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Monoclonal Antibodies

EYE103 for Diabetic Eye Conditions (AMARONE Trial)

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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

AMARONE Trial Summary

This trial tests a potential drug to help people with vision problems caused by diabetes or macular degeneration. It will assess its safety and effectiveness.

Who is the study for?
This trial is for adults with diabetic macular edema (DME) who are at least 18 years old and have not been treated before, or those with neovascular age-related macular degeneration (NVAMD) who are 50 or older. Participants must understand the study, agree to its procedures, and have vision loss in the affected eye.Check my eligibility
What is being tested?
The study tests EYE103's safety and effectiveness for DME as a single treatment and NVAMD in combination with anti-VEGF. It has two parts: first, escalating doses to check safety; second, comparing two selected doses to see which works better.See study design
What are the potential side effects?
While specific side effects of EYE103 aren't listed here, similar treatments may cause eye irritation or discomfort, increased eye pressure, bleeding inside the eye, cataract formation or worsening of existing cataracts.

AMARONE Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Secondary outcome measures
Best-corrected Visual Acuity

AMARONE Trial Design

10Treatment groups
Experimental Treatment
Group I: Naïve NVAMD Medium DoseExperimental Treatment1 Intervention
Part 2 Naïve NVAMD combination therapy Medium Dose
Group II: Naïve NVAMD High DoseExperimental Treatment1 Intervention
Part 2 Naïve NVAMD combination therapy High Dose
Group III: Experienced NVAMD Medium DoseExperimental Treatment1 Intervention
Part 2 Experienced NVAMD combination therapy Medium Dose
Group IV: Experienced NVAMD High DoseExperimental Treatment1 Intervention
Part 2 Experienced NVAMD combination therapy High Dose
Group V: Dose 4Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 4 - High Dose
Group VI: Dose 3Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 3 - Mid-High Dose
Group VII: Dose 2Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 2 - Low-Mid Dose
Group VIII: Dose 1Experimental Treatment1 Intervention
Part 1 MAD Portion Dose 1 - Low Dose
Group IX: DME Medium DoseExperimental Treatment1 Intervention
Part 2 Naïve DME monotherapy Medium Dose
Group X: DME High DoseExperimental Treatment1 Intervention
Part 2 Naïve DME monotherapy High Dose

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Diabetic Macular Edema (DME) include anti-VEGF (vascular endothelial growth factor) therapies. These treatments work by inhibiting VEGF, a protein that promotes abnormal blood vessel growth and leakage in the retina, leading to macular edema. By blocking VEGF, these therapies reduce fluid accumulation and swelling in the macula, improving or stabilizing vision. This mechanism is crucial for DME patients as it directly addresses the underlying cause of vision impairment, offering a targeted approach to preserve and enhance visual function.

Find a Location

Who is running the clinical trial?

EyeBiotech Ltd.Lead Sponsor

Media Library

EYE103 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05919693 — Phase 1 & 2
Diabetic Macular Edema Research Study Groups: Dose 1, Dose 2, Dose 3, Dose 4, DME Medium Dose, DME High Dose, Naïve NVAMD Medium Dose, Naïve NVAMD High Dose, Experienced NVAMD Medium Dose, Experienced NVAMD High Dose
Diabetic Macular Edema Clinical Trial 2023: EYE103 Highlights & Side Effects. Trial Name: NCT05919693 — Phase 1 & 2
EYE103 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919693 — Phase 1 & 2
~31 spots leftby Dec 2024