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NCT06957080RECRUITINGIRB Ready

A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

(BAROLO)

Sponsored by EyeBiotech Ltd.

Quick Self-Assessment

See if you qualify and express your interest

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1 of 960 participants interested
0% interest

Express Your Interest Today

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

EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME). In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.

Who Can Participate

Inclusion Criteria

Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
Be male or female โ‰ฅ18 years of age.
Have type 1 or type 2 diabetes mellitus and a HbA1c of โ‰ค12%.
Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME.

Exclusion Criteria

Be pregnant or breastfeeding
History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
Have had prior treatment with 8 mg afli

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

960 participants

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Gender

ALL

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Sponsor

EyeBiotech Ltd.

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Gilbert

Arizona

Location available
View Gilbert location page
Unknown

Phoenix

Arizona

Location available
View Phoenix location page
Unknown

Scottsdale

Arizona

Location available
View Scottsdale location page
Unknown

Fayetteville

Arkansas

Location available
View Fayetteville location page
Unknown

Bakersfield

California

Location available
View Bakersfield location page
Unknown

Encino

California

Location available
View Encino location page
Unknown

Modesto

California

Location available
View Modesto location page
Unknown

Mountain View

California

Location available
View Mountain View location page
Unknown

Redlands

California

Location available
View Redlands location page

๐Ÿ“ And 98 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 Gilbert?

Join others in Arizona exploring innovative treatment options through clinical research

Diabetic Macular Edema Treatment Options in Gilbert, Arizona

If you're searching for Diabetic Macular Edema treatment in Gilbert, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Gilbert, Phoenix, Scottsdale 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 Arizona
Now Enrolling
Up to 960 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: NCT06957080. 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.