 secondary outcomes
Occurrence of AEs from first IMP administration until EOS
Time frame: Up to 169 days.
Occurrence of serious adverse events (SAEs) from first IMP administration until EOS
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low dose BI 3812465, Medium dose BI 3812465 and High dose BI 3812465 in people with Diabetic Macular Edema, run by Boehringer Ingelheim at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.