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Monoclonal Antibodies

EYE103 for Diabetic Macular Edema (BRUNELLO Trial)

Phase 2 & 3
Recruiting
Research Sponsored by EyeBiotech Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME
Have type 1 or type 2 diabetes mellitus and a HbA1c of ≤12%
Must not have
History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of the study, through week 104
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment called EYE103 for diabetic macular edema against the current standard treatment, ranibizumab. Patients will receive treatment every 4 weeks for the first

Who is the study for?
This trial is for individuals with diabetic macular edema (DME), a condition causing swelling in the retina due to diabetes. Participants should have this specific eye condition and be willing to receive treatments every 4 weeks for at least one year, with possible adjustments thereafter.
What is being tested?
The study compares two doses of a new medication called EYE103 against an established treatment, Ranibizumab, for DME. It's randomized and double-masked, meaning neither participants nor researchers know who gets which treatment. The goal is to determine the effectiveness and safety of EYE103.
What are the potential side effects?
While specific side effects are not listed here, similar medications often cause eye irritation or discomfort, increased eye pressure, bleeding inside the eye, and vision changes. Systemic side effects may include headache and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision loss is mainly due to diabetic macular edema.
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I have diabetes with an HbA1c of 12% or less.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had cataract or glaucoma surgery in my study eye within the last 3 months.
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I am not taking any medications known to harm the retina.
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I have received an eye injection with anti-VEGF drugs in the last 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the study, through week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the study, through week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
Secondary study objectives
Changes in structural and visual outcomes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: EYE103 Low Dose Treatment ArmExperimental Treatment1 Intervention
EYE103 Low Dose Treatment Arm
Group II: EYE103 High Dose Treatment ArmExperimental Treatment1 Intervention
EYE103 High Dose Treatment Arm
Group III: Ranibizumab Treatment ArmActive Control1 Intervention
Ranibizumab Treatment Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EYE103
2023
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

EyeBiotech Ltd.Lead Sponsor
2 Previous Clinical Trials
125 Total Patients Enrolled
Charles Miller, MD PhDStudy DirectorEyeBiotech Ltd.
~640 spots leftby Dec 2027
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