EYE103 for Diabetic Eye Conditions

(AMARONE Trial)

Recruiting at 30 trial locations

Overseen By Keith Baker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: EyeBiotech Ltd.

Disqualifiers: Pregnancy, Breastfeeding, Recent eye surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are a DME patient, you must not have received any prior treatment for your condition.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with DME and have not received any treatments, or I have NVAMD and may or may not have received treatments.

I understand the study and its risks and am willing to sign consent.

I have vision loss in one eye due to diabetic macular edema.

Exclusion Criteria

Be pregnant or breastfeeding

I had cataract or glaucoma surgery less than 3 months ago.

I had a YAG laser eye procedure within the last 2 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple Ascending Dose (MAD) Safety Study

The safety of EYE103 is assessed at escalating doses in approximately 12 participants

3 months

Dose-finding Comparative Safety and Efficacy Study

Two doses of EYE103 are selected and their effectiveness is compared in approximately 80 participants

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EYE103

Trial Overview 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.

Participant Groups

Group I: Naïve NVAMD Medium Dose Experimental Treatment 1 Intervention

Part 2 Naïve NVAMD combination therapy Medium Dose

Group II: Naïve NVAMD High Dose Experimental Treatment 1 Intervention

Part 2 Naïve NVAMD combination therapy High Dose

Group III: Experienced NVAMD Medium Dose Experimental Treatment 1 Intervention

Part 2 Experienced NVAMD combination therapy Medium Dose

Group IV: Experienced NVAMD High Dose Experimental Treatment 1 Intervention

Part 2 Experienced NVAMD combination therapy High Dose

Group V: Dose 4 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 4 - High Dose

Group VI: Dose 3 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 3 - Mid-High Dose

Group VII: Dose 2 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 2 - Low-Mid Dose

Group VIII: Dose 1 Experimental Treatment 1 Intervention

Part 1 MAD Portion Dose 1 - Low Dose

Group IX: DME Medium Dose Experimental Treatment 1 Intervention

Part 2 Naïve DME monotherapy Medium Dose

Group X: DME High Dose Experimental Treatment 1 Intervention

Part 2 Naïve DME monotherapy High Dose

Who Is Running the Clinical Trial?

EyeBiotech Ltd.

Lead Sponsor

Trials

3

Recruited

1,100+