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NCT06962839RECRUITINGIRB Ready

A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

Sponsored by Boehringer Ingelheim

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose. This study has 2 parts.

Who Can Participate

Inclusion Criteria

โ‰ฅ18 years of age
Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) \<12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) โ‰ฅ320 ยตm for male and โ‰ฅ305 ยตm for female participants in the study eye at screening
Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further inclusion criteria apply.

Exclusion Criteria

Macular edema considered to be due to other causes than CI-DME in the study eye
Proliferative diabetic retinopathy or iris neovascularisation (including the anterior c

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

300 participants

โšง

Gender

ALL

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Sponsor

Boehringer Ingelheim

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Arcadia

California

Location available
View Arcadia location page
RECRUITING

Huntington Beach

California

Location available
View Huntington Beach location page
RECRUITING

Modesto

California

Location available
View Modesto location page
NOT_YET_RECRUITING

Pasadena

California

Location available
View Pasadena location page
NOT_YET_RECRUITING

Poway

California

Location available
View Poway location page
NOT_YET_RECRUITING

San Francisco

California

Location available
View San Francisco location page
NOT_YET_RECRUITING

Lakewood

Colorado

Location available
View Lakewood location page
RECRUITING

Pompano Beach

Florida

Location available
View Pompano Beach location page
NOT_YET_RECRUITING

Winter Haven

Florida

Location available
View Winter Haven location page

๐Ÿ“ And 14 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Diabetic Macular Edema Treatment in Arcadia?

Join others in California exploring innovative treatment options through clinical research

Diabetic Macular Edema Treatment Options in Arcadia, California

If you're searching for Diabetic Macular Edema treatment in Arcadia, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Arcadia, Modesto, Pasadena and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Diabetic Macular Edema. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 300 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Diabetic Macular Edema?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Diabetic Macular Edema

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Diabetic Macular Edema Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06962839. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.