Is NCT07553429 recruiting in Glendale, CA?

Yes, NCT07553429 is currently recruiting participants at its Glendale, CA location. This diabetic macular edema clinical trial is actively enrolling qualified participants.

How do I join the diabetic macular edema clinical trial in Glendale?

To join this clinical trial in Glendale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Glendale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetic Macular Edema Clinical Trial in Glendale, CA

About This Diabetic Macular Edema Study in Glendale

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.

Sponsor: Boehringer Ingelheim

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Glendale?

Yes, this clinical trial (NCT07553429) has an active research site in Glendale, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetic Macular Edema Treatment Options in Glendale, CA

If you're searching for diabetic macular edema treatment options in Glendale, CA, this clinical trial (NCT07553429) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Glendale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic macular edema specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetic macular edema clinical trials near you to find additional studies recruiting in your area.

Diabetic Macular Edema Clinical Trial in Glendale, CA

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