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Monoclonal Antibodies

EYE201 for Eye Conditions

Phase 1 & 2
Recruiting
Research Sponsored by EyeBiotech Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be ≥ 50 years of age
Have Type 1 or Type 2 diabetes mellitus and a glycated hemoglobin A1c (HbA1c) of ≤ 12%
Must not have
Have uncontrolled glaucoma (defined as IOP ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye
Have had previous photodynamic therapy with Visudyne in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a new drug called EYE201 to see if it is safe and effective for treating eye conditions like branch retinal vein occlusion, diabetic macular edema, and neov

Who is the study for?
This trial is for individuals with macular edema following branch retinal vein occlusion, diabetic macular edema, or neovascular age-related macular degeneration. Participants will receive three injections of a new drug called EYE201 into the affected eye.
What is being tested?
The study tests the safety and effectiveness of EYE201 at various doses in two parts: one focusing on increasing doses for safety (12 participants) and another comparing two selected doses for efficacy (80 participants).
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to eye injections such as discomfort, redness, swelling, and possible vision changes. Safety monitoring is a key part of this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 years old or older.
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I have diabetes with an HbA1c of 12% or less.
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I have been diagnosed with BRVO in one of my eyes.
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My vision loss is mainly due to BRVO.
Select...
My vision loss is mainly due to diabetic macular edema.
Select...
My eye condition is due to AMD with a specific lesion size and activity level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My glaucoma is not under control despite medication, with an eye pressure of 25 mmHg or higher.
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I have had Visudyne therapy in my eye.
Select...
I have diabetic retinopathy in one of my eyes.
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I had a YAG laser procedure on my eye within the last 90 days.
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I have had laser therapy in the eye being studied.
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My eye condition is due to severe diabetes-related changes.
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My macular edema is not due to BRVO.
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I have a serious eye condition affecting my retina.
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I have had laser treatment in my eye.
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My eye has abnormal blood vessel growth or a specific type of glaucoma.
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My eye has abnormal blood vessel growth or a specific type of glaucoma.
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My macular edema is not due to diabetic macular edema.
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My eye condition does not involve central vision scarring or significant damage.
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My study eye has a tractional retinal detachment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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

Trial Design

8Treatment groups
Experimental Treatment
Group I: Part 2: NVAMD naïve or experienced participants - Dose 2Experimental Treatment1 Intervention
Group II: Part 2: NVAMD naïve or experienced participants - Dose 1Experimental Treatment1 Intervention
Group III: Part 2: DME naïve or experienced participants -Dose 2Experimental Treatment1 Intervention
Group IV: Part 2: DME naïve or experienced participants - Dose 1Experimental Treatment1 Intervention
Group V: Part 1 MAD - Mid-High DoseExperimental Treatment1 Intervention
Group VI: Part 1 MAD - Low-Mid DoseExperimental Treatment1 Intervention
Group VII: Part 1 MAD - Low DoseExperimental Treatment1 Intervention
Group VIII: Part 1 MAD - High DoseExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

EyeBiotech Ltd.Lead Sponsor
2 Previous Clinical Trials
993 Total Patients Enrolled
~61 spots leftby Apr 2026
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