What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

The most common treatments for Diabetic Macular Edema (DME) include anti-VEGF agents and corticosteroids. Anti-VEGF agents, such as ranibizumab and aflibercept, can cause side effects like eye pain, vitreous floaters, increased intraocular pressure, and rarely, endophthalmitis. Corticosteroids, such as dexamethasone implants, may lead to cataracts, elevated intraocular pressure, and glaucoma. Both treatments require careful monitoring to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Diabetic Macular Edema (DME), primarily focusing on anti-VEGF therapies such as Ranibizumab (Lucentis), Aflibercept (Eylea), and Bevacizumab (Avastin), which inhibit abnormal blood vessel growth and fluid leakage. Additionally, corticosteroid treatments like Dexamethasone intravitreal implant (Ozurdex) and Fluocinolone acetonide implant (Iluvien) are also approved, targeting inflammation and edema in the retina.

What other types of research exist?

Promising novel alternatives to EYE103 for Diabetic Macular Edema patients in 2024 include Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, and KSI-301, an anti-VEGF antibody biopolymer conjugate designed for extended durability. Both treatments have shown encouraging results in clinical trials, offering potential improvements in efficacy and dosing frequency.

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Monoclonal Antibodies

EYE103 for Diabetic Eye Conditions (AMARONE Trial)

Phase 1 & 2

Waitlist Available

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

No Placebo-Only Group

Summary

This trial is testing a new treatment called EYE103 for patients with specific eye conditions. It aims to reduce swelling and abnormal blood vessel growth in the eye. The study will check if EYE103 is safe and effective.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Secondary study objectives

Best-corrected Visual Acuity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EYE103

2023

Completed Phase 2

~40

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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.