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New treatment option for Diabetic Macular Edema
Official title A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
ClinicalTrials.gov ID: NCT07553429
What this study is testing
What is Low dose BI 3812465?
Low dose BI 3812465 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join 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...
- 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...
- 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:
See the full eligibility 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...
- 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 apply.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Arcadia, California, United States
- Beverly Hills, California, United States
- Glendale, California, United States
- Huntington Beach, California, United States
- Oxnard, California, United States
- Sacramento, California, United States
- Walnut Creek, California, United States
- Waterford, Connecticut, United States
- Fort Myers, Florida, United States
- Lakeland, Florida, United States
- Stuart, Florida, United States
- Wildwood, Florida, United States
- Oceanside, New York, United States
- Wake Forest, North Carolina, United States
- Fargo, North Dakota, United States
- Cleveland, Ohio, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
+ 9 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Arcadia, California, United States; Beverly Hills, California, United States; Glendale, California, United States; Huntington Beach, California, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.